Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold

NCT02319733 | Terminated

• 1 other identifier: 2013/498
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Bioresorbable vascular scaffold

EXPERIMENTAL

Implantation of Bioresorbable vascular scaffold in vulnerable plaques

Device: Bioresorbable vascular scaffold

Interventions

Bioresorbable vascular scaffold DEVICE

Implantation of Bioresorbable vascular scaffold in vulnerable plaques

Bioresorbable vascular scaffold

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Canisius-Wilhelmina Hospital: lead

Study Sites (1)

Canisuis Wilhelmina Hospital

Nijmegen, Gelderland, 6532 SZ, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr.

Study Record Dates

• First Submitted: December 14, 2014
• First Posted: December 18, 2014
• Study Start: December 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

NL (1)