NCT06074549RecruitingNot Applicable
DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System (Bio-RESTORE)
Elixir Medical Corporation17 sites in 9 countries5,000 target enrollmentStarted: March 10, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Elixir Medical Corporation
- Enrollment
- 5,000
- Locations
- 17
- Primary Endpoint
- Device Oriented Clinical Endpoint
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Device Oriented Clinical Endpoint
Time Frame: 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
Secondary Outcomes
- Rate of all MI(30 days and 12 months)
- Clinical Procedural Success(In-Hospital, assessed up to 7 days after procedure)
- Device Oriented Clinical Endpoint(30 days)
- Rate of target vessel failure (TVF)(30 days and 12 months)
- Rate of all revascularization(30 days and 12 months)
- Rate of all-cause death(30 days and 12 months)
- Clinical Device Success(In-Hospital, assessed up to 7 days after procedure)
- Patient Oriented Clinical Endpoint(30 days and 12 months)
- Composite of cardiovascular death, any myocardial infarction, and any revascularization(30 days and 12 months)
- Rate of stroke(30 days and 12 months)
- Rate of probable or definite stent thrombosis(30 days and 12 months)
- Duration of DAPT(30 days and 12 months)
Investigators
Study Sites (17)
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