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DynamX Bioadaptor Hong Kong Registry

Sponsor
Elixir Medical Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04483791
Collaborator
(none)
50
Enrollment
4
Locations
1
Arm
26
Anticipated Duration (Months)
12.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, non-randomized, multicenter registry

Condition or Disease Intervention/Treatment Phase
  • Combination Product: DynamX Novolimus Eluting Coronary Bioadaptor System
 Phase 4

Detailed Description

Enrollment of up to 50 subjects with up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and<=34 mm in length receiving the DynamX Novolimus Eluting Coronary Bioadaptor System (CSS), with primary, interim clinical follow-up via telephone at 1 month. Follow-up will continue at 6, and 12 months. to capture cardiovascular related hospitalizations related to the study devic

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, non-randomized, multicenter registryProspective, non-randomized, multicenter registry
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Non-Randomized, Clinical Registry of the Dynamx Novolimus Eluting Coronary Bioadaptor System in the Treatment of Patients With De Novo Native Coronary Artery Lesions
Actual Study Start Date :
Sep 30, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: DynamX Novolimus Eluting Coronary Bioadaptor System

DynamX use in de novo coronary artery lesions

Combination Product: DynamX Novolimus Eluting Coronary Bioadaptor System
up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and<=34 mm in length receiving the DynamX Novolimus Eluting Coronary Bioadaptor System
Other Names:
  • Novolimus
  • Bioadaptor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Acute Device Success [procedure]

      Percentage of patients with an attainment of a final result of < 30% residual stenosis using the DynamX bioadaptor with standard pre-dilatation and post-dilatation (if applicable) catheters

    2. Device Oriented Clinical Endpoint [6 months]

      the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization

    Secondary Outcome Measures

    1. Device Oriented Clinical Endpoint [1 month]

      the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization

    2. Device Oriented Clinical Endpoint [12 months]

      the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization

    3. death [1 month]

      cardiac and non-cardiac

    4. death [6 months]

      cardiac and non-cardiac

    5. death [12 months]

      cardiac and non-cardiac

    6. myocardial infarction [1 month]

      target vessel and non-target vessel

    7. myocardial infarction [6 months]

      target vessel and non-target vessel

    8. myocardial infarction [12 months]

      target vessel and non-target vessel

    9. target lesion revascularization [1 month]

      clinically-indicated

    10. target lesion revascularization [6 month]

      clinically-indicated

    11. target lesion revascularization [12 month]

      clinically-indicated

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subject age ≥ 18 and ≤ 80 years

    2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment

    3. Indication for a percutaneous intervention with stent implantation in native epicardial arteries including patients with stable coronary artery disease and acute coronary syndromes (non-ST-elevated myocardial infarction)

    4. Vessel diameter (2.25-3.5 mm) and lesions length ≤ 34 mm suitable for implantation using a single stent per lesion

    5. All lesions requiring PCI should be amendable for implantation with the study stent

    6. Successful pre-dilatation of the first lesion defined as no waist in the inflated pre-dilatation balloon using two orthogonal views using a pre- dilatation balloon diameter size ranging from the reference vessel diameter to 0.25 mm smaller than the reference vessel diameter, and a residual diameter stenosis prior to study device implantation by visual estimate being < 35%

    Exclusion Criteria:

    1. Target lesion / vessel specific

    2. Lesions in the left main

    3. Venous or arterial bypass grafts

    4. In-stent restenosis

    5. Chronic total occlusion

    6. Ostial lesions (< 3 mm from the ostium of the RCA, LAD or Cx)

    7. Stent implanted < 10 mm from the target lesion in the previous 30 days.

    8. Lesion requiring rotablation or atherectomy because of, but not limited to severe calcification

    9. Bifurcation lesions requiring a planned 2 or more stent technique

    10. Patient specific:

    11. STEMI

    12. Acute myocardial infarction with Killip Class III and IV

    13. Known LVEF < 30%

    14. Life expectancy < 1 year

    15. Patients on renal dialysis or known GFR < 30 ml/min

    16. Planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months

    17. Known intolerance to components of the investigational product or medication required (e.g. intolerance to concomitant anticoagulation or antiplatelet therapy)

    18. Subject is receiving or will require chronic anticoagulation therapy (e.g. coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or low molecular weight heparin)

    19. Subject is currently participating in another clinical trial with an investigational drug or device that has not yet completed its primary endpoint

    20. Known pregnancy or breastfeeding

    21. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kwong Wah Hospital Hong Kong Kowloon China
    2 Queen Elizabeth Hospital Hong Kong Kowloon China
    3 Queen Mary Hospital Hong Kong Pok Fu Lam China
    4 Chinese University of Hong Kong / Prince of Wales Hospital Hong Kong Sha Tin China

    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:
    NCT04483791
    Other Study ID Numbers:
    • ELX-CL-2001
    First Posted:
    Jul 23, 2020
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Elixir Medical Corporation
    drug eluting stent
    percutaneous coronary intervention
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Jan 6, 2022