PREVENT: The Preventive Coronary Intervention on Stenosis With Functionally Insignificant Vulnerable Plaque

Sponsor

Seung-Jung Park (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02316886

Collaborator

CardioVascular Research Foundation, Korea (Other)

1,608

Enrollment

Locations

Arms

98.9

Anticipated Duration (Months)

89.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether preventive coronary intervention on functionally insignificant coronary stenosis with vulnerable plaque characteristics plus optimal medical therapy reduces the incidence of the composite of cardiovascular death, target vessel myocardial infarction, or ischemia driven target lesion revascularization compared with optimal medical therapy alone.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Plaque, Atherosclerotic	Device: Coronary intervention Drug: Optimal Medical treatment	Phase 4

Detailed Description

Sub-analysis for each imaging test will be performed as below ;

NIRS(Near-infrared spectroscopy)
OCT(Optical coherence tomography)
VH-IVUS(IVUS-derived virtual histology)
IVUS(Intravascular ultrasonography)

Study Design

Study Type:

Interventional

Actual Enrollment :

1608 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Preventive Coronary Intervention on Stenosis With Functionally Insignificant Stenosis With Vulnerable Plaque Characteristics

Actual Study Start Date :

Oct 5, 2015

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coronary intervention Bioresorbable Vascular Scaffold or Everolimus Eluting stent (EES) +Optimal Medical Treatment	Device: Coronary intervention Bioresorbable Vascular Scaffold or Everolimus Eluting stent (EES) +Optimal Medical Treatment
Active Comparator: Optimal Medical Treatment Optimal Medical Treatment	Drug: Optimal Medical treatment

Arm

Intervention/Treatment

Experimental: Coronary intervention

Bioresorbable Vascular Scaffold or Everolimus Eluting stent (EES) +Optimal Medical Treatment

Device: Coronary intervention

Bioresorbable Vascular Scaffold or Everolimus Eluting stent (EES) +Optimal Medical Treatment

Active Comparator: Optimal Medical Treatment

Optimal Medical Treatment

Drug: Optimal Medical treatment

Outcome Measures

Primary Outcome Measures

Target vessel failure [2 years]
Target vessel failure (TVF) is defined as a composite of cardiac death, target vessel related MI, ischemia-driven target vessel revascularization, or unplanned hospitalization for angina.

Secondary Outcome Measures

Major adverse cardiac event [2 years]
defined as cardiovascular death, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable angina
Target lesion failure, defined as a composite of cardiovascular death, target lesion related myocardial infarction, or target lesion revascularization [2 years]
Death from any causes [2 years]
The composite of death, myocardial infarction, and any repeat revascularization [2 years]
Cardiac death [2 years]
Cardiac death
Target vessel-related myocardial infarction [2 years]
Target vessel revascularization [2 years]
Cardiac death and combinations of cardiac death with other components of MACE [1 month]
Cardiac death and combinations of cardiac death with other components of MACE at each time point
Cardiac death and combinations of cardiac death with other components of MACE [6 months]
Cardiac death and combinations of cardiac death with other components of MACE at each time point
Cardiac death and combinations of cardiac death with other components of MACE [12 months]
Cardiac death and combinations of cardiac death with other components of MACE at each time point
Cardiac death and combinations of cardiac death with other components of MACE [2 years]
Cardiac death and combinations of cardiac death with other components of MACE at each time point
Non-urgent revascularization procedures [2 years]
Unplanned hospitalization for angina [2 years]
CCS(Canadian Cardiovascular Society) angina class [2 years]
Number of anti-anginal medication [1 month]
Number of anti-anginal medication at each point in time
Number of anti-anginal medication [6 months]
Number of anti-anginal medication at each point in time
Number of anti-anginal medication [12 months]
Number of anti-anginal medication at each point in time
Number of anti-anginal medication [2 years]
Number of anti-anginal medication at each point in time
Rate of non-urgent (repeat) revascularization [1 month]
Rate of non-urgent (repeat) revascularization at each point in time
Rate of non-urgent (repeat) revascularization [6 months]
Rate of non-urgent (repeat) revascularization at each point in time
Rate of non-urgent (repeat) revascularization [12 months]
Rate of non-urgent (repeat) revascularization at each point in time
Rate of non-urgent (repeat) revascularization [2-year]
Rate of non-urgent (repeat) revascularization at each point in time

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 years or older
Symptomatic or asymptomatic coronary artery disease patients
Patients having at least one significant stenosis (diameter stenosis > 50%) with FFR

0.80 and meeting two of the following:

MLA(minimal luminal area)<4mm2
plaque burden>70%
Lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy) (defined as maxLCBI4mm>315)
TCFA(thin-cap fibroatheroma) defined by OCT(fibrous cap thickness<65µm and arc>90°) or VH-IVUS≥10% confluent NC with>30° abutting to the lumen in 3 consecutive slices)

2 target vulnerable lesions
Eligible for percutaneous coronary intervention with Absorb Bioresorbable Vascular Scaffold or Everolimus Eluting Stent
Willing and able to provide informed written consent
Reference vessel diameter 2.75-4.0
Lesion length ≤ 40

Exclusion Criteria:

Patients in whom the preferred treatment is CABG(Coronary artery bypass grafting)
Stented lesion
Bypass graft lesion
The patients who have more than or equal to 3 target lesions
2 target lesions in the same coronary territory
Heavily calcified or angulated lesion
Bifurcation lesion requiring 2 stenting technique
Contraindication to or planned discontinuation of dual antiplatelet therapy within 1 year
Life expectancy less than 2 years
Planned cardiac surgery or planned major non cardiac surgery
Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States
2	Kyoto University Hospital	Kyoto		Japan
3	Asan Medical Center	Seoul	Songpa-gu	Korea, Republic of	138-736
4	Hallym University Sacred Heart Hospital	Anyang		Korea, Republic of
5	Gangwon National Univ. Hospital	Chuncheon		Korea, Republic of
6	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
7	Chungnam National University Hospital	Daejeon		Korea, Republic of
8	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon		Korea, Republic of
9	Chonnam National University Hospital	Gwangju		Korea, Republic of
10	Gachon University Gil Hospital	Incheon		Korea, Republic of
11	ChonBuk National University Hospital	Jeonju		Korea, Republic of
12	Samsung Medical Center	Seoul		Korea, Republic of
13	Seoul National University hospital	Seoul		Korea, Republic of
14	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul		Korea, Republic of
15	Bundang Cha Medical Center	Sŏngnam		Korea, Republic of
16	Seoul National University Bundang hospital	Sŏngnam		Korea, Republic of
17	Christchurch Hospital and Canterbury DHB, University of Otago	Christchurch		New Zealand
18	National Taiwan University Hospital	Taipei		Taiwan