Status: Not yet recruiting
Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia
The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA. The Drug Eluting Temporary Spur Stent System is intended for use as a primary treatment in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.
Participants needed: 518
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: ReFlow Medical, Inc.Updated: Jan 7, 2026
Eligibility criteria
Subject willing and able to provide informed consent and able to comply with the... [+25]
Subject unwilling or unlikely to comply with the 5-year duration of the study in... [+25]