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

Critical Limb Ischemia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03669458
Study type Interventional
Source ReFlow Medical, Inc.
Contact
Status Completed
Phase N/A
Start date October 6, 2017
Completion date June 4, 2019
View Details
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