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Cardiac Allograft VasculopathyPhase 4CARTNCT02377648

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

A Phase 4 study testing Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB) in people with Cardiac Allograft Vasculopathy, run by Universita di Verona at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 … Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Allograft Vasculopathy
What is being tested?
Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
10 sitesin 2 countries
Study dates
Jan 2015to Dec 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Italy8 sites

  • Azienda Ospedaliera Brotzu

    Cagliari

  • Azienda Ospedaliera Specialistica Dei Colli

    Naples

  • Azienda Ospedaliera Di Padova

    Padua

  • Fondazione Irccs Policlinico San Matteo

    Pavia

  • Azienda Ospedaliera San Camillo Forlanini

    Rome

  • European Hospital

    Rome

  • Azienda Sanitaria Universitaria Integrata Di Udine (Asuiud)

    Udine, 33100

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126

Other trials in Italy

Netherlands2 sites

  • Cardialysis Core Laboratory For Imaging

    Rotterdam

  • Thoraxcenter, Universtity of Rotterdam

    Rotterdam

Other trials in Netherlands

About this study

Official title: Everolimus-eluting Bioresorbable Vascular Scaffold System in the Treatment of Cardiac Allograft Vasculopathy in Heart Transplant Recipients: A Prospective Multicenter Pilot Study

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:

Read more
  • 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

Being tested
Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB)
Keywords
Cardiac Allograft Vasculopathy, Heart Transplant, Bioresorbable Vascular Scaffold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02377648
Study groupRoleWhat they receive
ABSORB Bioresorbable Vascular ScaffoldExperimentalEverolimus-Eluting Bioresorbable Vascular Scaffold implantation
Receives: Device: Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: One Year

Secondary outcomes (63)

  1. Device success (lesion based analysis)

    Measured: Basal procedure

  2. Procedural success (subject based analysis)

    Measured: Basal procedure

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

    Measured: 30 days, 180 days, 2 years and 3 years

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

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

  5. Target lesion revascularization (TLR)

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

  6. Target vessel revascularization (TVR)

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

  7. Non-target vessel revascularization (NTVR)

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

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

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

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

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

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

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

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

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

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

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

  13. Scaffold thrombosis

    Timing (Acute)

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

  14. Scaffold thrombosis

    Timing (Subacute)

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

  15. Scaffold thrombosis

    Timing (Late)

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

  16. Scaffold thrombosis

    Timing (Very late)

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

  17. Scaffold thrombosis

    Evidence (Definite)

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

  18. Scaffold thrombosis

    Evidence (Probable)

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

  19. Scaffold thrombosis

    Evidence (Possible)

    Measured: 30 days, 180 days, 1 year, 2 years and 3 years

  20. Angiographic Endpoints

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

    Measured: Basal procedure, 1 year and 3 years

  21. Angiographic Endpoints

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

    Measured: Basal procedure, 1 year and 3 years

  22. Angiographic Endpoints

    In-scaffold Diameter Stenosis (DS) (%)

    Measured: Basal procedure, 1 year and 3 years

  23. Angiographic Endpoints

    In-scaffold late loss (mm)

    Measured: Basal procedure, 1 year and 3 years

  24. Angiographic Endpoints

    Proximal late loss (mm)

    Measured: Basal procedure, 1 year and 3 years

  25. Angiographic Endpoints

    Distal late loss (mm)

    Measured: Basal procedure, 1 year and 3 years

  26. Angiographic Endpoints

    In-scaffold absolute minimal luminal area (mm2)

    Measured: Basal procedure, 1 year and 3 years

  27. Angiographic Endpoints

    In-scaffold minimal luminal cross sectional area (mm2)

    Measured: Basal procedure, 1 year and 3 years

  28. Angiographic Endpoints

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

    Measured: Basal procedure, 1 year and 3 years

  29. Angiographic Endpoints

    In-segment binary restenosis

    Measured: Basal procedure, 1 year and 3 years

  30. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Vessel (EEM) area (mm2)

    Measured: Basal procedure and 3 years

  31. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Vessel volume (mm3)

    Measured: Basal procedure and 3 years

  32. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Average lumen area (mm2)

    Measured: Basal procedure and 3 years

  33. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Lumen volume (mm3)

    Measured: Basal procedure and 3 years

  34. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Plaque area (mm2)

    Measured: Basal procedure and 3 years

  35. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Plaque volume (mm3)

    Measured: Basal procedure and 3 years

  36. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Minimal lumen area (mm2)

    Measured: Basal procedure and 3 years

  37. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Lumen area stenosis (%)

    Measured: Basal procedure and 3 years

  38. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Vessel volume index (mm3/mm)

    Measured: Basal procedure and 3 years

  39. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Lumen volume index (mm3/mm)

    Measured: Basal procedure and 3 years

  40. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Plaque volume index (mm3/mm)

    Measured: Basal procedure and 3 years

  41. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Plaque burden, %

    Measured: Basal procedure and 3 years

  42. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Projected MLD (mm)

    Measured: Basal procedure and 3 years

  43. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Dense calcium volume, area, percentage

    Measured: Basal procedure and 3 years

  44. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Necrotic core volume, area, percentage

    Measured: Basal procedure and 3 years

  45. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Fibrofatty volume, area, percentage

    Measured: Basal procedure and 3 years

  46. Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints

    Fibrous volume, area, percentage

    Measured: Basal procedure and 3 years

  47. Optical Coherence Tomography Endpoints

    Maximal intimal thickness (MIT) (mm)

    Measured: Basal procedure and 3 years

  48. Optical Coherence Tomography Endpoints

    Media thickness at MIT (mm)

    Measured: Basal procedure and 3 years

  49. Optical Coherence Tomography Endpoints

    Mean lumen area (mm2)

    Measured: Basal procedure and 3 years

  50. Optical Coherence Tomography Endpoints

    Intimal area (mm2)

    Measured: Basal procedure and 3 years

  51. Optical Coherence Tomography Endpoints

    Maximal, minimal and mean lumen diameter (mm)

    Measured: Basal procedure and 3 years

  52. Optical Coherence Tomography Endpoints

    Discernible struts

    Measured: Basal procedure and 3 years

  53. Optical Coherence Tomography Endpoints

    Atherosclerosis assessment (Eccentric plaque)

    Measured: Basal procedure and 3 years

  54. Optical Coherence Tomography Endpoints

    Atherosclerosis assessment (Calcification)

    Measured: Basal procedure and 3 years

  55. Optical Coherence Tomography Endpoints

    Atherosclerosis assessment (Lipid)

    Measured: Basal procedure and 3 years

  56. Optical Coherence Tomography Endpoints

    Vulnerable plaque assessment (thin-cap fibroatheroma)

    Measured: Basal procedure and 3 years

  57. Optical Coherence Tomography Endpoints

    Vulnerable plaque assessment (macrophages)

    Measured: Basal procedure and 3 years

  58. Optical Coherence Tomography Endpoints

    Vulnerable plaque assessment (microchannels)

    Measured: Basal procedure and 3 years

  59. Optical Coherence Tomography Endpoints

    Vulnerable plaque assessment (calcific nod)

    Measured: Basal procedure and 3 years

  60. Optical Coherence Tomography Endpoints

    Lesions assessment (Intimal laceration)

    Measured: Basal procedure and 3 years

  61. Optical Coherence Tomography Endpoints

    Lesions assessment (plaque rupture)

    Measured: Basal procedure and 3 years

  62. Optical Coherence Tomography Endpoints

    Lesions assessment (intraluminal thrombus)

    Measured: Basal procedure and 3 years

  63. Optical Coherence Tomography Endpoints

    Lesions assessment (layered complex plaque)

    Measured: Basal procedure and 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionSep 2017
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02377648
Sponsor's protocol ID
CART
Acronym
CART
Status last verified
Sep 2021
First submitted
16 Feb 2015
Last updated
30 Sep 2021
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB) in people with Cardiac Allograft Vasculopathy, run by Universita di Verona at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02377648, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.

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