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Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia — DEEPER RCT  

Critical Limb Ischemia Clinical Trial

Official title:
A RanDomized Controlled Trial of the Drug Eluting TEmporary Spur StEnt System vs PERcutaneous Balloon Angioplasty for the TReatment of CriTical Limb Ischemia

Clinical Trial Summary

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.

Clinical Trial Description

This is a randomized controlled trial evaluating the safety and efficacy of the Drug Eluting Temporary Spur Stent System (Spur) compared to percutaneous transluminal balloon angioplasty (PTA). The trial will be conducted in two phases. Phase A is a prospective, multi-center, 1:1 randomized dual arm study of 20 subjects, evaluating the short-term safety of the Drug Eluting Temporary Spur Stent System compared to PTA to treat lesions in infrapopliteal arteries in subjects with critical limb ischemia (CLI). Thirty (30) day data from Subjects in Phase A will be evaluated by an independent Data Safety Monitoring Board (DSMB) and submitted to the Food and Drug Administration (FDA) for review. Phase A subjects will be rolled into Phase B. Phase B is a prospective, multicenter, 1:1 randomized dual arm study of no less than 345 and up to 518 subjects, evaluating the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA to treat lesions in infrapopliteal arteries in subjects with CLI. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06122974
Study type Interventional
Source ReFlow Medical, Inc.
Contact Carolyn Mascho, BSN, DNP, AG-NP
Phone 616-802-8575
Email cmascho@reflowmedical.com
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date December 2035
View Details
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