The Preventive Coronary Intervention on Stenosis With Functionally Insignificant Vulnerable Plaque



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/10/2018
Start Date:October 2015
End Date:June 2019
Contact:Jung-Min Ahn, MD
Email:drjmahn@gmail.com

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

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.

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)

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
We found this trial at
5
sites
Palo Alto, California 94304
Principal Investigator: Alan C Yeung, MD
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185 Cooper Street
Epping, Victoria 3076
Principal Investigator: Peter Barlis, MD
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Kansas City, Missouri 64111
Principal Investigator: David J Cohen, MD
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Kansas City, MO
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Gregg W Stone, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Principal Investigator: Ron Waksman, MD
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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Washington,
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