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DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System | Clinical Trials | Clareo Health

RECRUITING

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

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

NCT06074549•Elixir Medical Corporation

View on ClinicalTrials.gov

Summary

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

Detailed Description

This registry will obtain additional safety, effectiveness, and performance data on the DynamX 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (17)

University Hospital St. Pölten

Pölten, Austria

Curaçao Medical Center

Willemstad, Curacao

Heartology Cardiovascular Hospital

Jakarta, Indonesia

Jakarta Heart Center

Jakarta, Indonesia

Medistra Hospital

Jakarta, Indonesia

Siloam Hospitals

Jakarta, Indonesia

Centro Cardiologico Monzino

Milan, Italy

Azienda Ospedaliera Universitaria "Federico II"

Naples, Italy

Policlinico Tor Vergata

Rome, Italy

Jordon Hospital

Amman, Jordan

Key Dates

Start Date

March 10, 2024

Primary Completion Date

December 1, 2028

Completion Date

December 1, 2028

Last Updated

August 28, 2025

Enrollment

5,000

ESTIMATED participants

Conditions

Coronary Artery Disease

Interventions

DynamX Novolimus-eluting Coronary Bioadaptor System

DEVICE

Contacts

Lisa Tanner

CONTACT

+1 408 636 2000 ltanner@ElixirMedical.com

Elizabeth Lau, PhD

CONTACT

elau@ElixirMedical.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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