Acute Coronary Syndromes, Angina Pectoris, Atherosclerosis of Coronary Artery, Coronary Artery Disease, Ischemic Heart Disease, Myocardial Ischemia
Conditions
Keywords
Resorbable Magnesium Scaffold, Sirolimus, RMS, Drug eluting absorbable metal scaffold
Brief summary
The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.
Detailed description
In the study presented here, an extension of the Freesolve size range (35 and 40 mm scaffold length) will be investigated with the aim of assessment the safety and clinical performance of 35 and 40 mm Freesolve in de novo coronary artery lesions up to 38 mm in length to support CE certification of these sizes. BIOMAG-LL is a pre-marketing study. It is a prospective, international, multi-center, single arm trial. The primary endpoint of the study will be Target Lesion Failure (TLF) rate at 12 months. Clinical follow-up will be conducted at 1, 6, 12, 36, and 60 months post-procedure. The total duration of the study is approximately six and a half years, including the fifteen-month recruitment phase and the five-year follow-up period. A sample size of 100 patients is expected. In addition, it is intended to conduct a pharmacokinetic substudy. The objective of this substudy is to describe the pharmacokinetics of sirolimus delivered by Freesolve. For this purpose, 15 patients will be prospectively enrolled in the substudy with a whole blood sample collected up to seven days after the procedure.
Interventions
Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold
Sponsors
Biotronik AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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, cangrelor or ticlopidine 7. Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to enrollment) 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 2.7-4.2 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 \>28 mm and ≤ 38 mm in length by operator visual estimation, which may be assisted by QCA / IVUS / OCT, 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
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, Hungary, Italy, Latvia, Poland, Spain, Switzerland
Contacts
CONTACTBarbara Widmann, PhD
PRINCIPAL_INVESTIGATORFlavio Luciano Ribichini, Prof. Dr.
Azienda Ospedaliera Universitaria Integrata Verona
Outcome results
None listed