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

Elixir Medical Corporation5,000 enrolled

Overview

The goal of this registry is to confirm the safety, and performance of the DynamX Coronary Bioadaptor System in patients with coronary artery disease.

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 Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Coronary Artery Disease

Interventions

DynamX Novolimus-eluting Coronary Bioadaptor SystemDEVICE

All patients will receive at least one DynamX Bioadaptor implant in a commercial setting in accordance with the product's Instructions for Use

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

University Hospital St. Pölten

Pölten, Austria

RECRUITING

Curaçao Medical Center

Willemstad, Curacao

Outcomes

Primary Outcomes

Device Oriented Clinical Endpoint

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

Time frame: 12 Months

Secondary Outcomes

Clinical Device Success

Achievement of a final residual stenosis \<30% by QCA or visual estimation, using the study device and without a device deficiency

Time frame: In-Hospital, assessed up to 7 days after procedure

Clinical Procedural Success

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

Time frame: In-Hospital, assessed up to 7 days after procedure

Device Oriented Clinical Endpoint

Composite of TLF: cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR), per ARC-2

Time frame: 30 days

Patient Oriented Clinical Endpoint

Composite of all-cause death, any stroke, any myocardial infarction (MI) (includes non-target vessel territory) and any revascularization.

Time frame: 30 days and 12 months

Rate of target vessel failure (TVF)

Composite of cardiovascular death, TV-MI, or target vessel revascularization (TVR).

Time frame: 30 days and 12 months

Rate of all revascularization

Target lesion, target vessel, non-target lesion, non-target vessel; clinically driven and non-clinically driven.

Central Contacts

Lisa Tanner

CONTACT

+1 408 636 2000 ltanner@ElixirMedical.com

Elizabeth Lau, PhD

CONTACT

elau@ElixirMedical.com

Data from ClinicalTrials.gov

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