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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377648
Recruitment Status : Active, not recruiting
First Posted : March 3, 2015
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Flavio Ribichini, Universita di Verona

Tracking Information
First Submitted Date  ICMJE February 16, 2015
First Posted Date  ICMJE March 3, 2015
Last Update Posted Date May 1, 2018
Actual Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02377648 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • 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 [ Time Frame: 30 days, 180 days, 1 year, 2 years and 3 years ]
    Timing (Acute)
  • Scaffold thrombosis [ Time Frame: 30 days, 180 days, 1 year, 2 years and 3 years ]
    Timing (Subacute)
  • Scaffold thrombosis [ Time Frame: 30 days, 180 days, 1 year, 2 years and 3 years ]
    Timing (Late)
  • Scaffold thrombosis [ Time Frame: 30 days, 180 days, 1 year, 2 years and 3 years ]
    Timing (Very late)
  • Scaffold thrombosis [ Time Frame: 30 days, 180 days, 1 year, 2 years and 3 years ]
    Evidence (Definite)
  • Scaffold thrombosis [ Time Frame: 30 days, 180 days, 1 year, 2 years and 3 years ]
    Evidence (Probable)
  • Scaffold thrombosis [ Time Frame: 30 days, 180 days, 1 year, 2 years and 3 years ]
    Evidence (Possible)
  • Angiographic Endpoints [ Time Frame: Basal procedure, 1 year and 3 years ]
    In-scaffold Reference Vessel Diameter (RVD) (mm)
  • Angiographic Endpoints [ Time Frame: Basal procedure, 1 year and 3 years ]
    In-scaffold Minimal Lumen Diameter (MLD) (mm)
  • Angiographic Endpoints [ Time Frame: Basal procedure, 1 year and 3 years ]
    In-scaffold Diameter Stenosis (DS) (%)
  • Angiographic Endpoints [ Time Frame: Basal procedure, 1 year and 3 years ]
    In-scaffold late loss (mm)
  • Angiographic Endpoints [ Time Frame: Basal procedure, 1 year and 3 years ]
    Proximal late loss (mm)
  • Angiographic Endpoints [ Time Frame: Basal procedure, 1 year and 3 years ]
    Distal late loss (mm)
  • Angiographic Endpoints [ Time Frame: Basal procedure, 1 year and 3 years ]
    In-scaffold absolute minimal luminal area (mm2)
  • Angiographic Endpoints [ Time Frame: Basal procedure, 1 year and 3 years ]
    In-scaffold minimal luminal cross sectional area (mm2)
  • Angiographic Endpoints [ Time Frame: Basal procedure, 1 year and 3 years ]
    In-segment late loss (mm) In-stent binary restenosis (%)
  • Angiographic Endpoints [ Time Frame: Basal procedure, 1 year and 3 years ]
    In-segment binary restenosis
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Vessel (EEM) area (mm2)
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Vessel volume (mm3)
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Average lumen area (mm2)
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Lumen volume (mm3)
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Plaque area (mm2)
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Plaque volume (mm3)
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Minimal lumen area (mm2)
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Lumen area stenosis (%)
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Vessel volume index (mm3/mm)
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Lumen volume index (mm3/mm)
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Plaque volume index (mm3/mm)
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Plaque burden, %
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Projected MLD (mm)
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Dense calcium volume, area, percentage
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Necrotic core volume, area, percentage
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Fibrofatty volume, area, percentage
  • Intravascular Ultrasound/Intravascular Ultrasound-Virtual Histology Endpoints [ Time Frame: Basal procedure and 3 years ]
    Fibrous volume, area, percentage
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Maximal intimal thickness (MIT) (mm)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Media thickness at MIT (mm)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Mean lumen area (mm2)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Intimal area (mm2)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Maximal, minimal and mean lumen diameter (mm)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Discernible struts
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Atherosclerosis assessment (Eccentric plaque)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Atherosclerosis assessment (Calcification)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Atherosclerosis assessment (Lipid)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Vulnerable plaque assessment (thin-cap fibroatheroma)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Vulnerable plaque assessment (macrophages)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Vulnerable plaque assessment (microchannels)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Vulnerable plaque assessment (calcific nod)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Lesions assessment (Intimal laceration)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Lesions assessment (plaque rupture)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Lesions assessment (intraluminal thrombus)
  • Optical Coherence Tomography Endpoints [ Time Frame: Basal procedure and 3 years ]
    Lesions assessment (layered complex plaque)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Everolimus - Eluting Bioresorbable Vascular Scaffold for Cardiac Allograft Vasculopathy
Official Title  ICMJE Everolimus-eluting Bioresorbable Vascular Scaffold System in the Treatment of Cardiac Allograft Vasculopathy in Heart Transplant Recipients: A Prospective Multicenter Pilot Study
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Allograft Vasculopathy
Intervention  ICMJE Device: 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.
Study Arms  ICMJE Experimental: ABSORB Bioresorbable Vascular Scaffold
Everolimus-Eluting Bioresorbable Vascular Scaffold implantation
Intervention: Device: Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 17, 2017)
34
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2015)
30
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02377648
Other Study ID Numbers  ICMJE CART
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Flavio Ribichini, Universita di Verona
Study Sponsor  ICMJE Universita di Verona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Flavio L Ribichini, MD Universita di Verona
PRS Account Universita di Verona
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP