Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold

Not Applicable

Terminated

• Conditions: Vulnerable Plaque
• Interventions: Device: Bioresorbable vascular scaffold

• Registration Number: NCT02319733
• Lead Sponsor: Canisius-Wilhelmina Hospital

Brief Summary

The aim of the study is to assess if implantation of a bioresorbable vascular scaffold (BVS) for intermediate coronary lesions with morphological signs of vulnerable plaque in patients prone for acute coronary syndromes (ACS) will stabilize the plaque, improve natural vasomotion and increase vascular diameter.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-14
• Study First Submitted QC: 2014-12-14
• Study First Posted: 2014-12-18
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-11
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Symptomatic patients between the age of 18 and 80 years
• Morise Risk score of ≥9 (intermediate or high risk) but no proven ischemia (no positive troponin or ST-elevation)
• Intermediate coronary lesion on CT scan (50-70% based on CT estimate) and a plaque with at least two of the following vulnerability criteria: Napkin ring sign, positive remodeling, low attenuation and spotty calcification
• FFR negative lesion at coronary angiogram
• Vessel diameter ≥2.5 mm on visual estimate
• GFR ≥ 45mL/min/1.73m².

Exclusion Criteria

• High calcium score on CT scan preventing adequate evaluation of the coronary lesion.
• Lesions located in a coronary vessels previously stented.
• Lesions located at a bifurcation
• lesions involving an epicardial side branch ≥2 mm in diameter by visual assessment
• the presence of thrombus or another clinically significant stenosis in the target vessel.
• Left main (>50%) or known three vessel disease.
• Patients presenting with acute myocardial infarction, unstable arrhythmias, or patients who have a left ventricular ejection fraction <30%
• Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparine or Everolimus and known true anaphylaxis to prior contrast media or known bleeding diathesis or known coagulopathy.
• Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after inclusion.
• History of stent thrombosis
• Malignancies or other comorbidity with a life expectancy of less than one year or that may result in protocol noncompliance
• Pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bioresorbable vascular scaffold	Bioresorbable vascular scaffold	Implantation of Bioresorbable vascular scaffold in vulnerable plaques

Primary Outcome Measures

Name	Time	Method
change in plaque cumulative score of signs of vulnerability on CT	24 months
nominal change in percent necrotic core and thin-cap fibroatheroma at VH-IVUS	24 months

Trial Locations

Locations (1)

Canisuis Wilhelmina Hospital; 🇳🇱 Nijmegen, Gelderland, Netherlands