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CompletedNCT02377648CARTUpdated Sep 30, 2021

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

A Phase 4 interventional study of Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB) in Cardiac Allograft Vasculopathy, sponsored by Universita di Verona. Completed at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-30.

Sponsored by Universita di Verona · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Cardiac Allograft Vasculopathy

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Keywords

  • Cardiac Allograft Vasculopathy
  • Heart Transplant
  • Bioresorbable Vascular Scaffold
03

In context

Vascular Diseases

1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.

This study's enrollment of 34 is below the median of 78 across 639 interventional studies indexed under Vascular Diseases.

Browse Vascular Diseases studies →

Lead sponsor

Universita di Verona is the lead sponsor of 122 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    ABSORB Bioresorbable Vascular Scaffold

    Everolimus-Eluting Bioresorbable Vascular Scaffold implantation

    Device: Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB)

Interventions

  • DeviceEverolimus-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.

06

What researchers measure

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.

    Time frame: One Year

Secondary outcomes

  1. Device success (lesion based analysis)

    Time frame: Basal procedure

  2. Procedural success (subject based analysis)

    Time frame: Basal procedure

  3. Death (cardiac, vascular, non-cardiovascular)

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

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

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

  5. Target lesion revascularization (TLR)

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

  6. Target vessel revascularization (TVR)

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

  7. Non-target vessel revascularization (NTVR)

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

  8. Composite (Death/All MI/ Graft failure)

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

  9. Composite (Cardiac death/TV-MI/TLR )

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

  10. Composite (Cardiac death/all MI/TLR )

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

  11. Composite (Cardiac death/all MI/TVR)

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

  12. Composite (Death/All MI/all revascularization)

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

  13. Scaffold thrombosis

    Timing (Acute)

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

  14. Scaffold thrombosis

    Timing (Subacute)

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

  15. Scaffold thrombosis

    Timing (Late)

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

  16. Scaffold thrombosis

    Timing (Very late)

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

  17. Scaffold thrombosis

    Evidence (Definite)

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

  18. Scaffold thrombosis

    Evidence (Probable)

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

  19. Scaffold thrombosis

    Evidence (Possible)

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

  20. Angiographic Endpoints

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

    Time frame: Basal procedure, 1 year and 3 years

  21. Angiographic Endpoints

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

    Time frame: Basal procedure, 1 year and 3 years

  22. Angiographic Endpoints

    In-scaffold Diameter Stenosis (DS) (%)

    Time frame: Basal procedure, 1 year and 3 years

  23. Angiographic Endpoints

    In-scaffold late loss (mm)

    Time frame: Basal procedure, 1 year and 3 years

  24. Angiographic Endpoints

    Proximal late loss (mm)

    Time frame: Basal procedure, 1 year and 3 years

  25. Angiographic Endpoints

    Distal late loss (mm)

    Time frame: Basal procedure, 1 year and 3 years

  26. Angiographic Endpoints

    In-scaffold absolute minimal luminal area (mm2)

    Time frame: Basal procedure, 1 year and 3 years

  27. Angiographic Endpoints

    In-scaffold minimal luminal cross sectional area (mm2)

    Time frame: Basal procedure, 1 year and 3 years

  28. Angiographic Endpoints

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

    Time frame: Basal procedure, 1 year and 3 years

  29. Angiographic Endpoints

    In-segment binary restenosis

    Time frame: Basal procedure, 1 year and 3 years

  30. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Vessel (EEM) area (mm2)

    Time frame: Basal procedure and 3 years

  31. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Vessel volume (mm3)

    Time frame: Basal procedure and 3 years

  32. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Average lumen area (mm2)

    Time frame: Basal procedure and 3 years

  33. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Lumen volume (mm3)

    Time frame: Basal procedure and 3 years

  34. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Plaque area (mm2)

    Time frame: Basal procedure and 3 years

  35. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Plaque volume (mm3)

    Time frame: Basal procedure and 3 years

  36. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Minimal lumen area (mm2)

    Time frame: Basal procedure and 3 years

  37. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Lumen area stenosis (%)

    Time frame: Basal procedure and 3 years

  38. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Vessel volume index (mm3/mm)

    Time frame: Basal procedure and 3 years

  39. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Lumen volume index (mm3/mm)

    Time frame: Basal procedure and 3 years

  40. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Plaque volume index (mm3/mm)

    Time frame: Basal procedure and 3 years

  41. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Plaque burden, %

    Time frame: Basal procedure and 3 years

  42. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Projected MLD (mm)

    Time frame: Basal procedure and 3 years

  43. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Dense calcium volume, area, percentage

    Time frame: Basal procedure and 3 years

  44. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Necrotic core volume, area, percentage

    Time frame: Basal procedure and 3 years

  45. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Fibrofatty volume, area, percentage

    Time frame: Basal procedure and 3 years

  46. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Fibrous volume, area, percentage

    Time frame: Basal procedure and 3 years

  47. Optical Coherence Tomography Endpoints

    Maximal intimal thickness (MIT) (mm)

    Time frame: Basal procedure and 3 years

  48. Optical Coherence Tomography Endpoints

    Media thickness at MIT (mm)

    Time frame: Basal procedure and 3 years

  49. Optical Coherence Tomography Endpoints

    Mean lumen area (mm2)

    Time frame: Basal procedure and 3 years

  50. Optical Coherence Tomography Endpoints

    Intimal area (mm2)

    Time frame: Basal procedure and 3 years

  51. Optical Coherence Tomography Endpoints

    Maximal, minimal and mean lumen diameter (mm)

    Time frame: Basal procedure and 3 years

  52. Optical Coherence Tomography Endpoints

    Discernible struts

    Time frame: Basal procedure and 3 years

  53. Optical Coherence Tomography Endpoints

    Atherosclerosis assessment (Eccentric plaque)

    Time frame: Basal procedure and 3 years

  54. Optical Coherence Tomography Endpoints

    Atherosclerosis assessment (Calcification)

    Time frame: Basal procedure and 3 years

  55. Optical Coherence Tomography Endpoints

    Atherosclerosis assessment (Lipid)

    Time frame: Basal procedure and 3 years

  56. Optical Coherence Tomography Endpoints

    Vulnerable plaque assessment (thin-cap fibroatheroma)

    Time frame: Basal procedure and 3 years

  57. Optical Coherence Tomography Endpoints

    Vulnerable plaque assessment (macrophages)

    Time frame: Basal procedure and 3 years

  58. Optical Coherence Tomography Endpoints

    Vulnerable plaque assessment (microchannels)

    Time frame: Basal procedure and 3 years

  59. Optical Coherence Tomography Endpoints

    Vulnerable plaque assessment (calcific nod)

    Time frame: Basal procedure and 3 years

  60. Optical Coherence Tomography Endpoints

    Lesions assessment (Intimal laceration)

    Time frame: Basal procedure and 3 years

  61. Optical Coherence Tomography Endpoints

    Lesions assessment (plaque rupture)

    Time frame: Basal procedure and 3 years

  62. Optical Coherence Tomography Endpoints

    Lesions assessment (intraluminal thrombus)

    Time frame: Basal procedure and 3 years

  63. Optical Coherence Tomography Endpoints

    Lesions assessment (layered complex plaque)

    Time frame: Basal procedure and 3 years

07

Study locations

10 sites
  • 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, 33100, Italy
  • Azienda Ospedaliera Universitaria Integrata Verona
    Verona, 37126, Italy
  • Cardialysis Core Laboratory For Imaging
    Rotterdam, Netherlands
  • Thoraxcenter, Universtity of Rotterdam
    Rotterdam, Netherlands
08

References and documents

Publications

  • 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. PubMed 24157291 ↗
  • 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. PubMed 25173339 ↗
  • 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. PubMed 18765186 ↗
  • 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. PubMed 23765788 ↗
  • 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. PubMed 19286089 ↗
  • 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. PubMed 26684009 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02377648
Lead sponsor
Universita di Verona
Responsible party
Flavio Ribichini (Medical Doctor, Universita di Verona) — Principal investigator
First posted
Mar 3, 2015
Start date
Jan 2015
Primary completion
Sep 2017
Completion
Dec 2020
Last update
Sep 30, 2021

Study contacts

Flavio L Ribichini, MD
principal investigator · Universita di Verona
Michele Pighi, MD
principal investigator · Universita di Verona

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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