ILUMIEN III: OPTIMIZE PCI: Multicenter Randomized Trial of OCT Compared to IVUS and Angiography to Guide Coronary Stent Implantation

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02471586
• Collaborator: Cardiovascular Research Foundation, New York (Other)
• Enrollment: 450
• Locations: 29
• Arms: 3
• Actual Duration (Months): 23.8
• Patients Per Site: 15.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Procedure: Coronary PCI guided by IVUS; Procedure: Coronary PCI guided by OCT; Procedure: Coronary PCI guided by Angiography	N/A

Detailed Description

This is a prospective, post-market, international, multi-center, randomized clinical investigation in which the participants will be randomized in 1:1:1 ratio to undergo PCI with either OCT, IVUS, or Angiography guidance. The clinical investigation will be conducted at approximately 35 sites in the United States and outside the United States; approximately 25% of subjects will be enrolled in the United States.

Patients in the IVUS and OCT groups patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group and IVUS groups will undergo a blinded post-PCI OCT run to allow comparison of OCT derived minimum stent area (MSA) in both groups.

After hospital discharge, all patients will have clinical follow-up at 30 days, and 1 year.

Study Design

• Study Type: Interventional
• Actual Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: For those subjects randomized to the IVUS or Angiography treatment arms, the operating investigator at the site was blinded to the final post-PCI OCT run for the subject.
• Primary Purpose: Treatment
• Official Title: ILUMIEN III: OPTIMIZE PCI: OPtical Coherence Tomography (OCT) Compared to Intravascular Ultrasound (IVUS) and Angiography to Guide Coronary Stent Implantation: a Multicenter RandomIZEd Trial in Percutaneous Coronary Intervention (PCI)
• Actual Study Start Date: May 1, 2015
• Actual Primary Completion Date: Apr 5, 2016
• Actual Study Completion Date: Apr 25, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Coronary PCI guided by IVUS Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results.	Procedure: Coronary PCI guided by IVUS; Imaging type; Other Names: Intravascular Ultrasound
Active Comparator: Coronary PCI guided by OCT Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed.	Procedure: Coronary PCI guided by OCT; Imaging type; Other Names: Optical Coherence Tomography
Active Comparator: Coronary PCI guided by Angiography Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.	Procedure: Coronary PCI guided by Angiography; Imaging type

Outcome Measures

Primary Outcome Measures

1. Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA) [Post-procedure within 1 hour]

   Post-PCI MSA will be assessed by OCT in each randomized arm, measured at the independent OCT core laboratory blinded to imaging modality assignment. Hierarchal manner testing will be as follows: Non-inferiority: OCT vs. IVUS guided stenting Non-inferiority of OCT guided stenting to IVUS guided stenting will be analyzed for the mean difference between the post PCI MSA for the OCT and IVUS arms with non-inferiority margin of 1.0 mm^2. Superiority: OCT vs. Angiography guided stenting If the OCT guided stenting arm was found to be non-inferior to the IVUS guided stenting arm, the superiority of OCT to angiography will be tested for the mean difference between the post PCI MSA for the OCT and angiography arms. Superiority: OCT vs. IVUS guided stenting If the OCT guided stenting arm was found to be superior to the IVUS guided stenting arm, then the superiority of OCT to IVUS will be tested for the mean difference between the post PCI MSA for the OCT and IVUS arms.

2. Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) [During procedure, an average of 1 hour]

   Procedural MACE defined as procedural complications (angiographic dissection, perforation, thrombus, and acute closure) requiring active interventions (prolonged balloon inflations, additional stent implantations, pericardiocentesis, thrombus aspiration and other).

Secondary Outcome Measures

1. Number of Participants With Acute Procedural Success [During procedure, an average of 1 hour]

   Acute procedural success are classified as: A) Optimal (%) The MSA of the proximal segment is ≥95% of the proximal reference lumen area and the MSA of the distal segment is ≥95% of the distal reference lumen area. B) Acceptable (%) The MSA of the proximal segment is ≥90% and <95% of the proximal reference lumen area and the MSA of the distal segment is ≥90% and <95% of the distal reference lumen area. C) Optimal and Acceptable (%) The MSA of the proximal segment is ≥90% and <95% of the proximal reference lumen area and the MSA of the distal segment is ≥90% and <95% of the distal reference lumen area. D) Unacceptable (%) The MSA of the proximal segment is <90% of the proximal lumen area, and/or the MSA of the distal segment is <90% of the distal reference lumen area.

2. Rate of Post-PCI Stent Expansion (%) [Up to 1 hour post-procedure]

   Post-PCI stent expansion is defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100.

3. Rate of Mean Stent Expansion (%) [During procedure, an average of 1 hour]

   Mean stent expansion is defined as the mean stent area (stent volume/analyzed stent length) divided by the average of proximal and distal reference lumen areas x 100.

4. Number of Participants With Plaque Protrusion and Thrombus [During procedure, an average of 1 hour]

   Plaque protrusion and thrombus is defined as a mass attached to the luminal surface or floating within the lumen, meeting the following criteria: Protrusion is defined as any mass at least 0.2 mm beyond the luminal edge of a strut and will be further classified as Major and Minor. Major: Protrusion area/Stent area at site of tissue protrusion ≥10% Minor: Protrusion area/Stent area at site of tissue protrusion<10%

5. Number of Participants With Untreated Reference Segment Disease [During procedure, an average of 1 hour]

   Untreated reference segment disease is defined as untreated Mean Lumen Area (MLA) ≤60% of the adjacent reference segment lumen area up to 10 mm from the proximal and distal stent edges.

6. Number of Participants With Edge Dissections [During procedure, an average of 1 hour]

   Edge Dissections are classified as A) Major (%): ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length B) Minor (%): any visible edge dissection <60 degrees of the circumference of the vessel and < 3 mm in length C) All (Major and Minor) Edge dissections will be further classified as: I. Intimal (limited to the intima layer, i.e. not extending beyond the internal elastic lamina) II. Medial (extending into the media layer) III. Adventitial (extending through the external elastic membrane

7. Number of Participants With Stent Malapposition [During procedure, an average of 1 hour]

   Frequency (%) of incompletely apposed stent struts (defined as stent struts clearly separated from the vessel wall (lumen border/plaque surface) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch). Malapposition will be further classified as: Major: if associated with unacceptable stent expansion Minor: if not associated with significant under-expansion

8. Number of Participants With Border Detection (OCT Arm Only) [Pre-PCI OCT Run procedure]

   The visibility of the vessel external elastic lamina (EEL) border by OCT will be evaluated at both reference sites (proximal and distal) and the MSA before AND after intervention and then classified into 3 grades: A) Good: ≥75% (270°) of visible circumference B) Moderate: ≥50% (180°) - <75% (270°) of visible circumference C) Poor: <50% (180°) of visible circumference

9. Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run [During procedure, an average of 1 hour]

   Clinical decision making will be assessed on the basis of the post-stent imaging run

10. Median Intra-stent Lumen Area (Intra-stent Flow Area) [Up to 1 hour post-procedure]

    Intra-stent Lumen Area (Intra-stent Flow Area) is defined as stent area minus any protrusion

11. Median Effective Lumen Area (Total Flow Area) [Up to 1 hour post-procedure]

    Effective lumen area (Total flow area) is defined as Intra-stent Lumen Area plus any area of malapposition between the stent and the vessel wall (lumen border/plaque border).

12. IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) [During procedure, an average of 1 hour]

    Dissection (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts

13. IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) [During procedure, an average of 1 hour]

    Malapposition (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts

14. IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) [During procedure, an average of 1 hour]

    Protrusion (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts

15. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter [Baseline]

    Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter

16. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter [Final Post-PCI, up to 1 hour after PCI procedure]

    Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter

17. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis [Baseline]

    Angiographic Endpoints (QCA) will be assessed as diameter stenosis

18. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis [Final Post-PCI, up to 1 hour after PCI procedure]

    Angiographic Endpoints (QCA) will be assessed as diameter stenosis

19. Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention [Final Post-PCI, up to 1 hour after PCI procedure]

    Angiographic Endpoints (QCA) will be assessed as Acute lumen gain post-intervention

20. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio [Baseline]

    Angiographic Endpoints (QCA) will be assessed as Maximum stent size/reference vessel diameter ratio. Maximum stent size refers to the largest stent diameter used in a treated segment. If only one stent was used, it is that stent diameter. If more than one stent were used, it is the larger of the stent diameters.

21. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio [Final Post-PCI, up to 1 hour after PCI procedure]

    Angiographic Endpoints (QCA) will be assessed as Maximum stent size/reference vessel diameter ratio. Maximum stent size refers to the largest stent diameter used in a treated segment. If only one stent was used, it is that stent diameter. If more than one stent were used, it is the larger of the stent diameters.

22. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B [Final Post-PCI, up to 1 hour after PCI procedure]

    Angiographic Endpoints (QCA) will be assessed as Angiographic dissection ≥ NHLBI type B

23. Procedural Endpoints (Site Reported): Median Total Stent Length [During procedure, an average of 1 hour]

    Median Total Stent Length will be measured in millimeters.

24. Procedural Endpoints (Site Reported): Median Stents Per Lesion [During procedure, an average of 1 hour]

    Median Stents per lesion will be measured in counts

25. Procedural Endpoints (Site Reported) - Median Maximal Stent Size [During procedure, an average of 1 hour]

    Median Maximal stent size will be measured in millimeters.

26. Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations [During procedure, an average of 1 hour]

    Post dilatation inflations will be assessed in terms of use of balloon inflations

27. Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.) [During procedure, an average of 1 hour]

    Median Maximum inflation pressure will be measured in atm.

28. Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions [During procedure, an average of 1 hour]

    Participants will be analyzed for the use of additional inventions Additional interventions used on the basis of the post stent imaging run will be either use of Larger Balloon, Use of Higher Inflation Pressures, Use of Additional Inflations, Use of Additional Stent(s), Thrombus Aspiration, or Other Interventions

29. Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate [During procedure, an average of 1 hour]

    Angiography defined procedural success rate is defined as a final lesion angiographic diameter stenosis <30% (QCA) and TIMI III flow (QCA) without dissection ≥ NHLBI type C, perforation, prolonged chest pain or ST segment elevation or depression changes (>30 minutes), or procedural death.

30. Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate [During procedure, an average of 1 hour]

    Device success rate (site reported): Successful OCT or IVUS imaging obtained pre and post PCI in the respective arms (does not include blinded OCT runs in the IVUS and Angiography arms)

31. Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF) [1 year]

    Target Lesion Failure (TLF) at 1 year defined as cardiovascular death, target vessel myocardial infarction, or ischemia driven target-lesion revascularization. Target lesion is defined as the lesion designated for randomization to OCT vs. IVUS vs. Angiography.

32. Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction [1 Year]

    Number of Participants With Periprocedural Myocardial Infarction will be assessed at 1 year

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

General Inclusion Criteria:

1. Age ≥ 18 years.

2. Patient with an indication for PCI including:

• Angina (stable or unstable),

• Silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present),

• NSTEMI, or

• Recent STEMI (>24 hours from initial presentation and stable).

1. Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES)

2. Signed written informed consent

Angiographic inclusion criteria:

1. The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of ≥2.25 mm to ≤3.50 mm.

2. Lesion length <40mm

General Exclusion Criteria:

1. Estimated creatinine clearance <30 ml/min using Cockcroft-Gault equation, unless the patient is on dialysis

2. STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital.

3. PCI within 24 hours preceding the study procedure.

4. PCI of a lesion within the target vessel within 12 months prior to the study procedure

5. Planned use of bare metal stent (BMS)

6. Planned use of bioresorbable vascular scaffold (BVS)

7. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP, at time of procedure.

8. Mobitz II second degree or complete heart block

9. Malignant ventricular arrhythmias requiring treatment

10. Pulmonary edema defined as patient with shortness of breath, evidence of volume overload on physical exam, and crepitations on physical exam (>1/3 of lungs) or radiographic interstitial or alveolar pulmonary edema

11. Subject is intubated.

12. Known LVEF <30%.

13. Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)

14. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA.

15. Presence of one or more co-morbidities which reduces life expectancy to less than 12 months or may interfere with protocol study processes.

16. Known allergy to protocol-required concomitant medications including aspirin; clopidogrel, prasugrel, and ticagrelor; heparin and bivalirudin; or iodinated contrast that cannot be adequately pre-medicated.

17. Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.

18. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before treatment).

Angiographic Exclusion Criteria:

1. The presence of any non-study lesion in the target vessel with angiographic diameter stenosis >50%, or any additional target vessel stenosis which requires PCI either during or within 12 months after the study procedure

2. Left main diameter stenosis ≥30% or left main PCI planned.

3. Study target lesion in a bypass graft

4. Ostial RCA study target lesion

5. Chronic total occlusion (TIMI flow 0/1) study target lesion

6. Bifurcation study lesion with a planned dual stent strategy

7. In-stent restenosis study target lesion

8. Any study lesion characteristic resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre and post PCI (e.g. moderate or severe vessel calcification or tortuosity)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital - Univ. of Alabama at Birmingham (UAB)	Birmingham	Alabama	United States	35249
2	Scottsdale Healthcare Shea	Scottsdale	Arizona	United States	85260
3	University of California at San Diego (UCSD) Medical Center	San Diego	California	United States	92037
4	Heart Institute of Colorado	Broomfield	Colorado	United States	80021
5	Orlando Health	Orlando	Florida	United States	32806
6	Emory University Hospital	Atlanta	Georgia	United States	30322
7	Kansas University Medical Center	Kansas City	Kansas	United States	66160
8	University of Massachusetts Medical Center	Worcester	Massachusetts	United States	01655
9	New York Presbyterian Hospital/Columbia University	New York	New York	United States	10032
10	Lenox Hill Hospital	New York	New York	United States	10075
11	St. Francis Hospital	Roslyn	New York	United States	11576
12	Eastern Cardiology	Greenville	North Carolina	United States	27834
13	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma	United States	73112
14	St. Charles Medical Center	Bend	Oregon	United States	97701
15	Austin Heart	Austin	Texas	United States	78705
16	Memorial Hermann Hospital	Houston	Texas	United States	77030
17	The University of Texas Health Science at San Antonio	San Antonio	Texas	United States	78229
18	Onze-Lieve-Vrouwziekenhuis Campus Aalst	Aalst	East Flanders	Belgium	9300
19	Klinikum der Justus-Liebig-Universität	Giessen	Hesse	Germany	35392
20	Ospedale Papa Giovanni XXIII	Bergamo	Lombardy	Italy	24127
21	Centro Cardiologico Monzino	Milan	Lombardy	Italy	20138
22	Kobe University Hospital	Chuo-ku	Hyogo	Japan	650-0017
23	Nara Medical University Hospital	Kashihara-shi	Nara	Japan	634-8521
24	Osaka Saiseikai Nakatsu Hospital	Osaka-shi	Osaka	Japan	530-0012
25	Wakayama Medical University Hospital	Wakayama City	Wakayama	Japan	641-8510
26	Yamaguchi University Hospital	Ube-shi	Yamaguchi	Japan	755-0046
27	Erasmus MC - Thoraxcenter	Rotterdam	Zuid-Holland	Netherlands	3015 CE
28	Hospital Universitario de la Princesa	Madrid		Spain	28006
29	Kings College Hospital	Brixton	London	United Kingdom	SE5 9RS

Sponsors and Collaborators

• Abbott Medical Devices
• Cardiovascular Research Foundation, New York

Investigators

• Principal Investigator: Ziad Ali, MD, Columbia Presbyterian Medical Center (NY)
• Study Chair: Gregg W Stone, MD, Columbia Presbyterian Medical Center (NY)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02471586
• Other Study ID Numbers: SJM-CIP-10034
• First Posted: Jun 15, 2015
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Keywords provided by Abbott Medical Devices: Percutaneous Coronary Intervention; Intravascular Ultrasound; Optical Coherence Tomography; SJM-CIP-10034
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Recruitment Details

A total of 1,759 subjects were initially consented, however only 450 subjects were actually randomized and enrolled into the trial across 29 sites. The first randomized subject was enrolled on May 13, 2015, and the last randomized subject was enrolled on April 5, 2016. Each site was allowed to enroll a maximum of 65 subjects in the trial. The subjects were followed through 12-months and the last subject follow-up visit was completed on April 25, 2017.

Pre-assignment Detail

Of the 1759 subjects consented, 1309 subjects were not randomized due to failed screening (n=1230), roll-in subjects (n=74), withdrawal of consent (n=1), withdrawal by the investigator (n=3) and software malfunction (n=1).

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Period Title: Overall Study
STARTED	158	146	146
COMPLETED	153	136	142
NOT COMPLETED	5	10	4

Baseline Characteristics

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography	Total
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type	Total of all reporting groups
Overall Participants	158	146	146	450
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.5 (9.3)	65.8 (9.5)	65.4 (11.2)	65.6 (10.0)
Sex: Female, Male (Count of Participants)
Female	49 31%	39 26.7%	39 26.7%	127 28.2%
Male	109 69%	107 73.3%	107 73.3%	323 71.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Netherlands	3 1.9%	2 1.4%	1 0.7%	6 1.3%
Belgium	1 0.6%	2 1.4%	1 0.7%	4 0.9%
United States	89 56.3%	81 55.5%	85 58.2%	255 56.7%
Japan	16 10.1%	15 10.3%	13 8.9%	44 9.8%
Italy	32 20.3%	31 21.2%	32 21.9%	95 21.1%
United Kingdom	4 2.5%	4 2.7%	3 2.1%	11 2.4%
Germany	4 2.5%	3 2.1%	3 2.1%	10 2.2%
Spain	9 5.7%	8 5.5%	8 5.5%	25 5.6%

Outcome Measures

1. Primary Outcome

Title	Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA)
Description	Post-PCI MSA will be assessed by OCT in each randomized arm, measured at the independent OCT core laboratory blinded to imaging modality assignment. Hierarchal manner testing will be as follows: Non-inferiority: OCT vs. IVUS guided stenting Non-inferiority of OCT guided stenting to IVUS guided stenting will be analyzed for the mean difference between the post PCI MSA for the OCT and IVUS arms with non-inferiority margin of 1.0 mm^2. Superiority: OCT vs. Angiography guided stenting If the OCT guided stenting arm was found to be non-inferior to the IVUS guided stenting arm, the superiority of OCT to angiography will be tested for the mean difference between the post PCI MSA for the OCT and angiography arms. Superiority: OCT vs. IVUS guided stenting If the OCT guided stenting arm was found to be superior to the IVUS guided stenting arm, then the superiority of OCT to IVUS will be tested for the mean difference between the post PCI MSA for the OCT and IVUS arms.
Time Frame	Post-procedure within 1 hour

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	140	135	140
Median (Inter-Quartile Range) [mm^2]	5.79	5.89	5.49

2. Primary Outcome

Title	Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event)
Description	Procedural MACE defined as procedural complications (angiographic dissection, perforation, thrombus, and acute closure) requiring active interventions (prolonged balloon inflations, additional stent implantations, pericardiocentesis, thrombus aspiration and other).
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Intra-Procedural Complications Required Active Interventions	4 2.5%	1 0.7%	1 0.7%
Prolonged Balloon Inflations	0 0%	0 0%	0 0%
Additional Stent implantation	4 2.5%	1 0.7%	1 0.7%
Pericardiocentesis	0 0%	0 0%	0 0%
Thrombus Aspiration	0 0%	0 0%	0 0%
Other Interventions	0 0%	0 0%	0 0%

3. Secondary Outcome

Title	Number of Participants With Acute Procedural Success
Description	Acute procedural success are classified as: A) Optimal (%) The MSA of the proximal segment is ≥95% of the proximal reference lumen area and the MSA of the distal segment is ≥95% of the distal reference lumen area. B) Acceptable (%) The MSA of the proximal segment is ≥90% and <95% of the proximal reference lumen area and the MSA of the distal segment is ≥90% and <95% of the distal reference lumen area. C) Optimal and Acceptable (%) The MSA of the proximal segment is ≥90% and <95% of the proximal reference lumen area and the MSA of the distal segment is ≥90% and <95% of the distal reference lumen area. D) Unacceptable (%) The MSA of the proximal segment is <90% of the proximal lumen area, and/or the MSA of the distal segment is <90% of the distal reference lumen area.
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	140	135	140
Optimal (≥95%)	36 22.8%	32 21.9%	23 15.8%
Acceptable (90 to 95%)	22 13.9%	16 11%	5 3.4%
Unacceptable (<90%)	82 51.9%	82 56.2%	108 74%

4. Secondary Outcome

Title	Rate of Post-PCI Stent Expansion (%)
Description	Post-PCI stent expansion is defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100.
Time Frame	Up to 1 hour post-procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	140	135	140
Mean (Standard Deviation) [percentage of stent expansion]	87.6 (16.6)	86.5 (15.9)	82.9 (12.9)

5. Secondary Outcome

Title	Rate of Mean Stent Expansion (%)
Description	Mean stent expansion is defined as the mean stent area (stent volume/analyzed stent length) divided by the average of proximal and distal reference lumen areas x 100.
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	140	135	140
Median (Inter-Quartile Range) [percentage of mean stent expansion]	105.8	106.3	101.4

6. Secondary Outcome

Title	Number of Participants With Plaque Protrusion and Thrombus
Description	Plaque protrusion and thrombus is defined as a mass attached to the luminal surface or floating within the lumen, meeting the following criteria: Protrusion is defined as any mass at least 0.2 mm beyond the luminal edge of a strut and will be further classified as Major and Minor. Major: Protrusion area/Stent area at site of tissue protrusion ≥10% Minor: Protrusion area/Stent area at site of tissue protrusion<10%
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	140	135	140
Major	27 17.1%	27 18.5%	25 17.1%
Minor	67 42.4%	73 50%	70 47.9%

7. Secondary Outcome

Title	Number of Participants With Untreated Reference Segment Disease
Description	Untreated reference segment disease is defined as untreated Mean Lumen Area (MLA) ≤60% of the adjacent reference segment lumen area up to 10 mm from the proximal and distal stent edges.
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	140	135	140
Count of Participants [Participants]	44 27.8%	45 30.8%	39 26.7%

8. Secondary Outcome

Title	Number of Participants With Edge Dissections
Description	Edge Dissections are classified as A) Major (%): ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length B) Minor (%): any visible edge dissection <60 degrees of the circumference of the vessel and < 3 mm in length C) All (Major and Minor) Edge dissections will be further classified as: I. Intimal (limited to the intima layer, i.e. not extending beyond the internal elastic lamina) II. Medial (extending into the media layer) III. Adventitial (extending through the external elastic membrane
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	140	135	140
Major	19 12%	35 24%	26 17.8%
Minor	20 12.7%	18 12.3%	35 24%
All (Major and Minor)	39 24.7%	53 36.3%	61 41.8%
Intimal	16 10.1%	11 7.5%	21 14.4%
Medial	27 17.1%	45 30.8%	40 27.4%
Adventitial	1 0.6%	0 0%	0 0%

9. Secondary Outcome

Title	Number of Participants With Stent Malapposition
Description	Frequency (%) of incompletely apposed stent struts (defined as stent struts clearly separated from the vessel wall (lumen border/plaque surface) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch). Malapposition will be further classified as: Major: if associated with unacceptable stent expansion Minor: if not associated with significant under-expansion
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	140	135	140
Major	15 9.5%	28 19.2%	44 30.1%
Minor	43 27.2%	24 16.4%	39 26.7%
All (Major and Minor)	58 36.7%	52 35.6%	83 56.8%

10. Secondary Outcome

Title	Number of Participants With Border Detection (OCT Arm Only)
Description	The visibility of the vessel external elastic lamina (EEL) border by OCT will be evaluated at both reference sites (proximal and distal) and the MSA before AND after intervention and then classified into 3 grades: A) Good: ≥75% (270°) of visible circumference B) Moderate: ≥50% (180°) - <75% (270°) of visible circumference C) Poor: <50% (180°) of visible circumference
Time Frame	Pre-PCI OCT Run procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention =Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice.IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS:Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography:Imaging type
Measure Participants	144	0	0
Poor <180º of Visible EEL Circumference	7 4.4%	0 0%	0 0%
Moderate >=1800, <2700 of Visible EEL Circumference	28 17.7%	0 0%	0 0%
Good >=2700 of Visible EEL Circumference	109 69%	0 0%	0 0%

11. Secondary Outcome

Title	Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run
Description	Clinical decision making will be assessed on the basis of the post-stent imaging run
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	150	140	0
OCT/IVUS Result Acceptable (Yes)	53 33.5%	78 53.4%	0 0%
OCT/IVUS Result Acceptable (No)	97 61.4%	62 42.5%	0 0%

12. Secondary Outcome

Title	Median Intra-stent Lumen Area (Intra-stent Flow Area)
Description	Intra-stent Lumen Area (Intra-stent Flow Area) is defined as stent area minus any protrusion
Time Frame	Up to 1 hour post-procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	140	135	140
Median (Inter-Quartile Range) [mm^2]	5.54	5.71	5.42

13. Secondary Outcome

Title	Median Effective Lumen Area (Total Flow Area)
Description	Effective lumen area (Total flow area) is defined as Intra-stent Lumen Area plus any area of malapposition between the stent and the vessel wall (lumen border/plaque border).
Time Frame	Up to 1 hour post-procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	140	135	140
Median (Inter-Quartile Range) [mm^2]	5.68	5.87	5.52

14. Secondary Outcome

Title	IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only)
Description	Dissection (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	135	140	0
Major	35 22.2%	15 10.3%	0 0%
Minor	18 11.4%	7 4.8%	0 0%
All (Major and Minor)	53 33.5%	22 15.1%	0 0%

15. Secondary Outcome

Title	IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only)
Description	Malapposition (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	135	140	0
Major	28 17.7%	20 13.7%	0 0%
Minor	24 15.2%	7 4.8%	0 0%
All (Major and Minor)	52 32.9%	27 18.5%	0 0%

16. Secondary Outcome

Title	IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only)
Description	Protrusion (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	135	140	0
Major	27 17.1%	10 6.8%	0 0%
Minor	73 46.2%	17 11.6%	0 0%
All (Major and Minor)	100 63.3%	27 18.5%	0 0%

17. Secondary Outcome

Title	Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter
Description	Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Median (Inter-Quartile Range) [mm]	0.99	1.03	0.95

18. Secondary Outcome

Title	Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter
Description	Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter
Time Frame	Final Post-PCI, up to 1 hour after PCI procedure

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
In-stent	2.71	2.78	2.71
In-segment	2.30	2.41	2.37

19. Secondary Outcome

Title	Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis
Description	Angiographic Endpoints (QCA) will be assessed as diameter stenosis
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Median (Inter-Quartile Range) [percentage of Diameter Stenosis]	64.1	63.7	66.0

20. Secondary Outcome

Title	Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis
Description	Angiographic Endpoints (QCA) will be assessed as diameter stenosis
Time Frame	Final Post-PCI, up to 1 hour after PCI procedure

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
In-stent	5.0	5.1	6.2
In-segment	14.7	13.4	13.0

21. Secondary Outcome

Title	Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention
Description	Angiographic Endpoints (QCA) will be assessed as Acute lumen gain post-intervention
Time Frame	Final Post-PCI, up to 1 hour after PCI procedure

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
In-stent	1.76	1.75	1.75
In-segment	1.32	1.38	1.36

22. Secondary Outcome

Title	Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio
Description	Angiographic Endpoints (QCA) will be assessed as Maximum stent size/reference vessel diameter ratio. Maximum stent size refers to the largest stent diameter used in a treated segment. If only one stent was used, it is that stent diameter. If more than one stent were used, it is the larger of the stent diameters.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Median (Inter-Quartile Range) [mm]	2.78	2.87	2.76

23. Secondary Outcome

Title	Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio
Description	Angiographic Endpoints (QCA) will be assessed as Maximum stent size/reference vessel diameter ratio. Maximum stent size refers to the largest stent diameter used in a treated segment. If only one stent was used, it is that stent diameter. If more than one stent were used, it is the larger of the stent diameters.
Time Frame	Final Post-PCI, up to 1 hour after PCI procedure

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Median (Inter-Quartile Range) [mm]	2.82	2.84	2.72

24. Secondary Outcome

Title	Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B
Description	Angiographic Endpoints (QCA) will be assessed as Angiographic dissection ≥ NHLBI type B
Time Frame	Final Post-PCI, up to 1 hour after PCI procedure

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Count of Participants [Participants]	1 0.6%	1 0.7%	1 0.7%

25. Secondary Outcome

Title	Procedural Endpoints (Site Reported): Median Total Stent Length
Description	Median Total Stent Length will be measured in millimeters.
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Median (Inter-Quartile Range) [mm]	23.5	24.0	20.0

26. Secondary Outcome

Title	Procedural Endpoints (Site Reported): Median Stents Per Lesion
Description	Median Stents per lesion will be measured in counts
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Median (Inter-Quartile Range) [Stents per lesion]	1	1	1

27. Secondary Outcome

Title	Procedural Endpoints (Site Reported) - Median Maximal Stent Size
Description	Median Maximal stent size will be measured in millimeters.
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Median (Inter-Quartile Range) [mm]	3.00	3.00	3.00

28. Secondary Outcome

Title	Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations
Description	Post dilatation inflations will be assessed in terms of use of balloon inflations
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Median (Inter-Quartile Range) [Number of inflations]	2	2	1

29. Secondary Outcome

Title	Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.)
Description	Median Maximum inflation pressure will be measured in atm.
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Median (Inter-Quartile Range) [atm]	18	20	18

30. Secondary Outcome

Title	Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions
Description	Participants will be analyzed for the use of additional inventions Additional interventions used on the basis of the post stent imaging run will be either use of Larger Balloon, Use of Higher Inflation Pressures, Use of Additional Inflations, Use of Additional Stent(s), Thrombus Aspiration, or Other Interventions
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	0
Larger Diameter Balloon	51 32.3%	28 19.2%	0 0%
Higher Pressure Balloon	57 36.1%	40 27.4%	0 0%
Additional Stent	11 7%	12 8.2%	0 0%
Other interventions	1 0.6%	1 0.7%	0 0%

31. Secondary Outcome

Title	Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate
Description	Angiography defined procedural success rate is defined as a final lesion angiographic diameter stenosis <30% (QCA) and TIMI III flow (QCA) without dissection ≥ NHLBI type C, perforation, prolonged chest pain or ST segment elevation or depression changes (>30 minutes), or procedural death.
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Count of Participants [Participants]	135 85.4%	130 89%	131 89.7%

32. Secondary Outcome

Title	Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate
Description	Device success rate (site reported): Successful OCT or IVUS imaging obtained pre and post PCI in the respective arms (does not include blinded OCT runs in the IVUS and Angiography arms)
Time Frame	During procedure, an average of 1 hour

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Count of Participants [Participants]	149 94.3%	139 95.2%	0 0%

33. Secondary Outcome

Title	Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF)
Description	Target Lesion Failure (TLF) at 1 year defined as cardiovascular death, target vessel myocardial infarction, or ischemia driven target-lesion revascularization. Target lesion is defined as the lesion designated for randomization to OCT vs. IVUS vs. Angiography.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	158	146	146
Count of Participants [Participants]	4 2.5%	6 4.1%	2 1.4%

34. Secondary Outcome

Title	Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction
Description	Number of Participants With Periprocedural Myocardial Infarction will be assessed at 1 year
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Coronary PCI Guided by OCT	Coronary PCI Guided by IVUS	Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Measure Participants	156	146	146
Count of Participants [Participants]	1 0.6%	1 0.7%	0 0%

Adverse Events

Time Frame	1 Year
Adverse Event Reporting Description	All-Cause Mortality and Serious Adverse Events were monitored and analyzed. Non-serious adverse event information was not monitored for this study.
Arm/Group Title	Coronary PCI Guided by OCT		Coronary PCI Guided by IVUS		Coronary PCI Guided by Angiography
Arm/Group Description	Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type		Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type		Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
All Cause Mortality
	Coronary PCI Guided by OCT		Coronary PCI Guided by IVUS		Coronary PCI Guided by Angiography
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/158 (1.3%)		2/146 (1.4%)		0/146 (0%)
Serious Adverse Events
	Coronary PCI Guided by OCT		Coronary PCI Guided by IVUS		Coronary PCI Guided by Angiography
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/158 (23.4%)		25/146 (17.1%)		26/146 (17.8%)
Blood and lymphatic system disorders
Bleeding	2/158 (1.3%)		0/146 (0%)		0/146 (0%)
Cardiac disorders
Coronary restenosis	0/158 (0%)		0/146 (0%)		1/146 (0.7%)
Unstable angina	2/158 (1.3%)		1/146 (0.7%)		1/146 (0.7%)
Coronary perforation	0/158 (0%)		1/146 (0.7%)		0/146 (0%)
Sustained ventricular tachycardia	0/158 (0%)		0/146 (0%)		1/146 (0.7%)
Chest pain	6/158 (3.8%)		4/146 (2.7%)		7/146 (4.8%)
Angina pectoris	1/158 (0.6%)		3/146 (2.1%)		1/146 (0.7%)
Myocardial ischemia	1/158 (0.6%)		0/146 (0%)		1/146 (0.7%)
Myocardial infarction	2/158 (1.3%)		0/146 (0%)		3/146 (2.1%)
Coronary artery occlusion	1/158 (0.6%)		0/146 (0%)		0/146 (0%)
Coronary artery disease	0/158 (0%)		1/146 (0.7%)		0/146 (0%)
Gastrointestinal disorders
Gastrointestinal bleeding	2/158 (1.3%)		2/146 (1.4%)		0/146 (0%)
Intestinal perforation	0/158 (0%)		0/146 (0%)		1/146 (0.7%)
Acute abdomen	0/158 (0%)		0/146 (0%)		1/146 (0.7%)
General disorders
Pain	0/158 (0%)		1/146 (0.7%)		1/146 (0.7%)
Hepatobiliary disorders
Cholecystitis	0/158 (0%)		1/146 (0.7%)		0/146 (0%)
Cholelithiasis	0/158 (0%)		1/146 (0.7%)		0/146 (0%)
Immune system disorders
Allergic drug reaction	0/158 (0%)		1/146 (0.7%)		0/146 (0%)
Infections and infestations
Pneumonia caused by Gram-Negative Bacilli	0/158 (0%)		1/146 (0.7%)		0/146 (0%)
Pneumonia caused by Haemophilus Influenzae	0/158 (0%)		0/146 (0%)		1/146 (0.7%)
Acute viral hepatitis	1/158 (0.6%)		0/146 (0%)		0/146 (0%)
Diverticulitis	0/158 (0%)		1/146 (0.7%)		0/146 (0%)
Sepsis	1/158 (0.6%)		1/146 (0.7%)		0/146 (0%)
Injury, poisoning and procedural complications
Overdose	1/158 (0.6%)		0/146 (0%)		0/146 (0%)
In-stent restenosis	1/158 (0.6%)		0/146 (0%)		0/146 (0%)
Trauma	1/158 (0.6%)		0/146 (0%)		0/146 (0%)
Investigations
Hyponatremia	0/158 (0%)		1/146 (0.7%)		0/146 (0%)
Elevated troponin	0/158 (0%)		1/146 (0.7%)		0/146 (0%)
Musculoskeletal and connective tissue disorders
Arm pain	1/158 (0.6%)		0/146 (0%)		0/146 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer	0/158 (0%)		0/146 (0%)		1/146 (0.7%)
Skin cancer	1/158 (0.6%)		0/146 (0%)		0/146 (0%)
Nodule	1/158 (0.6%)		0/146 (0%)		0/146 (0%)
Cancer	1/158 (0.6%)		0/146 (0%)		0/146 (0%)
Colon polyps	1/158 (0.6%)		0/146 (0%)		0/146 (0%)
Nervous system disorders
Seizure/convulsions/epilepsy	1/158 (0.6%)		0/146 (0%)		0/146 (0%)
Transient ischemic attack (TIA)	0/158 (0%)		0/146 (0%)		1/146 (0.7%)
Stroke	1/158 (0.6%)		1/146 (0.7%)		0/146 (0%)
Syncope	1/158 (0.6%)		1/146 (0.7%)		1/146 (0.7%)
Renal and urinary disorders
Urinary tract infections	0/158 (0%)		1/146 (0.7%)		0/146 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	3/158 (1.9%)		0/146 (0%)		2/146 (1.4%)
Vascular disorders
VASC vessel perforation	1/158 (0.6%)		0/146 (0%)		0/146 (0%)
Vascular dissection	0/158 (0%)		0/146 (0%)		1/146 (0.7%)
Vasc pseudoaneurysm	2/158 (1.3%)		0/146 (0%)		0/146 (0%)
Arterial hypertension/hypertension	0/158 (0%)		1/146 (0.7%)		0/146 (0%)
Left main dissection	1/158 (0.6%)		0/146 (0%)		0/146 (0%)
Hypotension	0/158 (0%)		0/146 (0%)		1/146 (0.7%)
Other (Not Including Serious) Adverse Events
	Coronary PCI Guided by OCT		Coronary PCI Guided by IVUS		Coronary PCI Guided by Angiography
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.