Ireland
--:--IST
Latest
Recruiting Observational

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

NCT06074549 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-03-10
Last updated
2025-08-28

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

DynamX Novolimus-eluting Coronary Bioadaptor System

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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

Trial sites (17)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06074549 on ClinicalTrials.gov ↗ ← All trials in Italy