BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve®) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries: BIOMAG-II: A Randomized Controlled Trial

Biotronik AG1 site in 1 country1,859 target enrollmentMay 13, 2024

ConditionsCoronary Artery Disease Atherosclerosis, Coronary Myocardial Ischemia Ischemic Heart Disease Acute Coronary Syndrome Angina Pectoris

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Biotronik AG
Enrollment: 1859
Locations: 1
Primary Endpoint: Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to assess the safety and efficacy of the Freesolve in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).

Detailed Description

The Biotronik BIOMAG-II clinical trial is a prospective, international, multi-center, randomized controlled, non-inferiority trial to compare the BIOTRONIK Sirolimus Eluting Resorbable Magnesium Scaffold System (Freesolve RMS) with the Xience Everolimus Eluting Stent System (Xience DES) with respect to Target Lesion Failure (TLF) rate at 12 months. A total of 1859 subjects will be enrolled at approximately 100 study sites Europe and APAC. Subjects will be randomized in a 2:1 ratio to Freesolve or Xience. Clinical follow-up visits will take place at 1, 6, 12 and at 2-, 3-, 4- and 5-years post procedure.

Registry

clinicaltrials.gov

Start Date

May 13, 2024

End Date

February 1, 2032

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biotronik AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is ≥ 18 years and ≤ 80 years of age
•Subject has provided written informed consent as approved by the Independent Ethical Committee (IEC) or Institutional Review Board (IRB) of the respective clinical site prior to the study related procedures
•Subject is eligible for PCI according to the applicable guidelines
•Subject is an acceptable candidate for coronary artery bypass surgery
•Subjects with stable or unstable angina pectoris, documented silent ischemia/abnormal physiologic testing or hemodynamically stable non-ST elevation myocardial infarction (NSTEMI) patients without angiographic evidence of thrombus at target lesion
•Note: STEMI patients may be eligible for the study for treatment of selected non-culprit lesions, if:
•Subject and target lesion(s) meet all inclusion and no exclusion criteria and consent occurs at least ≥ 72 hours after successful treatment of the culprit lesion(s) \[lesion(s) causing the acute STEMI\];
•Subject is hemodynamically stable with documented declining cardiac biomarkers;
•Target lesion(s) to be treated are not located in the culprit vessel(s) and are not culprit lesion(s)
•Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine

Exclusion Criteria

•Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
•Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with STEMI \< 72 hours prior to the index procedure.
•Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.
•Subject has undergone prior PCI within the target vessel during the last 12 months prior to the index procedure or prior PCI within a non-target vessel \<72 hours prior to the index procedure if successful and uncomplicated
•Subject is on dialysis or with impaired renal function (serum creatinine \> 2.5 mg/dL or 221 µmol/L, determined within 72 hours prior to the index procedure)
•Subject has a known allergy to contrast medium that cannot be adequately premedicated, or any known allergy to aspirin, P2Y12 inhibitors, both heparin and bivalirudin, sirolimus, everolimus (or similar limus drugs), poly L-lactide, the scaffold material (magnesium, aluminium, tantalum), or Xience stent material (cobalt, chromium, tungsten, nickel, -methacrylic polymer, and fluoropolymer)
•Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted)
•Life expectancy less than 1 year
•Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained
•In the investigator's opinion subject will not be able to comply with the follow-up requirements

Outcomes

Primary Outcomes

Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure

Time Frame: 12 Months

The primary endpoint will be Target Lesion Failure (TLF) at 12 months. TLF is a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven Target Lesion Revascularization (TLR).