BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Resorbable MAGnesium Scaffold (Freesolve) in the Treatment of Subjects With Long de Novo Lesions in Native Coronary Arteries: BIOMAG-LL

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

‣ Clinical 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, cangrelor or ticlopidine

• Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to enrollment)

• Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study

‣ Angiographic Inclusion Criteria

• Subjects with a maximum of two single de novo target lesions each in separate native coronary arteries

• 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)

• 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

• 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.

• Target lesion must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥1

Locations
Other Locations
Germany
Klinikverbund Allgäu gGmbH
RECRUITING
Immenstadt Im Allgäu
Italy
Azienda Ospedaliera Universitaria Integrata Verona
NOT_YET_RECRUITING
Verona
Latvia
Pauls Stradins Clinical University Hospital
RECRUITING
Riga
Contact Information
Primary
Barbara Widmann, PhD
barbara.widmann@biotronik.com
0041 75 429 5530
Time Frame
Start Date: 2025-02-18
Estimated Completion Date: 2031-06
Participants
Target number of participants: 100
Treatments
Experimental: Treatment
All subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve 35- and 40-mm scaffold) and followed up until 60 months.
Sponsors
Leads: Biotronik AG

This content was sourced from clinicaltrials.gov