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

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT06074549
• Lead Sponsor: Elixir Medical Corporation

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.

Study Timeline

• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-10
• Study Start: 2024-03-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Clinical Procedural Success	In-Hospital, assessed up to 7 days after procedure	Achievement of a final residual stenosis \<30% by QCA or visual estimation, using the study device, with or without any adjunctive devices, and without TLF
Device Oriented Clinical Endpoint	30 days	Composite of TLF: cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR), per ARC-2
Rate of target vessel failure (TVF)	30 days and 12 months	Composite of cardiovascular death, TV-MI, or target vessel revascularization (TVR).
Rate of all revascularization	30 days and 12 months	Target lesion, target vessel, non-target lesion, non-target vessel; clinically driven and non-clinically driven.
Rate of all-cause death	30 days and 12 months	Cardiovascular, Non-Cardiovascular, Unknown
Clinical Device Success	In-Hospital, assessed up to 7 days after procedure	Achievement of a final residual stenosis \<30% by QCA or visual estimation, using the study device and without a device deficiency
Patient Oriented Clinical Endpoint	30 days and 12 months	Composite of all-cause death, any stroke, any myocardial infarction (MI) (includes non-target vessel territory) and any revascularization.
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
Rate of all MI	30 days and 12 months	Target and non-target vessel

Trial Locations

Locations (1)

King Fahad Armed Forces Hospital; 🇸🇦 Jeddah, Saudi Arabia