Study Comparing DES BTK Vascular Stent System against PTA (H-43282)
The purpose of this study is to compare the safety and effectiveness of the DES BTK Vascular Stent System to percutaneous transluminal angioplasty (PTA). This is a surgical procedure using a thin tube with a tiny inflatable balloon for the treatment of blocked or narrowed blood vessels in the lower leg. The DES BTK stent is an investigational device. This means the device cannot be used or sold commercially. This study will evaluate the safety and effectiveness of the stent to open and prevent the re-narrowing of lower leg blood vessel(s). The PTA procedure that may be performed by a doctor is not investigational. The balloon catheters that will be used for the study are approved for commercial use for the treatment of narrowed or blocked blood vessels in the lower leg.
18 years or older
Chronic, lower limb ischemia, Rutherford 4 or 5
Stroke < 90 days
Patients with renal failure
Patients with coronary artery disease
Patients on immunotherapy, chemotherapy or steroids.
Known allergies to stents.