Safety and Efficacy of Everolimus - Eluting Bioresorbable Vascular Scaffold for Cardiac Allograft Vasculopathy

Universita di Verona34 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Azienda Ospedaliera Brotzu

Cagliari, Italy

Azienda Ospedaliera Specialistica Dei Colli

Naples, Italy

Azienda Ospedaliera Di Padova

Padua, Italy

Fondazione Irccs Policlinico San Matteo

Pavia, Italy

Azienda Ospedaliera San Camillo Forlanini

Rome, Italy

European Hospital

Rome, Italy

Azienda Sanitaria Universitaria Integrata Di Udine (Asuiud)

Udine, Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Cardialysis Core Laboratory For Imaging

Rotterdam, Netherlands

Thoraxcenter, Universtity of Rotterdam

Rotterdam, Netherlands

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)

Time frame: Basal procedure

Procedural success (subject based analysis)

Time frame: Basal procedure

Death (cardiac, vascular, non-cardiovascular)

Time frame: 30 days, 180 days, 2 years and 3 years

Myocardial infarction (MI: Q wave Myocardial Infarction (QMI)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Target lesion revascularization (TLR)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Target vessel revascularization (TVR)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Non-target vessel revascularization (NTVR)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Composite (Death/All MI/ Graft failure)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Composite (Cardiac death/TV-MI/TLR )

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Composite (Cardiac death/all MI/TLR )

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Composite (Cardiac death/all MI/TVR)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Composite (Death/All MI/all revascularization)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Scaffold thrombosis

Timing (Acute)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Scaffold thrombosis

Timing (Subacute)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Scaffold thrombosis

Timing (Late)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Scaffold thrombosis

Timing (Very late)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Scaffold thrombosis

Evidence (Definite)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Scaffold thrombosis

Evidence (Probable)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Scaffold thrombosis

Evidence (Possible)

Time frame: 30 days, 180 days, 1 year, 2 years and 3 years

Angiographic Endpoints

In-scaffold Reference Vessel Diameter (RVD) (mm)

Time frame: Basal procedure, 1 year and 3 years

Angiographic Endpoints

In-scaffold Minimal Lumen Diameter (MLD) (mm)

Time frame: Basal procedure, 1 year and 3 years

Angiographic Endpoints

In-scaffold Diameter Stenosis (DS) (%)

Time frame: Basal procedure, 1 year and 3 years

Angiographic Endpoints

In-scaffold late loss (mm)

Time frame: Basal procedure, 1 year and 3 years

Angiographic Endpoints

Proximal late loss (mm)

Time frame: Basal procedure, 1 year and 3 years

Angiographic Endpoints

Distal late loss (mm)

Time frame: Basal procedure, 1 year and 3 years

Angiographic Endpoints

In-scaffold absolute minimal luminal area (mm2)

Time frame: Basal procedure, 1 year and 3 years

Angiographic Endpoints

In-scaffold minimal luminal cross sectional area (mm2)

Time frame: Basal procedure, 1 year and 3 years

Angiographic Endpoints

In-segment late loss (mm) In-stent binary restenosis (%)

Time frame: Basal procedure, 1 year and 3 years

Angiographic Endpoints

In-segment binary restenosis

Time frame: Basal procedure, 1 year and 3 years

Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

Vessel (EEM) area (mm2)