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

NCT ID: NCT02377648

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-12-31

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

Conditions

Cardiac Allograft Vasculopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABSORB Bioresorbable Vascular Scaffold

Everolimus-Eluting Bioresorbable Vascular Scaffold implantation

Group Type: EXPERIMENTAL

Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB)

Intervention Type: DEVICE

Placement of bioresorbable vascular scaffold in 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.

Interventions

Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB)

Placement of bioresorbable vascular scaffold in 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Flavio Ribichini

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flavio L Ribichini, MD

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Michele Pighi, MD

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Locations

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

Countries

Italy; Netherlands

References

Ribichini F, Pighi M, Faggian G, Vassanelli C. Bioresorbable vascular scaffolds in cardiac allograft vasculopathy: a new therapeutic option. Am J Med. 2013 Nov;126(11):e11-4. doi: 10.1016/j.amjmed.2013.05.025. No abstract available.

Reference Type: BACKGROUND

PMID: 24157291 (View on PubMed)

Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

Reference Type: BACKGROUND

PMID: 25173339 (View on PubMed)

Taylor DO, Edwards LB, Aurora P, Christie JD, Dobbels F, Kirk R, Rahmel AO, Kucheryavaya AY, Hertz MI. Registry of the International Society for Heart and Lung Transplantation: twenty-fifth official adult heart transplant report--2008. J Heart Lung Transplant. 2008 Sep;27(9):943-56. doi: 10.1016/j.healun.2008.06.017. No abstract available.

Reference Type: BACKGROUND

PMID: 18765186 (View on PubMed)

Tomai F, Adorisio R, De Luca L, Pilati M, Petrolini A, Ghini AS, Parisi F, Pongiglione G, Gagliardi MG. Coronary plaque composition assessed by intravascular ultrasound virtual histology: association with long-term clinical outcomes after heart transplantation in young adult recipients. Catheter Cardiovasc Interv. 2014 Jan 1;83(1):70-7. doi: 10.1002/ccd.25054. Epub 2013 Jul 16.

Reference Type: BACKGROUND

PMID: 23765788 (View on PubMed)

Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hebert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009 Mar 14;373(9667):897-910. doi: 10.1016/S0140-6736(09)60325-1.

Reference Type: BACKGROUND

PMID: 19286089 (View on PubMed)

Pighi M, Tomai F, Petrolini A, de Luca L, Tarantini G, Barioli A, Colombo P, Klugmann S, Ferlini M, Ormezzano MF, Loi B, Calabro P, Bianchi RM, Faggian G, Forni A, Vassanelli C, Valgimigli M, Ribichini F. Everolimus-Eluting Bioresorbable Vascular Scaffold System in the Treatment of Cardiac Allograft Vasculopathy: the CART (Cardiac Allograft Reparative Therapy) Prospective Multicenter Pilot Study. J Cardiovasc Transl Res. 2016 Feb;9(1):40-8. doi: 10.1007/s12265-015-9665-x. Epub 2015 Dec 18.

Reference Type: DERIVED

PMID: 26684009 (View on PubMed)

Other Identifiers

CART

Identifier Type: -

Identifier Source: org_study_id