Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold

Vulnerable Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02319733
• Other study ID #: 2013/498
• Status: Terminated
• Phase: N/A
• First received: December 14, 2014
• Last updated: February 11, 2017
• Start date: December 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Canisius-Wilhelmina Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Vulnerable Plaque

Intervention

Device:
• Bioresorbable vascular scaffold
Implantation of Bioresorbable vascular scaffold in vulnerable plaques

Locations

Country	Name	City	State
Netherlands	Canisuis Wilhelmina Hospital	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Canisius-Wilhelmina Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in plaque cumulative score of signs of vulnerability on CT		24 months
Primary	nominal change in percent necrotic core and thin-cap fibroatheroma at VH-IVUS		24 months