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FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD: the ENCORE-I Study

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ClinicalTrials.gov Identifier: NCT04591938
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Horizon 2020 - European Commission
REVA Medical, Inc.
Information provided by (Responsible Party):
Joost Daemen, Erasmus Medical Center

Tracking Information
First Submitted Date  ICMJE October 6, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
Device-Oriented Composite Endpoint (DOCE) [ Time Frame: 12 months ]
A composite of cardiac death, target vessel-related non-fatal myocardial infarction (MI) and clinically-driven target lesion revascularization(CD-TLR).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
  • Subcomponents of DOCE [ Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months ]
    Subcomponents of the Device-Oriented Composite Endpoints
  • Target vessel revascularization (TVR) [ Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months ]
    Target vessel revascularization
  • Definite or probable stent thrombosis (ST) [ Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months ]
    Stent thrombosis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 12, 2020)
  • Angiographic outcomes at baseline [ Time Frame: 0 days ]
    Acute gain
  • Angiographic outcomes at baseline [ Time Frame: 0 days ]
    acute recoil
  • Angiographic outcomes at baseline [ Time Frame: 0 days ]
    Incidence of procedural complications (dissection >B, perforation, vessel closure, slow flow or no-reflow, intra-procedure scaffold thrombosis)
  • Angiographic outcomes at follow-up [ Time Frame: 13 months ]
    In-device and in-segment late lumen loss (LLL)
  • Angiographic outcomes at follow-up [ Time Frame: 13 months ]
    In-device and in-segment binary restenosis rate
  • Device performance [ Time Frame: 0 days ]
    Device success
  • Device performance [ Time Frame: 0 days ]
    Procedural success
  • Optical coherence tomography outcomes at baseline [ Time Frame: 0 days ]
    Incomplete strut apposition (ISA)
  • Optical coherence tomography outcomes at baseline [ Time Frame: 0 days ]
    Scaffold expansion
  • Optical coherence tomography outcomes at baseline [ Time Frame: 0 days ]
    Scaffold eccentricity
  • Optical coherence tomography outcomes at baseline [ Time Frame: 0 days ]
    Scaffold symmetry index
  • Optical coherence tomography outcomes at baseline [ Time Frame: 0 days ]
    Edge dissection
  • Optical coherence tomography outcomes at baseline [ Time Frame: 0 days ]
    In-device and in-segment endothelial shear stress
  • Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Neointima thickness
  • Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Percentage of patent struts
  • Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Percentage of uncovered struts
  • Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Persistent ISA
  • Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Acquired ISA
  • Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Scaffold eccentricity index
  • Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Scaffold symmetry index
  • Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    In-device and in-segment late lumen area loss
  • Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    In-device and in-segment binary restenosis rate.
  • Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    In-device and in-segment endothelial shear stress
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD: the ENCORE-I Study
Official Title  ICMJE Safety and Efficacy of the FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo Coronary Artery Disease: the ENCORE-I Study
Brief Summary Prospective, multicentre, non-randomized, investigator-initiated study aiming to assess the safety and efficacy of the Fantom Encore sirolimus-eluting bioresorbable scaffold (BRS).
Detailed Description

Up to 50 consecutive participants with de-novo non-complex obstructive coronary lesions and non-ST elevation acute coronay syndromes or stable angina pectoris will be included in the Netherlands and Belgium.

Device performance and behaviour will be assessed by angiography and optical coherence tomography at the index procedure and at 13 months follow-up.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, multicentre, non-randomized, investigator-initiated study
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Percutaneous Coronary Intervention
  • Myocardial Revascularization
  • Tomography, Optical Coherence
Intervention  ICMJE Device: Fantom Encore Bioresorbable scaffold implantation
Fantom Encore Bioresorbable scaffold implantation
Study Arms  ICMJE Single arm
Fantom Encore Bioresorbable scaffold implantation
Intervention: Device: Fantom Encore Bioresorbable scaffold implantation
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 12, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older
  • Stable angina, unstable angina or documented silent ischemia (invasive or non-invasive test) or non-ST segment elevation acute myocardial infarction.
  • De-novo non-complex coronary obstructive lesions (>50% stenosis as assessed by quantitative coronary analysis (QCA))
  • The patient is willing and able to comply with the specified follow-up evaluations.
  • Reference vessel diameter (RVD) ≥ 2.5 mm and ≤ 4.0 mm by QCA.
  • During pre-dilatation, the pre-dilatation balloon is uniformly expanded to the full intended diameter.
  • Target segment suitable for OCT imaging

Exclusion Criteria:

  • Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow 0 or 1.
  • Target lesion located within 5.0 mm of vessel origin.
  • Lesion type ACC/AHA C.
  • Heavily calcified lesion
  • Severe tortuosity
  • Target lesion is located in or supplied by an arterial or venous bypass graft.
  • Target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
  • Unsuccessful pre-dilatation, defined as a residual diameter stenosis ≥ 30%, assessed by QCA.
  • Planned future revascularization of non-culprit lesions.
  • Presence of another device (stent or scaffold) located within the same segment (5mm from the target lesion borders).
  • Patient is currently participating in another study with an investigational device or an investigational drug and has not completed the entire follow-up period.
  • Impaired renal function (eGFR <30ml/min).
  • Patient has a contraindication for the use of double antiplatelet therapy for at least 12 months.
  • Pregnant or breastfeeding patients.
  • Patient has a known allergy to contrast medium, sirolimus, Tyrosine-derived polycarbonate or other structurally related compounds.
  • Patient is receiving chronic oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (diabetes mellitus is not an exclusion criteria).
  • Patient has a co-morbidity, which reduces life expectancy to ≤ 24 months, or social-economic factors making compliance with the study requirements difficult.
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: Joost Daemen, MD, PhD +31 10 703 5260 j.daemen@erasmusmc.nl
Listed Location Countries  ICMJE Belgium,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04591938
Other Study ID Numbers  ICMJE ENCORE-I
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joost Daemen, Erasmus Medical Center
Study Sponsor  ICMJE Joost Daemen
Collaborators  ICMJE
  • Horizon 2020 - European Commission
  • REVA Medical, Inc.
Investigators  ICMJE
Principal Investigator: Joost Daemen, MD, PhD Erasmus Medical Center
PRS Account Erasmus Medical Center
Verification Date October 2020

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