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

NCT02377648 | Completed Phase 4

• 1 other identifier: CART
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 10

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

Keywords

Cardiac Allograft Vasculopathy; Heart Transplant; Bioresorbable Vascular Scaffold

Outcome Measures

Primary Outcomes (1)

• 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.

  One Year

Secondary Outcomes (63)

• Device success (lesion based analysis)

  Basal procedure

• 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

Study Arms (1)

ABSORB Bioresorbable Vascular Scaffold

EXPERIMENTAL

Everolimus-Eluting Bioresorbable Vascular Scaffold implantation

Device: Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB)

Interventions

Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB) 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.

ABSORB Bioresorbable Vascular Scaffold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (10)

Azienda Ospedaliera Brotzu

Cagliari, Italy

Location

Azienda Ospedaliera Specialistica Dei Colli

Naples, Italy

Location

Azienda Ospedaliera Di Padova

Padua, Italy

Location

Fondazione Irccs Policlinico San Matteo

Pavia, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Rome, Italy

Location

European Hospital

Rome, Italy

Location

Azienda Sanitaria Universitaria Integrata Di Udine (Asuiud)

Udine, 33100, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

Location

Cardialysis Core Laboratory For Imaging

Rotterdam, Netherlands

Location

Thoraxcenter, Universtity of Rotterdam

Rotterdam, Netherlands

Location

Related Publications (6)

• 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.

  PMID: 24157291 BACKGROUND

• 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.

  PMID: 25173339 BACKGROUND

• 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.

  PMID: 18765186 BACKGROUND

• 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.

  PMID: 23765788 BACKGROUND

• 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.

  PMID: 19286089 BACKGROUND

• 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.

  PMID: 26684009 DERIVED

Study Officials

• Flavio L Ribichini, MD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• Michele Pighi, MD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: March 3, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2020
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

IT (8); NL (2)