Clinical trial NCT06074549: DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Novolimus Eluting Coronary Bioadaptor System
Official title: DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Novolimus Eluting Coronary Bioadaptor System (Bio-RESTORE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: Elixir Medical Corporation
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing Percutaneous Coronary Intervention (PCI) who receive at least one DynamX Bioadaptor implant in a commercial setting in accordance with the product's Instructions for Use (IFU).

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Device Oriented Clinical Endpoint
timeFrame: 12 Months
Secondary outcomes:
measure: Clinical Device Success
timeFrame: In-Hospital, assessed up to 7 days after procedure
measure: Clinical Procedural Success
timeFrame: In-Hospital, assessed up to 7 days after procedure
measure: Device Oriented Clinical Endpoint
timeFrame: 30 days
measure: Patient Oriented Clinical Endpoint
timeFrame: 30 days and 12 months
measure: Rate of target vessel failure (TVF)
timeFrame: 30 days and 12 months
measure: Rate of all revascularization
timeFrame: 30 days and 12 months
measure: Rate of all MI
timeFrame: 30 days and 12 months
measure: Rate of all-cause death
timeFrame: 30 days and 12 months
measure: Composite of cardiovascular death, any myocardial infarction, and any revascularization
timeFrame: 30 days and 12 months
measure: Rate of stroke
timeFrame: 30 days and 12 months
measure: Rate of probable or definite stent thrombosis
timeFrame: 30 days and 12 months
measure: Duration of DAPT
timeFrame: 30 days and 12 months
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Fahad Armed Forces Hospital
Study officials:
References: