Acute Coronary Syndrome, Angina Pectoris, Atherosclerosis, Coronary, Coronary Artery Disease, Ischemic Heart Disease, Myocardial Ischemia
Conditions
Keywords
Resorbable Magnesium Scaffold, Sirolimus, RMS, Drug eluting absorbable metal scaffold
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.
Interventions
DEVICEFreesolve RMS
Subject undergoes implantation of Freesolve RMS
DEVICEXience DES
Subject undergoes implantation of Xience DES
Sponsors
Biotronik AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: 1. Subject is ≥ 18 years and ≤ 80 years of age 2. 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 3. Subject is eligible for PCI according to the applicable guidelines 4. Subject is an acceptable candidate for coronary artery bypass surgery 5. 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) 6. Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine 7. Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization) 8. Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study Angiographic Inclusion Criteria: 1. Subjects with a maximum of two single de novo target lesions each in separate native coronary arteries 2. Target vessel must have a reference diameter between 2.5-4.2 mm by visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) / Intravascular Ultrasound (IVUS) / Optical Coherence Tomography (OCT) 3. Target lesion must be ≤28mm in length by operator visual estimation, which may be assissted by QCA / IVUS / OCT, (or \< 20 mm for target lesion(s) to be treated with a study device \< 3.0 mm in diameter) and should be amenable to treatment with a single study device 4. Target lesion stenosis ≥ 50% and \< 100% by operator visual estimation, which may be assisted by QCA / IVUS / OCT. Target lesion stenosis \< 70% by visual estimation, should have clinical justification for treatment as per local standards. 5. Target lesion must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥1 Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure | 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). |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORMichael Haude, MD
Rheinland Klinikum Neuss GmbH Lukaskrankenhaus Neuss
Outcome results
None listed