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

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ClinicalTrials.gov Identifier: NCT02316886

Recruitment Status : Recruiting

First Posted : December 15, 2014

Last Update Posted : December 19, 2020

See Contacts and Locations

Sponsor:

Collaborator:

CardioVascular Research Foundation, Korea

Information provided by (Responsible Party):

Seung-Jung Park, Asan Medical Center

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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1600 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 :	October 5, 2015
Estimated Primary Completion Date :	December 31, 2022
Estimated Study Completion Date :	December 31, 2022

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

Outcome Measures

Primary Outcome Measures :

Target vessel failure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 years ]
Death from any causes [ Time Frame: 2 years ]
The composite of death, myocardial infarction, and any repeat revascularization [ Time Frame: 2 years ]
Cardiac death [ Time Frame: 2 years ]
Cardiac death
Target vessel-related myocardial infarction [ Time Frame: 2 years ]
Target vessel revascularization [ Time Frame: 2 years ]
Cardiac death and combinations of cardiac death with other components of MACE [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 years ]
Cardiac death and combinations of cardiac death with other components of MACE at each time point
Non-urgent revascularization procedures [ Time Frame: 2 years ]
Unplanned hospitalization for angina [ Time Frame: 2 years ]
CCS(Canadian Cardiovascular Society) angina class [ Time Frame: 2 years ]
Number of anti-anginal medication [ Time Frame: 1 month ]
Number of anti-anginal medication at each point in time
Number of anti-anginal medication [ Time Frame: 6 months ]
Number of anti-anginal medication at each point in time
Number of anti-anginal medication [ Time Frame: 12 months ]
Number of anti-anginal medication at each point in time
Number of anti-anginal medication [ Time Frame: 2 years ]
Number of anti-anginal medication at each point in time
Rate of non-urgent (repeat) revascularization [ Time Frame: 1 month ]
Rate of non-urgent (repeat) revascularization at each point in time
Rate of non-urgent (repeat) revascularization [ Time Frame: 6 months ]
Rate of non-urgent (repeat) revascularization at each point in time
Rate of non-urgent (repeat) revascularization [ Time Frame: 12 months ]
Rate of non-urgent (repeat) revascularization at each point in time
Rate of non-urgent (repeat) revascularization [ Time Frame: 2-year ]
Rate of non-urgent (repeat) revascularization at each point in time

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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:
1. MLA(minimal luminal area)<4mm2
2. plaque burden>70%
3. Lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy) (defined as maxLCBI4mm>315)
4. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316886

Contacts

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Contact: Jung-Min Ahn, MD		drjmahn@gmail.com
Contact: Jung-Hee Ham, RN		cvcrc5@amc.seoul.kr

Locations

Show 35 study locations

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United States, California
Stanford University Medical Center	Withdrawn
Palo Alto, California, United States
United States, District of Columbia
Washington Hospital Center	Withdrawn
Washington, District of Columbia, United States
United States, Missouri
Saint Luke's Mid America Heart Institute	Withdrawn
Kansas City, Missouri, United States
United States, New York
Columbia University Medical Center	Not yet recruiting
New York, New York, United States
Contact: Gregg W Stone, MD gstone@crf.org
Principal Investigator: Gregg W Stone, MD
Australia, Victoria
Northern Hospital , Victoria Australia	Withdrawn
Epping, Victoria, Australia
Australia
Eastern Heart Clinic, Prince of Wales Hospital	Withdrawn
Randwick, Australia
China
Queen Elizabeth Hospital	Withdrawn
Hong Kong, China
Italy
EMO Centro Cuore Columbus, San Raffaele Hospital	Withdrawn
Milano, Italy
Japan
Aichi Medical University	Withdrawn
Aichi, Japan
Kawasaki Medical School	Withdrawn
Kurashiki, Japan
Kyoto University Hospital	Recruiting
Kyoto, Japan
Contact: Takeshi Kimura, MD taketaka@kuhp.kyoto-u.ac.jp
Principal Investigator: Takeshi Kimura, MD
Wakayama Medical University	Withdrawn
Wakayama, Japan
Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-736
Contact: Seung-jung Park, MD, PhD sjpark@amc.seoul.kr
Principal Investigator: Seung-jung Park, MD, PhD
Hallym University Sacred Heart Hospital	Recruiting
Anyang, Korea, Republic of
Contact: Hyun-Sook Kim, MD heartsk@hotmail.com
Principal Investigator: Hyun-Sook Kim, MD
Inje University Busan Paik Hospital	Withdrawn
Busan, Korea, Republic of
Gangwon National Univ. Hospital	Recruiting
Chuncheon, Korea, Republic of
Contact: Bong-Ki Lee, MD mdbklee@kangwon.ac.kr
Principal Investigator: Bong-Ki Lee, MD
Daegu Catholic University Medical Center	Withdrawn
Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center	Recruiting
Daegu, Korea, Republic of
Contact: Chang-Wook Nam, MD ncwcv@dsmc.or.kr
Principal Investigator: Chang-Wook Nam, MD
Chungnam National University Hospital	Recruiting
Daejeon, Korea, Republic of
Contact: Si-Wan Choi, MD siwanc@cnu.ac.kr
Principal Investigator: Si-wan Choi, MD
The Catholic University of Korea, Daejeon ST. Mary's Hospital	Completed
Daejeon, Korea, Republic of
Chonnam National University Hospital	Recruiting
Gwangju, Korea, Republic of
Contact: Young-Keun Ahn, MD cecilyk@chonnam.ac.kr
Principal Investigator: Young-Keun Ahn, MD
Gachon University Gil Hospital	Terminated
Incheon, Korea, Republic of
ChonBuk National University Hospital	Terminated
Jeonju, Korea, Republic of
Dong-A Medical Center	Withdrawn
Pusan, Korea, Republic of
Korea University Guro Hospital	Withdrawn
Seoul, Korea, Republic of
Samsung Medical Center	Terminated
Seoul, Korea, Republic of
Seoul National University hospital	Recruiting
Seoul, Korea, Republic of
Contact: Bon-Kwon Koo, MD bkkoo@snu.ac.kr
The Catholic University of Korea Seoul St. Mary's Hospital	Terminated
Seoul, Korea, Republic of
Ajou University Hospital	Withdrawn
Suwon, Korea, Republic of
Bundang Cha Medical Center	Recruiting
Sŏngnam, Korea, Republic of
Contact: Won-jang Kim, MD mdwjkim@gmail.com
Principal Investigator: Won-jang Kim, MD
Seoul National University Bundang hospital	Recruiting
Sŏngnam, Korea, Republic of
Contact: In-Ho Chae, MD ihchae@snu.ac.kr
Principal Investigator: In-Ho Chae, MD
Ulsan University Hospital	Withdrawn
Ulsan, Korea, Republic of
New Zealand
Christchurch Hospital and Canterbury DHB, University of Otago	Recruiting
Christchurch, New Zealand
Contact: David Smyth, MD david.smyth@cdhb.health.nz
Principal Investigator: David Smyth, MD
Singapore
National University Heart Center	Withdrawn
Singapore, Singapore
Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan
Contact: Paul Hsien Li Kao, MD hsienli_kao@yahoo.com
Principal Investigator: Paul Hsien Li Kao, MD

Sponsors and Collaborators

Seung-Jung Park

CardioVascular Research Foundation, Korea

Investigators

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Principal Investigator:	Gregg Stone, MD	Columbia University

More Information

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Responsible Party:	Seung-Jung Park, MD,PhD, Asan Medical Center
ClinicalTrials.gov Identifier:	NCT02316886
Other Study ID Numbers:	AMCCV2014-13
First Posted:	December 15, 2014 Key Record Dates
Last Update Posted:	December 19, 2020
Last Verified:	December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Seung-Jung Park, Asan Medical Center:


coronary intervention Vulnerable Plaque Insignificant Stenosis Bioresorbable Vascular Scaffold Everolimus Eluting stent

Additional relevant MeSH terms:

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Coronary Artery Disease Constriction, Pathologic Plaque, Atherosclerotic Coronary Disease Myocardial Ischemia Heart Diseases	Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathological Conditions, Anatomical

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