Everolimus-eluting Bioresorbable Vascular Scaffold System in the Treatment of Cardiac Allograft Vasculopathy in Heart Transplant Recipients: A Prospective Multicenter Pilot Study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Cardiac Allograft Vasculopathy
- Sponsor
- Universita di Verona
- Enrollment
- 34
- Locations
- 10
- Primary Endpoint
- Restenosis rate (bioresorbable vascular scaffold), defined as >50% narrowing at the stent site or 5 mm proximal or distal to the stent, as assessed by Quantitative Coronary Analysis.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The CART Pilot study was designed to provide preliminary observations (about performance and safety) and generate hypotheses for future studies . The primary goal of the study is to evaluate the performance at one year of second-generation ABSORB Bioresorbable Vascular Scaffold (BVS)(Abbott Vascular, Santa Clara, CA , USA), the Everolimus Eluting Bioresorbable Vascular Scaffold, in heart transplant recipients affected by cardiac allograft vasculopathy (CAV) and significative coronary stenosis.
The secondary objectives are:
- to collect data about the procedural and clinical outcomes post-procedure , 30 days, 180 days and at 1,2 and 3-year follow-up, of patients who underwent ABSORB BVS implantation in order to investigate the safety of the device in CAV population;
- to evaluate the progression of the disease and the its interactions with the study device by using data derived from multi-imaging invasive techniques.
The vascular reparative therapy and in particular the BVS technology showing important advantages in terms of endothelial preservation, adequate vasomotion, and restoration of the media and adventitia of the vessel wall, could represent a new and more effective therapeutic option, compared to bare-metal and drug-eluting stent technologies, for transplanted patients, since all these mechanisms may, at least in part, counteract the detrimental changes leading to CAV, namely constrictive remodeling and rapid atherosclerosis progression.
Subjects enrolled into the clinical study will be male or female derived from the heart transplant recipients population of every participating center. The clinical study will enroll 30 subjects. Subjects, who underwent the yearly expected coronary angiography follow-up after heart transplant surgery, meeting the general and angiographic inclusion and exclusion criteria (eligibility will be assessed by Heart Team consensus) will be asked to sign an informed consent form. Subjects who do not meet inclusion and exclusion criteria are subject to the standard follow-up of heart transplant (HTx) recipients and will undergo to an invasive evaluation after 365 ± 28 days.
The study comprises two distinct phases:
- the enrollment phase which starts with the recruitment of the first subject and it is planned to last one year;
- the follow-up phase which is planned to last three years from the enrollment of the last patient.
The total duration of the study will be of four years, including both the enrollment and the follow-up phases
Investigators
Flavio Ribichini
Medical Doctor
Universita di Verona
Eligibility Criteria
Inclusion Criteria
- •General Inclusion criteria:
- •All the enrolled patients must be heart transplanted recipients. The inclusion criteria must follow the most recent instructions for use (IFU) for BVS which may include but are not
- •Limited to the following:
- •Patient must be at least 18 years of age at the time of signing the Informed Consent Form
- •Patient must be eligible for percutaneous coronary intervention (PCI)
- •Patient is to be treated for de novo lesions located in previously untreated vessels.
- •Patient must agree to undergo all required follow-up visits and data collection.
- •Angiographic inclusion criteria:
- •Presence of at least one critical angiographic de novo lesion (DS ≥70%) or a non-critical angiographic de novo lesion (50% ≤ DS \<70%) associated with concomitant signs or symptoms of myocardial ischemia. Any intermediate lesion without a clear evidence of ischemia will be interrogated by means of fractional flow reserve assessment with a pressure wire, as recommended by current international guidelines
Exclusion Criteria
- •General Exclusion criteria:
- •Inability to obtain a signed informed consent from potential patient.
- •Contraindications for drug eluting scaffold implantation (known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, ticlopidine, prasugrel, and ticagrelor, everolimus, poly (L-lactide), poly (D,L-lactide), or platinum, or with contrast sensitivity, who cannot be adequately premedicated).
- •Female patients with childbearing potential with a positive pregnancy test within 7 days prior to the index procedure.
- •Prior Coronary Artery Bypass Graft (CABG) at any time or planned CABG.
Outcomes
Primary Outcomes
Restenosis rate (bioresorbable vascular scaffold), defined as >50% narrowing at the stent site or 5 mm proximal or distal to the stent, as assessed by Quantitative Coronary Analysis.
Time Frame: One Year
Secondary Outcomes
- Device success (lesion based analysis)(Basal procedure)
- Angiographic Endpoints(Basal procedure, 1 year and 3 years)
- Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints(Basal procedure and 3 years)
- Procedural success (subject based analysis)(Basal procedure)
- Death (cardiac, vascular, non-cardiovascular)(30 days, 180 days, 2 years and 3 years)
- Myocardial infarction (MI: Q wave Myocardial Infarction (QMI)(30 days, 180 days, 1 year, 2 years and 3 years)
- Target lesion revascularization (TLR)(30 days, 180 days, 1 year, 2 years and 3 years)
- Target vessel revascularization (TVR)(30 days, 180 days, 1 year, 2 years and 3 years)
- Non-target vessel revascularization (NTVR)(30 days, 180 days, 1 year, 2 years and 3 years)
- Composite (Death/All MI/ Graft failure)(30 days, 180 days, 1 year, 2 years and 3 years)
- Composite (Cardiac death/TV-MI/TLR )(30 days, 180 days, 1 year, 2 years and 3 years)
- Composite (Cardiac death/all MI/TLR )(30 days, 180 days, 1 year, 2 years and 3 years)
- Composite (Cardiac death/all MI/TVR)(30 days, 180 days, 1 year, 2 years and 3 years)
- Composite (Death/All MI/all revascularization)(30 days, 180 days, 1 year, 2 years and 3 years)
- Optical Coherence Tomography Endpoints(Basal procedure and 3 years)
- Scaffold thrombosis(30 days, 180 days, 1 year, 2 years and 3 years)