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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

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).

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Myocardial Revascularization Tomography, Optical Coherence Device: Fantom Encore Bioresorbable scaffold implantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: Safety and Efficacy of the FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo Coronary Artery Disease: the ENCORE-I Study
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 31, 2025

Arm Intervention/treatment
Single arm
Fantom Encore Bioresorbable scaffold implantation
Device: Fantom Encore Bioresorbable scaffold implantation
Fantom Encore Bioresorbable scaffold implantation




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Subcomponents of DOCE [ Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months ]
    Subcomponents of the Device-Oriented Composite Endpoints

  2. Target vessel revascularization (TVR) [ Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months ]
    Target vessel revascularization

  3. Definite or probable stent thrombosis (ST) [ Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months ]
    Stent thrombosis


Other Outcome Measures:
  1. Angiographic outcomes at baseline [ Time Frame: 0 days ]
    Acute gain

  2. Angiographic outcomes at baseline [ Time Frame: 0 days ]
    acute recoil

  3. 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)

  4. Angiographic outcomes at follow-up [ Time Frame: 13 months ]
    In-device and in-segment late lumen loss (LLL)

  5. Angiographic outcomes at follow-up [ Time Frame: 13 months ]
    In-device and in-segment binary restenosis rate

  6. Device performance [ Time Frame: 0 days ]
    Device success

  7. Device performance [ Time Frame: 0 days ]
    Procedural success

  8. Optical coherence tomography outcomes at baseline [ Time Frame: 0 days ]
    Incomplete strut apposition (ISA)

  9. Optical coherence tomography outcomes at baseline [ Time Frame: 0 days ]
    Scaffold expansion

  10. Optical coherence tomography outcomes at baseline [ Time Frame: 0 days ]
    Scaffold eccentricity

  11. Optical coherence tomography outcomes at baseline [ Time Frame: 0 days ]
    Scaffold symmetry index

  12. Optical coherence tomography outcomes at baseline [ Time Frame: 0 days ]
    Edge dissection

  13. Optical coherence tomography outcomes at baseline [ Time Frame: 0 days ]
    In-device and in-segment endothelial shear stress

  14. Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Neointima thickness

  15. Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Percentage of patent struts

  16. Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Percentage of uncovered struts

  17. Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Persistent ISA

  18. Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Acquired ISA

  19. Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Scaffold eccentricity index

  20. Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    Scaffold symmetry index

  21. Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    In-device and in-segment late lumen area loss

  22. Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    In-device and in-segment binary restenosis rate.

  23. Optical coherence tomography outcomes at follow-up [ Time Frame: 13 months ]
    In-device and in-segment endothelial shear stress



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04591938


Contacts
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Contact: Joost Daemen, MD, PhD +31 10 703 5260 j.daemen@erasmusmc.nl

Locations
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Belgium
Ziekenhuis Oost-Limburg Not yet recruiting
Genk, Belgium
Contact: Jo Dens, Prof. Dr.         
Universitair Ziekenhuis Leuven Not yet recruiting
Leuven, Belgium
Contact: Tom Adriaenssens, Prof. Dr.         
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Joost Daemen, MD;PhD    Tel: +31 10 703 5260    j.daemen@erasmusmc.nl   
Contact: Maria Natalia Tovar Forero, MD    Tel: +31 10 703 8896    m.tovarforero@erasmusmc.nl   
Sponsors and Collaborators
Joost Daemen
Horizon 2020 - European Commission
REVA Medical, Inc.
Investigators
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Principal Investigator: Joost Daemen, MD, PhD Erasmus Medical Center
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Responsible Party: Joost Daemen, Interventional Cardiologist, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04591938    
Other Study ID Numbers: ENCORE-I
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joost Daemen, Erasmus Medical Center:
Bioresorbable scaffold
Percutaneous Coronary Intervention
OCT