RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

• Sponsor: Medtronic Vascular (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03584464
• Collaborator: (none)

Study Details

Study Description

Brief Summary

To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.

To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 205 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
• Actual Study Start Date: May 14, 2018
• Actual Primary Completion Date: Nov 4, 2020
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Bifurcation Cohort Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.	Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System; Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Target Vessel Failure (TVF) [12 Months]

   Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.

Secondary Outcome Measures

1. Number of Participants With Cardiac Death [12 months]

   Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.

2. Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI) [Up to 12 months]

   Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)

3. Number of Participants With Target Lesion Revascularization (TLR) [12 months]

   Target Lesion Revascularization (TLR) defined as repeat PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Surgery) to the target lesion, or clinically driven target lesion revascularization.

4. Number of Participants With Target Vessel Revascularization (TVR) [12 months]

   Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.

5. Number of Participants With Cardiac Death and TVMI [12 months]

   Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.

6. Number of Participants With Major Adverse Cardiac Event (MACE) [12 months]

   Major Adverse Cardiac Event (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically driven repeat target lesion revascularization by percutaneous or surgical methods.

7. Number of Participants With Target Lesion Failure (TLF) [12 months]

   Target Lesion Failure (TLF) defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods.

8. Number of Participants With Stent Thrombosis (ARC) Definite/Probable [12 months]

   Stent Thrombosis Definite/Probable defined per Academic Research Consortium (ARC). Definite: a. Angiographic confirmation of TIMI flow grade 0-3 and at least one of the following criteria within a 48 hour: 1.New onset s ischemic symptoms at rest (typical chest pain with duration >20 minutes); 2.New ischemic ECG changes suggestive of acute ischemia; 3.Typical rise and fall in cardiac biomarkers. or b. Pathologic confirmation of stent thrombosis: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable: Any unexplained death within the first 30 days.

Eligibility Criteria

Criteria

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

Key Inclusion Criteria

• Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarction

• Subject is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use, and the Declaration of Helsinki

• Subject requires treatment of a single de novo bifurcated lesion amenable to treatment with Resolute Onyx using the provisional stenting technique

Exclusion Criteria:

• Unprotected left main disease

• Subjects with planned PCI of three vessel disease

• Planned two stent technique (main branch and side branch) of a bifurcation

• Subjects with more than one bifurcation lesion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huntsville Hospital	Huntsville	Alabama	United States	35801-4421
2	Scripps Green Hospital	La Jolla	California	United States	92037
3	Riverside Community Hospital	Riverside	California	United States	92506-0102
4	Hartford Hospital	Hartford	Connecticut	United States	06106-5527
5	Morton Plant Hospital	Clearwater	Florida	United States	33756
6	North Florida Regional Medical Center	Gainesville	Florida	United States	32605-4524
7	Tallahassee Memorial Hospital	Tallahassee	Florida	United States	32308-4646
8	WellStar Kennestone Hospital	Marietta	Georgia	United States	30060-1125
9	University of Michigan Health System	Ann Arbor	Michigan	United States	48109-5869
10	Mercy Hospital	Coon Rapids	Minnesota	United States	55433-4568
11	Abbott Northwestern	Minneapolis	Minnesota	United States	55407-1195
12	Nebraska Medical Center	Omaha	Nebraska	United States	68198-2265
13	Desert Springs Hospital	Las Vegas	Nevada	United States	89118-3011
14	St. Josephs Hospital Health Center	East Syracuse	New York	United States	13057-9208
15	North Shore University Hospital	Manhasset	New York	United States	11030
16	NYU Langone Medical Center	New York	New York	United States	10016
17	New York-Presbyterian Hospital/ Columbia University Medical Center	New York	New York	United States	10032-3729
18	Baptist Memorial Hospital-Memphis	Germantown	Tennessee	United States	38138-1727
19	Houston Methodist Hospital	Houston	Texas	United States	77030
20	University of Virginia Medical Center	Charlottesville	Virginia	United States	22903
21	Saint Vincent Hospital	Green Bay	Wisconsin	United States	54301
22	CHU Charleroi	Charleroi		Belgium	6042
23	Ziekenhuis Oost Limburg	Genk		Belgium	3600
24	CHU Toulouse - Hôpital Rangueil	Toulouse		France	50032 31059
25	Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s	Banska Bystrica		Slovakia	97401

Sponsors and Collaborators

• Medtronic Vascular

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Dec 16, 2020
• Statistical Analysis Plan - Oct 10, 2021

More Information

Publications

None provided.

• Responsible Party: Medtronic Vascular
• ClinicalTrials.gov Identifier: NCT03584464
• Other Study ID Numbers: V 4.0 16Feb2018
• First Posted: Jul 12, 2018
• Last Update Posted: Apr 5, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Arm/Group Title	Bifurcation Cohort
Arm/Group Description	Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Period Title: Overall Study
STARTED	205
COMPLETED	204
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Bifurcation Cohort
Arm/Group Description	Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm in diameter for the treatment of a bifurcation lesion with provisional stenting.
Overall Participants	205
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	87 42.4%
>=65 years	118 57.6%
Sex: Female, Male (Count of Participants)
Female	44 21.5%
Male	161 78.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	12 5.9%
Not Hispanic or Latino	182 88.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	8 3.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	11 5.4%
White	159 77.6%
More than one race	15 7.3%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	167 81.5%
Europe	38 18.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Target Vessel Failure (TVF)
Description	Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bifurcation Cohort
Arm/Group Description	Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants	204
Count of Participants [Participants]	14 6.8%

2. Secondary Outcome

Title	Number of Participants With Cardiac Death
Description	Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bifurcation Cohort
Arm/Group Description	Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants	204
Count of Participants [Participants]	3 1.5%

3. Secondary Outcome

Title	Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)
Description	Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bifurcation Cohort
Arm/Group Description	Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants	204
Count of Participants [Participants]	6 2.9%

4. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Target Lesion Revascularization (TLR) defined as repeat PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Surgery) to the target lesion, or clinically driven target lesion revascularization.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bifurcation Cohort
Arm/Group Description	Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants	204
Count of Participants [Participants]	7 3.4%

5. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TVR)
Description	Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bifurcation Cohort
Arm/Group Description	Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants	204
Count of Participants [Participants]	8 3.9%

6. Secondary Outcome

Title	Number of Participants With Cardiac Death and TVMI
Description	Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bifurcation Cohort
Arm/Group Description	Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants	204
Count of Participants [Participants]	9 4.4%

7. Secondary Outcome

Title	Number of Participants With Major Adverse Cardiac Event (MACE)
Description	Major Adverse Cardiac Event (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically driven repeat target lesion revascularization by percutaneous or surgical methods.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bifurcation Cohort
Arm/Group Description	Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants	204
Count of Participants [Participants]	17 8.3%

8. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF)
Description	Target Lesion Failure (TLF) defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bifurcation Cohort
Arm/Group Description	Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants	204
Count of Participants [Participants]	13 6.3%

9. Secondary Outcome

Title	Number of Participants With Stent Thrombosis (ARC) Definite/Probable
Description	Stent Thrombosis Definite/Probable defined per Academic Research Consortium (ARC). Definite: a. Angiographic confirmation of TIMI flow grade 0-3 and at least one of the following criteria within a 48 hour: 1.New onset s ischemic symptoms at rest (typical chest pain with duration >20 minutes); 2.New ischemic ECG changes suggestive of acute ischemia; 3.Typical rise and fall in cardiac biomarkers. or b. Pathologic confirmation of stent thrombosis: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable: Any unexplained death within the first 30 days.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bifurcation Cohort
Arm/Group Description	Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Measure Participants	204
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	12 months
Arm/Group Title	Bifurcation Cohort
Arm/Group Description	Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
All Cause Mortality
	Bifurcation Cohort
	Affected / at Risk (%)	# Events
Total	6/205 (2.9%)
Serious Adverse Events
	Bifurcation Cohort
	Affected / at Risk (%)	# Events
Total	48/205 (23.4%)
Blood and lymphatic system disorders
Normocytic Anaemia	1/205 (0.5%)	1
Cardiac disorders
Acute Left Ventricular Failure	1/205 (0.5%)	1
Acute Myocardial Infarction	4/205 (2%)	4
Angina Pectoris	4/205 (2%)	4
Angina Unstable	1/205 (0.5%)	1
Atrial Fibrillation	2/205 (1%)	2
Atrioventricular Block Second Degree	1/205 (0.5%)	1
Bradycardia	1/205 (0.5%)	1
Cardiac Arrest	2/205 (1%)	2
Cardiac Failure Congestive	2/205 (1%)	3
Coronary Artery Disease	4/205 (2%)	4
Coronary Artery Dissection	1/205 (0.5%)	1
Sinus Arrest	1/205 (0.5%)	1
Gastrointestinal disorders
Diverticulum Intestinal	1/205 (0.5%)	1
Intestinal Obstruction	1/205 (0.5%)	2
Melaena	1/205 (0.5%)	2
Rectal Haemorrhage	1/205 (0.5%)	1
General disorders
Chest Pain	1/205 (0.5%)	1
Death	1/205 (0.5%)	1
Non-Cardiac Chest Pain	1/205 (0.5%)	1
Vascular Stent Stenosis	1/205 (0.5%)	1
Vessel Puncture Site Haematoma	1/205 (0.5%)	1
Immune system disorders
Drug Hypersensitivity	1/205 (0.5%)	1
Infections and infestations
Cellulitis	1/205 (0.5%)	1
Covid-19	1/205 (0.5%)	1
Gastroenteritis Viral	1/205 (0.5%)	1
Influenza	1/205 (0.5%)	1
Localised Infection	1/205 (0.5%)	1
Pneumonia	3/205 (1.5%)	3
Sepsis	2/205 (1%)	2
Septic Shock	1/205 (0.5%)	1
Injury, poisoning and procedural complications
Cardiac Procedure Complication	1/205 (0.5%)	1
Postoperative Respiratory Failure	1/205 (0.5%)	1
Procedural Pain	1/205 (0.5%)	1
Investigations
Myocardial Necrosis Marker Increased	3/205 (1.5%)	3
Musculoskeletal and connective tissue disorders
Back Pain	1/205 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer	1/205 (0.5%)	1
Rectal Adenocarcinoma	1/205 (0.5%)	1
Nervous system disorders
Carotid Artery Stenosis	1/205 (0.5%)	1
Cerebrovascular Accident	2/205 (1%)	2
Dizziness	1/205 (0.5%)	1
Paraesthesia	1/205 (0.5%)	1
Unresponsive To Stimuli	1/205 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure	1/205 (0.5%)	1
Chronic Obstructive Pulmonary Disease	1/205 (0.5%)	3
Dyspnoea	1/205 (0.5%)	1
Respiratory Failure	2/205 (1%)	2
Surgical and medical procedures
Carotid Endarterectomy	1/205 (0.5%)	1
Coronary Artery Bypass	1/205 (0.5%)	1
Vascular disorders
Haematoma	1/205 (0.5%)	1
Hypotension	1/205 (0.5%)	1
Peripheral Arterial Occlusive Disease	1/205 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Bifurcation Cohort
	Affected / at Risk (%)	# Events
Total	39/205 (19%)
Blood and lymphatic system disorders
Anaemia	2/205 (1%)	2
Blood Loss Anaemia	1/205 (0.5%)	1
Cardiac disorders
Angina Pectoris	1/205 (0.5%)	1
Bradycardia	1/205 (0.5%)	1
Bundle Branch Block Left	1/205 (0.5%)	1
Coronary Artery Disease	3/205 (1.5%)	3
Coronary Artery Dissection	2/205 (1%)	2
Coronary Artery Occlusion	1/205 (0.5%)	1
Left Ventricular Dysfunction	1/205 (0.5%)	1
Ventricular Tachycardia	1/205 (0.5%)	1
Gastrointestinal disorders
Gingival Bleeding	1/205 (0.5%)	1
Pneumoperitoneum	1/205 (0.5%)	1
General disorders
Chest Discomfort	1/205 (0.5%)	1
Chest Pain	2/205 (1%)	2
Injection Site Haemorrhage	1/205 (0.5%)	1
Malaise	1/205 (0.5%)	1
Vascular Stent Stenosis	2/205 (1%)	2
Infections and infestations
Urinary Tract Infection	1/205 (0.5%)	1
Injury, poisoning and procedural complications
Cardiac Procedure Complication	1/205 (0.5%)	1
Face Injury	1/205 (0.5%)	1
Patella Fracture	1/205 (0.5%)	1
Periprocedural Myocardial Infarction	1/205 (0.5%)	1
Plaque Shift	1/205 (0.5%)	1
Vascular Access Complication	1/205 (0.5%)	1
Vascular Access Site Swelling	1/205 (0.5%)	1
Investigations
Inflammatory Marker Increased	1/205 (0.5%)	1
Myocardial Necrosis Marker Increased	7/205 (3.4%)	7
Troponin I Increased	1/205 (0.5%)	1
Troponin Increased	3/205 (1.5%)	3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma	1/205 (0.5%)	1
Intraductal Proliferative Breast Lesion	1/205 (0.5%)	1
Nervous system disorders
Headache	1/205 (0.5%)	1
Paraesthesia	1/205 (0.5%)	1
Seizure	1/205 (0.5%)	1
Renal and urinary disorders
Nephrolithiasis	1/205 (0.5%)	1
Urinary Retention	1/205 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/205 (0.5%)	1
Vascular disorders
Labile Hypertension	1/205 (0.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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