PRESSUREwire Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02935088
• Collaborator: (none)
• Enrollment: 2,217
• Locations: 71
• Actual Duration (Months): 29.3
• Patients Per Site: 31.2
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Acute Coronary Syndrome	Device: Fractional Flow Reserve

Detailed Description

The purpose of this study is to understand routine use of FFR and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.

The study will also collect data on the routine use of coronary physiologic measurements such as adenosine-induced hyperemia FFR, FFR by contrast-induced hyperemia,

Study Design

• Study Type: Observational
• Actual Enrollment: 2217 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Practical Evaluation of Fractional Flow Reserve (FFR) and Its Associated Alternate Indices During Routine Clinical Procedures
• Actual Study Start Date: Oct 12, 2016
• Actual Primary Completion Date: Mar 22, 2019
• Actual Study Completion Date: Mar 22, 2019

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices [12 months]

   Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization. Fisher Exact test will be performed to evaluate the association between 12-month MACE event and binary FFR variables respectively using the following FFR; Low FFR group (FFR ≤ 0.8) and high FFR group (FFR > 0.8).

Other Outcome Measures

1. Correlation of Resting Indices With FFR Values [at time of procedure]

   Linear correlation will be used for continuous variables to examine agreement between FFR values and resting indices.

2. Number of Subjects Who Had a Change in Treatment Plan When FFR is Used Compared to the Initial Decision Based on Angiography Alone [at time of procedure]

   Treatment decision was defined as "changed" if there is at least one decision change based on FFR for multiple lesions; if none of the decisions was changed for the multiple lesions, the treatment decision is defined as "unchanged".

3. Number of Subjects With 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up Subjects in Whom the Use of FFR Did Not Lead to a Change in Treatment Decision vs Subjects in Whom the Use of FFR Led to a Change in Treatment Decision [12 months]

   Number of subjects with 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up subjects in whom the use of FFR did not lead to a change in treatment decision vs subjects in whom the use of FFR led to a change in treatment decision.

4. Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) [12 months]

   Number of subjects with 12-month clinical outcomes (MACE) by other PressureWire-derived indices (contrast FFR). Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization.

5. Correlation of Other PressureWire-derived Index, Contrast FFR With FFR Values [at time of procedure]

   Linear correlation of FFR and contrast FFR (cFFR). Only subjects that had both FFR and cFFR were used in the analysis.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patient is presenting with STEMI, NSTEMI, unstable angina, or stable coronary artery disease

• Patient is planned to have FFR performed or underwent a cardiac catheterization where FFR was performed for further PCI (Percutaneous Cardiac Intervention) consideration

• Patient signs and dates written informed consent

• Patient is eighteen years of age or older at the time of consent

Exclusion Criteria:

• Patient has extremely tortuous or calcified coronary arteries

• Patient with a patent coronary artery bypass graft to the target vessel

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center Research, LLC	Huntsville	Alabama	United States	35801
2	Orlando Health	Orlando	Florida	United States	32806
3	Atlanta VA Medical Center	Decatur	Georgia	United States	30033
4	Providence Everett Medical Center	Everett	Washington	United States	98206
5	Allgemeines Krankenhaus Linz	Linz		Austria	4020
6	Krankenhaus Lainz	Vienna		Austria
7	London Health Sciences Centre	London		Canada
8	Hopital Sacre Coeur	Montreal		Canada
9	Aswan Cardiac Center	Aswan		Egypt
10	Al Dorrah Heart Care Hospital	Cairo		Egypt
11	North Estonia Medical Centre	Tallinn		Estonia
12	Tartu University Hospital	Tartu		Estonia
13	Universitätsklinikum Aachen	Aachen		Germany
14	St.-Johannes-Hospital	Dortmund		Germany
15	Medizinische Einrichtungen der Universität Düsseldorf	Dusseldorf		Germany
16	Kliniken der Friedrich-Alexander-Universitat	Erlangen		Germany	91054
17	Kliniken Villingen-Schwenningen	Villingen-Schwenningen		Germany
18	Alexandra General Hospital	Athens		Greece
19	University Hospital of Ioannina	Ioannina		Greece
20	Postgraduate Institute of Medical Education & Research	Chandigarh		India
21	Apollo Hospital	Chennai		India
22	The Madras Medical Mission	Chennai		India
23	Medanta - The Medicity Hospital	Gurgaon		India
24	Fortis Escorts Hospital, Jaipur	Jaipur		India
25	Lisie Hospital	Kochi		India
26	Caritas Hospital	Kottayam		India
27	Sunshine Hospitals	Secunderabad		India
28	Ananthapuri Hospitals and Research Institute	Thiruvananthapuram		India
29	Sree Chitra Tirunal Institute for Medical Sciences and tech.	Trivandrum		India
30	Christian Medical College & Hospital	Vellore		India
31	Ospedale Maggiore-Bellaria	Bologna		Italy
32	Centro Cardiologico Monzino	Milano		Italy	20138
33	Policlinico di Modena	Modena		Italy
34	Azienda Ospedaliera Monaldi	Napoli		Italy
35	Policlinico Universitario A. Gemelli	Roma		Italy
36	Ospedale di Trento - P.O.Santa Chiara	Trento		Italy
37	Gifu Heart Center	Gifu-shi		Japan
38	Tokyo Medical University Hachioji Medical Center	Hachioji		Japan
39	Kansai Rosai Hospital	Hyogo		Japan
40	Tenyoukai Central Hospital	Kagoshima-shi		Japan
41	Yokosuka Kyosai Hospital	Kanagawa		Japan
42	Kanazawa Cardiovascular Hospital	Kanazawa		Japan
43	Gunma Prefectural Cardiovascular Center	Maebashi-shi		Japan
44	Nishinomiya Watanabe Cardiovascular Center	Nishinomiya-shi		Japan
45	Sapporo Cardiovascular Clinic	Sapporo-shi		Japan
46	Tohoku University Hospital	Sendai		Japan
47	Higashi Takarazuka Satoh Hospital	Takarazuka		Japan
48	Tsuchiura Kyodo General Hospital	Tsuchiura-shi		Japan
49	Yokohama City University Medical Center	Yokohama-shi		Japan
50	VU Amsterdam	Amsterdam		Netherlands	1081HV
51	Onze Lieve Vrouw Gasthuis	Amsterdam		Netherlands	1091 AC
52	Amphia Hospital	Breda		Netherlands
53	Haga Ziekenhuis Locatie Leyenburg	Den Haag		Netherlands	2545AA
54	Catharina Ziekenhuis	Eindhoven		Netherlands
55	Hospital Garcia de Orta, EPE	Almada		Portugal
56	Santa Maria Hospital	Lisboa		Portugal
57	Hospital do Divino Espírito Santo	Ponta Delgada		Portugal
58	Centro Hospitalar Vila Nova Gaia	Vila Nova de Gaia		Portugal
59	King Abdullah Medical City	Mecca		Saudi Arabia
60	King Khalid University Hospital	Riyadh		Saudi Arabia
61	Hospital de Basurto	Bilbao		Spain	48013
62	Hospital Asistencial Universitario de Burgos	Burgos		Spain	09006
63	Complejo Hospitalario de Jaen	Jaen		Spain	23007
64	Hospital Universitario Son Espases	Palma de Mallorca		Spain
65	Hospital Universitario Donostia	San Sebastian		Spain
66	Complejo Hospital Nuestra Señora de la Candelaria	Santa Cruz De Tenerife		Spain
67	Hospital Universitario Marqués de Valdecilla	Santander		Spain
68	Golden Jubilee National Hospital	Clydebank		United Kingdom
69	Kettering General Hospital	Kettering		United Kingdom
70	Royal Free Hospital	London		United Kingdom
71	St. Bartholomew's Hospital	London		United Kingdom

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Colin Berry, MD, University of Glasgow

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 1, 2016

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02935088
• Other Study ID Numbers: SJM-CIP-10136
• First Posted: Oct 17, 2016
• Last Update Posted: Feb 7, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Abbott Medical Devices: FFR; Percutaneous coronary intervention
• Additional relevant MeSH terms: Coronary Artery Disease; Acute Coronary Syndrome

Study Results

Participant Flow

Arm/Group Title	FFR-guided PCI Patients
Arm/Group Description	Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS) who is undergoing Fractional flow reserve (FFR)-guided percutaneous intervention (PCI) procedure
Period Title: Overall Study
STARTED	2217
COMPLETED	2115
NOT COMPLETED	102

Baseline Characteristics

Arm/Group Title	FFR-guided PCI Patients
Arm/Group Description	Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS) who are undergoing fractional flow reserve (FFR)-guided Percutaneous intervention (PCI)
Overall Participants	2217
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.5 (10.5)
Sex: Female, Male (Count of Participants)
Female	653 29.5%
Male	1564 70.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.1%
Asian	326 14.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	46 2.1%
White	1681 75.8%
More than one race	0 0%
Unknown or Not Reported	162 7.3%
Region of Enrollment (participants) [Number]
United States	250 11.3%
Japan	165 7.4%
Egypt	30 1.4%
United Kingdom	176 7.9%
Portugal	29 1.3%
Spain	43 1.9%
India	97 4.4%
Greece	26 1.2%
Saudi Arabia	56 2.5%
Canada	57 2.6%
Austria	39 1.8%
Netherlands	785 35.4%
Italy	138 6.2%
Germany	295 13.3%
Estonia	31 1.4%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices
Description	Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization. Fisher Exact test will be performed to evaluate the association between 12-month MACE event and binary FFR variables respectively using the following FFR; Low FFR group (FFR ≤ 0.8) and high FFR group (FFR > 0.8).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The denominators used in the calculations of adverse event rates will be determined according to the analysis population excluding subjects who are lost to follow-up through given time point without events.

Arm/Group Title	FFR <= 0.80	FFR > 0.8
Arm/Group Description	Patients who had an FFR <= 0.80	Patients who had an FFR > 0.80
Measure Participants	794	1394
MACE	50 2.3%	51 NaN
Death	19 0.9%	30 NaN
Myocardial infarction	20 0.9%	23 NaN
Urgent revascularization	23 1%	17 NaN

2. Other Pre-specified Outcome

Title	Correlation of Resting Indices With FFR Values
Description	Linear correlation will be used for continuous variables to examine agreement between FFR values and resting indices.
Time Frame	at time of procedure

Outcome Measure Data

Analysis Population Description

The number of participants and lesions analyzed were based on the number of participants underwent both FFR and Pd/Pa measurements for this Outcome Measure

Arm/Group Title	FFR-guided PCI Patients (Lesion Level)
Arm/Group Description	Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS). The analysis is performed on lesion level
Measure Participants	1990
Measure Lesion	2644
Number [correlation coefficient]	0.55

3. Other Pre-specified Outcome

Title	Number of Subjects Who Had a Change in Treatment Plan When FFR is Used Compared to the Initial Decision Based on Angiography Alone
Description	Treatment decision was defined as "changed" if there is at least one decision change based on FFR for multiple lesions; if none of the decisions was changed for the multiple lesions, the treatment decision is defined as "unchanged".
Time Frame	at time of procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided PCI Patients
Arm/Group Description	Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS)
Measure Participants	2196
Count of Participants [Participants]	763 34.4%

4. Other Pre-specified Outcome

Title	Number of Subjects With 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up Subjects in Whom the Use of FFR Did Not Lead to a Change in Treatment Decision vs Subjects in Whom the Use of FFR Led to a Change in Treatment Decision
Description	Number of subjects with 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up subjects in whom the use of FFR did not lead to a change in treatment decision vs subjects in whom the use of FFR led to a change in treatment decision.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The denominators used in the calculations of adverse event rates will be determined according to the analysis population excluding subjects who are lost to follow-up through given time point without events.

Arm/Group Title	Change in Treatment Plan Patients	No Change in Treatment Plan Patients
Arm/Group Description	The population who has a change in treatment plan post FFR	The population who has no change in treatment plan post FFR
Measure Participants	760	1428
MACE	33 1.5%	68 NaN
Death	16 0.7%	33 NaN
Myocardial infarction	10 0.5%	22 NaN
Urgent revascularization	14 0.6%	26 NaN

5. Other Pre-specified Outcome

Title	Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR)
Description	Number of subjects with 12-month clinical outcomes (MACE) by other PressureWire-derived indices (contrast FFR). Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The denominators used in the calculations of adverse event rates will be determined according to the analysis population excluding subjects who are lost to follow-up through given time point without events.

Arm/Group Title	Pd/Pa ≤ 0.92	Pd/Pa > 0.92
Arm/Group Description	Patients who had an Pd/Pa ≤ 0.92	Patients who had an Pd/Pa > 0.92
Measure Participants	320	1684
MACE	28 1.3%	67 NaN
Death	9 0.4%	35 NaN
Myocardial infarction	13 0.6%	20 NaN
Urgent revascularization	17 0.8%	21 NaN

6. Other Pre-specified Outcome

Title	Correlation of Other PressureWire-derived Index, Contrast FFR With FFR Values
Description	Linear correlation of FFR and contrast FFR (cFFR). Only subjects that had both FFR and cFFR were used in the analysis.
Time Frame	at time of procedure

Outcome Measure Data

Analysis Population Description

The number of participants and lesions analyzed were based on the number of participants underwent both FFR and cFFR measurements for this Outcome Measure

Arm/Group Title	FFR-guided PCI Patients
Arm/Group Description	Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS)
Measure Participants	496
Measure Lesion	659
Number [correlation coefficient]	0.77

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Arm/Group Title	FFR-guided PCI Patients
Arm/Group Description	Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS)
All Cause Mortality
	FFR-guided PCI Patients
	Affected / at Risk (%)	# Events
Total	50/2217 (2.3%)
Serious Adverse Events
	FFR-guided PCI Patients
	Affected / at Risk (%)	# Events
Total	107/2217 (4.8%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	3/2217 (0.1%)	3
Cardiac disorders
Cardiac disorders	71/2217 (3.2%)	71
Gastrointestinal disorders
Gastrointestinal disorders	4/2217 (0.2%)	4
General disorders
General disorders	10/2217 (0.5%)	10
Infections and infestations
Infections and infestations	4/2217 (0.2%)	4
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications	1/2217 (0%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	8/2217 (0.4%)	8
Nervous system disorders
Nervous system disorders	3/2217 (0.1%)	3
Renal and urinary disorders
Renal and urinary disorders	2/2217 (0.1%)	2
Respiratory, thoracic and mediastinal disorders
Pneumonia	5/2217 (0.2%)	5
Surgical and medical procedures
Acute Aneurysm Abdominalis	1/2217 (0%)	1
Vascular disorders
Vascular disorders	6/2217 (0.3%)	6
Other (Not Including Serious) Adverse Events
	FFR-guided PCI Patients
	Affected / at Risk (%)	# Events
Total	114/2217 (5.1%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	3/2217 (0.1%)	3
Cardiac disorders
Cardiac disorders	77/2217 (3.5%)	77
Gastrointestinal disorders
Gastrointestinal disorders	4/2217 (0.2%)	4
General disorders
General disorders	10/2217 (0.5%)	10
Infections and infestations
Infections and infestations	4/2217 (0.2%)	4
Injury, poisoning and procedural complications
Dissection	1/2217 (0%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	8/2217 (0.4%)	8
Nervous system disorders
Nervous system disorders	3/2217 (0.1%)	3
Renal and urinary disorders
Renal Failure	2/2217 (0.1%)	2
Respiratory, thoracic and mediastinal disorders
Pneumonia	5/2217 (0.2%)	5
Surgical and medical procedures
Acute Aneurysm Abdominalis	1/2217 (0%)	1
Vascular disorders
Vascular disorders	7/2217 (0.3%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.