NCT03551496

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Drug Eluting Stent - Below the Knee	Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm
DEVICE	Standard PTA Control Arm	The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.

Timeline

• Start date: 2018-08-31
• Primary completion: 2022-04-21
• Completion: 2023-12-20
• First posted: 2018-06-11
• Last updated: 2024-07-01
• Results posted: 2023-08-14

Locations

42 sites across 5 countries: United States, Belgium, France, Japan, Netherlands

Regulatory

• FDA-regulated device study