Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Teleflex
Study ID
NCT07258290
Status
Recruiting
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Conditions

  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Freesolve RMS — DEVICE
    Freesolve Sirolimus-Eluting Coronary Resorbable Magnesium Scaffold (RMS) System, a drug-eluting balloon-expandable resorbable scaffold
  • Xience DES — DEVICE
    Xience Everolimus Eluting Stent System

Study Details

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

Key Dates

Start date
Jun 11, 2026
Status verified
Nov 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2033

Study Design

Enrollment
1,859 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Freesolve RMS
    Intervention with a Freesolve Sirolimus Eluting Coronary Resorbable Magnesium Scaffold (RMS) System
  • Active Comparator: Xience DES
    Intervention with a Xience Everolimus Eluting Stent System

Primary Outcome Measure

Target Lesion Failure (TLF) rate at 12 months post-index procedure [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-

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MedStar Washington Hospital Center· Washington D.C., DC

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