NCT05161039

Serranator Recoil Study

Recoil Feasibility Study for the Treatment of Atherosclerotic Lesions in the Infrapopliteal Arteries Comparing Serration Angioplasty (Serranator® Device) vs. Plain Balloon Angioplasty (POBA)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cagent Vascular LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection will be collected.

Detailed description

Multi-center, feasibility study treating up to 20 atherosclerotic lesions in the infrapopliteal arteries. The study will capture angiographic imaging (pre, during, post, and post 15 mins) for all lesions, and a subset (up to 10) of IVUS imaging data (pre, post, and post 15 mins), to compare serration angioplasty vs standard angioplasty and its effects on vessel recoil and final diameter stenosis.

Conditions

• Peripheral Arterial Disease
• Critical Limb Ischemia

Interventions

Type	Name	Description
DEVICE	Serranator	Serranator® PTA Serration Balloon Catheter manufactured by Cagent Vascular
DEVICE	POBA	Plain balloon angioplasty device

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2021-12-16
• Last updated: 2022-06-09

Locations

2 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study