Last updated on May 2019

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


Brief description of study

Two 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).

Detailed Study Description

Phase A: 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). Phase A RCT will begin with one size of the device: 3.5 mm x 80 mm.

Phase B: A global, prospective, multicenter, non-randomized trial collecting additional safety and effectiveness data for the DES BTK Vascular Stent System to treat infrapopliteal artery lesions in subjects with CLI. Additional stent sizes will be added to the trial upon regulatory approval.

Approximately 201 subjects will be randomized/enrolled to support a 2:1 randomization in the phase A RCT. Assuming the effectiveness endpoint is met in phase A RCT, approximately 100 additional subjects are expected to be enrolled in phase B non-randomized which is structured as a single arm where the enrolled subjects are treated with the DES BTK Vascular Stent System.

Clinical Study Identifier: NCT03551496

Find a site near you

Start Over

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.