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

Last updated: April 22, 2024
Sponsor: Elixir Medical Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Vascular Diseases

Atherosclerosis

Treatment

DynamX Novolimus-eluting Coronary Bioadaptor System

Clinical Study ID

NCT06074549
ELX-CL-2002
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Over 18 years of age
  2. Patient understands the trial requirements and treatment procedures and providesinformed consent
  3. Patient indicated for PCI with stent implantation and receive at least one DynamXBioadaptor implant in accordance with the product's Instructions for Use (IFU).

Exclusion

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

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: DynamX Novolimus-eluting Coronary Bioadaptor System
Phase:
Study Start date:
March 10, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • King Fahad Armed Forces Hospital

    Jeddah, 23311
    Saudi Arabia

    Active - Recruiting

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