Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold

NCT ID: NCT02319733

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-01-31

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.

Conditions

Vulnerable Plaque

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Bioresorbable vascular scaffold

Implantation of Bioresorbable vascular scaffold in vulnerable plaques

Group Type: EXPERIMENTAL

Bioresorbable vascular scaffold

Intervention Type: DEVICE

Implantation of Bioresorbable vascular scaffold in vulnerable plaques

Interventions

Bioresorbable vascular scaffold

Implantation of Bioresorbable vascular scaffold in vulnerable plaques

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canisius-Wilhelmina Hospital

OTHER

Sponsor Role: lead

Responsible Party

M.E.R. Gomes

dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Canisuis Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

2013/498

Identifier Type: -

Identifier Source: org_study_id