Randomized clinical trial (RCT) comparing outcomes of the DynamX Sprint BTK Bioadaptor to Percutaneous Transluminal Angioplasty (PTA) for the treatment of Below the Knee (BTK) infrapopliteal arteries.
Sponsor
Elixir Medical Corporation, USA
Study objectives
To evaluate the safety and effectiveness of the DynamX Sprint BTK Bioadaptor as compared to PTA in subjects with chronic limb ischemia (CLI) undergoing percutaneous revascularization of the infrapopliteal arteries.
Primary endpoints
Primary Efficacy Endpoint: Primary Patency at 6 months [freedom from 100% total occlusion of target lesion as measured by Duplex Ultrasound and clinically driven target lesion revascularization (CD-TLR)], noninferiority to control.
If the above non-inferiority is met, then test for superiority on the minimal lumen diameter (MLD) measured from angiography in the imaging substudy at 6 months.
Primary Safety Endpoint: Freedom from Major Adverse Limb Event
(MALE) at 6 months and Peri-Operative Death (POD) at 30 days.
CERC Services
- Angiography and Doppler Ultrasound analysis (Corelab activities)
Countries
Sweden
Number of investigational sites
12
