Trials / Not Yet Recruiting
Not Yet RecruitingNCT07258290
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions
Safety and Clinical Performance of the Drug Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,859 (estimated)
- Sponsor
- Teleflex · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Coronary Disease
- Heart Diseases
- Cardiovascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Vascular Diseases
- Chest Pain
- Pain
- Neurologic Manifestations
- Signs and Symptoms
- Pathological Conditions, Signs and Symptoms
- Coronary Artery Disease
- Myocardial Ischemia
- Acute Coronary Syndrome
- Angina Pectoris
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Freesolve RMS | Freesolve Sirolimus-Eluting Coronary Resorbable Magnesium Scaffold (RMS) System, a drug-eluting balloon-expandable resorbable scaffold |
| DEVICE | Xience DES | Xience Everolimus Eluting Stent System |
Timeline
- Start date
- 2026-05-01
- Primary completion
- 2029-06-01
- Completion
- 2033-06-01
- First posted
- 2025-12-02
- Last updated
- 2025-12-02
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07258290. Inclusion in this directory is not an endorsement.