NCT06122974

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 518 (estimated)
• Sponsor: ReFlow Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
DEVICE	Drug Eluting Temporary Spur Stent System	The Spur Stent consists of a sirolimus coated stent and balloon that is retrievable after delivery of the sirolimus formulation.
DEVICE	Percutaneous Transluminal Balloon Angioplasty	A balloon catheter is inserted across a lesion and inflated to fracture and compress the plaque, creating a larger lumen and improved blood flow through the artery.

Timeline

• Start date: 2026-08-01
• Primary completion: 2032-06-01
• Completion: 2037-12-01
• First posted: 2023-11-08
• Last updated: 2026-01-07

Regulatory

• FDA-regulated device study