Registry for the DynamX Coronary Bioadaptor System

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

This study is testing how safe and effective the DynamX stent is for people with coronary artery disease who are getting treatment to open blocked arteries.

Quick facts

• Study type: Observational
• Enrollment: 5000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Elixir Medical Corporation (industry)
• Locations: 17 sites (Pölten and 16 other locations)
• Trial ID: NCT06074549 on ClinicalTrials.gov

What this trial studies

This registry aims to gather data on the safety and performance of the DynamX Novolimus Eluting Coronary Bioadaptor System in patients suffering from coronary artery disease. It will focus on real-world outcomes in patients undergoing percutaneous coronary intervention (PCI) with stent implantation. The study will collect information on the effectiveness of the device in treating ischemic heart disease caused by new lesions in native coronary arteries.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who require PCI with stent implantation and can provide informed consent.

Not a fit: Patients with target lesions in the left main artery or those with prior bypass grafts may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the safety and effectiveness of a new treatment option for patients with coronary artery disease.

How similar studies have performed: Other studies involving similar bioadaptor systems have shown promising results, indicating potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Pölten and 16 other locations

• University Hospital St. Pölten — Pölten, Austria (RECRUITING)
• Curaçao Medical Center — Willemstad, Curacao (RECRUITING)
• Heartology Cardiovascular Hospital — Jakarta, Indonesia (RECRUITING)
• Jakarta Heart Center — Jakarta, Indonesia (RECRUITING)
• Medistra Hospital — Jakarta, Indonesia (RECRUITING)
• Siloam Hospitals — Jakarta, Indonesia (RECRUITING)
• Centro Cardiologico Monzino — Milan, Italy (RECRUITING)
• Azienda Ospedaliera Universitaria "Federico II" — Naples, Italy (RECRUITING)
• Policlinico Tor Vergata — Rome, Italy (RECRUITING)
• Jordon Hospital — Amman, Jordan (RECRUITING)
• The Specialty Hospital — Amman, Jordan (RECRUITING)
• King Fahad Armed Forces Hospital — Jeddah, Saudi Arabia (RECRUITING)
• Istanbul Medipol Mega University Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
• Memorial Bahçelievler Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
• Al Qassimi Hospital — Sharjah city, United Arab Emirates (RECRUITING)
• Tam Duc Heart Hospital — Ho Chi Minh City, Vietnam (RECRUITING)
• Kiến Giang General Hospital — Kiến Giang, Vietnam (RECRUITING)

Study contacts

• Study coordinator: Lisa Tanner

Conditions: Coronary Artery Disease