Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold

Canisius-Wilhelmina Hospital

Status

Terminated

Conditions

Vulnerable Plaque

Treatments

Device: Bioresorbable vascular scaffold

Study type

Interventional

Funder types

Other

Identifiers

NCT02319733

2013/498

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)