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Bio-RESTORE: DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Novolimus Eluting Coronary Bioadaptor System

Sponsor
Elixir Medical Corporation (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06074549
Collaborator
(none)
5,000
Enrollment
37
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this registry is to confirm the safety, and performance of the DynamX Novolimus Eluting Coronary Bioadaptor System in patients with coronary artery disease.

Condition or Disease Intervention/Treatment Phase
  • Device: DynamX Novolimus-eluting Coronary Bioadaptor System

Detailed Description

This registry will obtain additional safety, effectiveness, and performance data on the DynamX Novolimus-Eluting Coronary Bioadaptor System in the treatment of patients with ischemic heart disease due to de novo native coronary artery lesions in a real-world patient population.

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Novolimus Eluting Coronary Bioadaptor System (Bio-RESTORE)
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Open Label

DynamX Novolimus-eluting Coronary Bioadaptor System

Device: DynamX Novolimus-eluting Coronary Bioadaptor System
All patients will receive at least one DynamX Bioadaptor implant in a commercial setting in accordance with the product's Instructions for Use
Other Names:
  • DynamX Bioadaptor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Device Oriented Clinical Endpoint [12 Months]

      Composite of Target Lesion Failure (TLF): cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR), per ARC-2

    Secondary Outcome Measures

    1. Clinical Device Success [In-Hospital, assessed up to 7 days after procedure]

      Achievement of a final residual stenosis <30% by QCA or visual estimation, using the study device and without a device deficiency

    2. Clinical Procedural Success [In-Hospital, assessed up to 7 days after procedure]

      Achievement of a final residual stenosis <30% by QCA or visual estimation, using the study device, with or without any adjunctive devices, and without TLF

    3. Device Oriented Clinical Endpoint [30 days]

      Composite of TLF: cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR), per ARC-2

    4. Patient Oriented Clinical Endpoint [30 days and 12 months]

      Composite of all-cause death, any stroke, any myocardial infarction (MI) (includes non-target vessel territory) and any revascularization.

    5. Rate of target vessel failure (TVF) [30 days and 12 months]

      Composite of cardiovascular death, TV-MI, or target vessel revascularization (TVR).

    6. Rate of all revascularization [30 days and 12 months]

      Target lesion, target vessel, non-target lesion, non-target vessel; clinically driven and non-clinically driven.

    7. Rate of all MI [30 days and 12 months]

      Target and non-target vessel

    8. Rate of all-cause death [30 days and 12 months]

      Cardiovascular, Non-Cardiovascular, Unknown

    9. Composite of cardiovascular death, any myocardial infarction, and any revascularization [30 days and 12 months]

    10. Rate of stroke [30 days and 12 months]

    11. Rate of probable or definite stent thrombosis [30 days and 12 months]

    12. Duration of DAPT [30 days and 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Over 18 years of age

    2. Patient understands the trial requirements and treatment procedures and provides informed consent

    3. Patient indicated for PCI with stent implantation and receive at least one DynamX Bioadaptor implant in accordance with the product's Instructions for Use (IFU).

    Exclusion Criteria:

    1. Target Lesion(s) in the left main artery

    2. Prior venous or arterial bypass grafts

    3. In-stent restenosis

    4. Patient is currently participating in another clinical trial with an investigational device or an investigational drug that has the potential to impact study results (e.g., anti-thrombotic or anti-platelet medications) that has not yet completed its primary endpoint

    5. Patient is, in the opinion of the Investigator, unable to comply with the requirements of the study protocol or is unsuitable for the registry for any reason

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Elixir Medical Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elixir Medical Corporation
    ClinicalTrials.gov Identifier:
    NCT06074549
    Other Study ID Numbers:
    • ELX-CL-2002
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Oct 10, 2023