NCT03669458

Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.

A Non-RandomizeD FEasibility Trial of the Spur SystEm for the Treatment of Lesions in the InfraPoplitEal ArteRy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: ReFlow Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of the Spur System in a patient population with infrapopliteal artery disease (tibioperoneal, anterior/posterior tibial and peritoneal arteries) when used in conjunction with substance/drug coated balloons.

Detailed description

The objective of this study is to perform a prospective, multi-center (min 2 sites), non-randomized study to evaluate the safety and efficacy of the Spur system and compare treatments arms (if applicable) in treating subjects with infrapopliteal disease who are at risk for amputation. The study protocol will ensure consistency in performing the procedure, patient management and results of the procedure. Safety and efficacy will be evaluated during index procedure through one (1) year follow up

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
DEVICE	Below the Knee peripheral intervention	Treatment of infrapopliteal disease using SPUR/DCB, SPUR only and DCB alone

Timeline

• Start date: 2017-10-06
• Primary completion: 2019-06-04
• Completion: 2019-06-04
• First posted: 2018-09-13
• Last updated: 2020-08-20

Locations

1 site across 1 country: Dominican Republic

Regulatory

• FDA-regulated device study