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The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia — SAVAL  

Critical Limb Ischemia Clinical Trial

Official title:
A Randomized Trial Comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia

Clinical Trial Summary

Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).

Clinical Trial Description

A global, prospective, multicenter, 2:1 randomized trial evaluating the safety and effectiveness of the DES BTK Vascular Stent System compared to standard percutaneous transluminal angioplasty to treat infrapopliteal artery lesions in subjects with critical limb ischemia(CLI). Approximately 201 subjects will be randomized/enrolled to support a 2:1 randomization. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03551496
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase Phase 3
Start date August 31, 2018
Completion date December 20, 2023
View Details
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