Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold

Plaque Stabilization and Restoration of Vascular Function by Bioresorbable Vascular Scaffold in Acute Coronary Syndrome Prone Patients

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.

Study Overview

• Status: Terminated
• Conditions: Vulnerable Plaque
• Intervention / Treatment: Device: Bioresorbable vascular scaffold

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6532 SZ
      • Canisuis Wilhelmina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bioresorbable vascular scaffold; Implantation of Bioresorbable vascular scaffold in vulnerable plaques	Device: Bioresorbable vascular scaffold; Implantation of Bioresorbable vascular scaffold in vulnerable plaques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Canisius-Wilhelmina Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: December 14, 2014
• First Submitted That Met QC Criteria: December 14, 2014
• First Posted (Estimate): December 18, 2014

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 11, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2013/498