BIOMAG-IIINCT07258290
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions
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Record History
All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗
- Notable Eligibility criteria expanded, about 22 words
- Trial sites expanded: 3 → 7 locations
- Secondary endpoints: details revised at 3 of 14 entries
- Minor Study sites: 2 to 3v4
- Minor Study sites: 1 to 2v3
- Notable Trial status: Not Yet Recruiting to Recruiting
- Study sites: 0 to 1
- Start date changed from estimate of May 2026 to Jun 11, 2026
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Target Lesion Failure (TLF) rate at 12 months post-index procedure
Timeframe: 12 months
Secondary (14)
Procedure success
Device Success
Target lesion failure (TLF)
Target Vessel Failure (TVF)
Cardiac death
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Cardiovascular death
All-cause mortality
Target vessel MI in accordance with the primary endpoint definitions for periprocedural and non-periprocedural MI
Any MI (including non-target vessel territory)
Clinically driven TLR
Clinically driven TVR
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
Powered Secondary Endpoint 1: TLF from 1-5 Years
Powered Secondary Endpoint 2: TLF at 12 Months in the Diabetic Population
Arms and interventions
Freesolve RMSExperimental
Intervention with a Freesolve Sirolimus Eluting Coronary Resorbable Magnesium Scaffold (RMS) System
Xience DESActive comparator
Intervention with a Xience Everolimus Eluting Stent System
Devices: Freesolve RMS, Xience DES
Sites
7 sites in 4 countries
United States 4, France 1, Latvia 1, Poland 1