Acute Coronary Syndrome, Angina Pectoris, Arterial Occlusive Diseases, Arteriosclerosis, Cardiovascular Diseases, Chest Pain, Coronary Artery Disease, Coronary Disease, Heart Diseases, Myocardial Ischemia, Neurologic Manifestations, Pain, Pathological Conditions, Signs and Symptoms, Signs and Symptoms, Vascular Diseases
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 resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience coronary drug-eluting stent (DES) system
Detailed description
The BIOMAG-III clinical trial is a prospective, international, multi-center, single-blinded, randomized controlled, non-inferiority trial to compare the Freesolve Sirolimus Eluting Coronary Resorbable Magnesium Scaffold (Freesolve RMS) System with the Xience Everolimus Eluting Stent (Xience DES) System. with respect to Target Lesion Failure (TLF) rate at 12 months. Subjects will be randomized in a 2:1 fashion Freesolve to Xience. A total of up to 1859 subjects will be randomized at up to 120 total sites worldwide including North America, Europe, and Asia Pacific. Clinical follow-up will be conducted at 1, 6, and 12 months and at 2, 3, 4, and 5 years post-procedure.
Interventions
DEVICEFreesolve RMS
Freesolve Sirolimus-Eluting Coronary Resorbable Magnesium Scaffold (RMS) System, a drug-eluting balloon-expandable resorbable scaffold
DEVICEXience DES
Xience Everolimus Eluting Stent System
Sponsors
Teleflex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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 Ethics Committee / 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 operator visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) / Intravascular Ultrasound (IVUS) / Optical Coherence Tomography (OCT) 3. Target lesion(s) must be ≤ 36 mm in length by operator visual estimation, which may be assisted by QCA / IVUS / OCT, (or \< 20 mm for target lesion(s) to be treated with a study device \< 3.0 mm in diameter) and must 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 |
|---|---|---|
| Target Lesion Failure (TLF) rate at 12 months post-index procedure | 12 months | The primary endpoint is Target Lesion Failure (TLF) at 12 months, a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven target lesion revascularization (TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure (TLF) | Time Frame: 1, 6 months and 2, 3, 4 and 5 years post-index procedure | TLF is defined as a composite of Cardiac Death, Target Vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven Target Lesion Revascularization (TLR) |
| Target Vessel Failure (TVF) | 1, 6, 12 months and 2, 3, 4 and 5 years post-index procedure | Target Vessel Failure (TVF), a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven Target Vessel Revascularization (TVR) |
| Cardiac death | 1, 6, 12 months and 2, 3, 4 and 5 years post-index procedure | — |
| Cardiovascular death | 1, 6, 12 months and 2, 3, 4 and 5 years post-index procedure | — |
| All-cause mortality | 1, 6, 12 months and 2, 3, 4 and 5 years post-index procedure | — |
| Target vessel MI in accordance with the primary endpoint definitions for periprocedural and non-periprocedural MI | 1, 6, 12 months and 2, 3, 4 and 5 years post-index procedure | — |
| Any MI (including non-target vessel territory) | 1, 6, 12 months and 2, 3, 4 and 5 years post-index procedure | — |
| Clinically driven TLR | 1, 6, 12 months and 2, 3, 4 and 5 years post-index procedure | — |
| Clinically driven TVR | 1, 6, 12 months and 2, 3, 4 and 5 years post-index procedure | — |
| Scaffold/stent thrombosis (definite, definite/probable, probable) according to Academic Research Consortium (ARC-2) criteria for acute, sub-acute, late, very late and cumulative scaffold/stent thrombosis | 1, 6, 12 months and 2, 3, 4 and 5 years post-index procedure | — |
| Powered Secondary Endpoint 1: TLF from 1-5 Years | 1 to 5 years post-index procedure | A powered secondary endpoint of cumulative TLF rates between 1 and 5 years post-procedure will be evaluated. |
| Powered Secondary Endpoint 2: TLF at 12 Months in the Diabetic Population | 12 months post-index procedure | A powered secondary endpoint of TLF at 12 months in the diabetic population will be evaluated. |
| Device Success | Hospital Discharge (6-24 hours post-index procedure) | Device Success defined as a final residual diameter stenosis of \< 30% by QCA or visual estimation, using the assigned device only with * successful delivery of the device to the target lesion, and * appropriate device deployment, and * successful removal of the delivery system |
| Procedure success | Hospital Discharge (6-24 hours post-index procedure) | Procedure success defined as achievement of \< 30% final residual diameter stenosis \[by Quantitative Coronary Angiography (QCA) or visual estimation\] of the target lesion using the assigned study device only, without the occurrence of cardiac death, Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion during the hospital stay |
Countries
Latvia, United States
Contacts
CONTACTBIOMAG-III Project Manager
Outcome results
None listed