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

Elixir Medical

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Device: DynamX Novolimus-eluting Coronary Bioadaptor System

Study type

Observational

Funder types

Industry

Identifiers

NCT06074549

ELX-CL-2002

Details and patient eligibility

About

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.

Full 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.

Enrollment

5,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Over 18 years of age
Patient understands the trial requirements and treatment procedures and provides informed consent
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

Target Lesion(s) in the left main artery
Prior venous or arterial bypass grafts
In-stent restenosis
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
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