Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Drug Eluting Stent- Below the Knee · 1 trial · 1 indication
Twelve-Month Primary Patency defined as a binary endpoint to be determined via duplex ultrasound (DUS) measuring flow at the 12-month follow-up visit, in the absence of clinically-driven target lesion revascularization (TLR) or bypass of the target lesion. Data table consists of the number of participants with flow as assessed by DUS.
The primary safety endpoint assesses freedom from major adverse events (MAE) at 12 months post-procedure. (MAE is defined as: above ankle amputation in index limb; major re-intervention; and perioperative (30 day) mortality)
| Arm | Type | Description |
|---|---|---|
| DES BTK | EXPERIMENTAL | Treatment with DES BTK |
| Conventional PTA | ACTIVE_COMPARATOR | Treatment with standard PTA |
| Name | Type | Description |
|---|---|---|
| Drug Eluting Stent - Below the Knee | COMBINATION_PRODUCT | Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm |
| Standard PTA Control Arm | DEVICE | 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. |
Inclusion Criteria: 1. Subject is 18 years or older and has signed and dated the trial informed consent form (ICF) 2. Subject is willing and able to comply with the trial testing, procedures and follow-up schedule 3. Subject has chronic, symptomatic lower limb ischemia, determined by Rutherford cat...
Drug Eluting Stent - Below the Knee is a stent system being developed for the treatment of critical limb ischemia, a severe form of peripheral artery disease. It is designed for use below the knee in patients with this condition and is being studied in a Phase 3 clinical program.
Drug Eluting Stent - Below the Knee is being developed by Boston Scientific Corporation, which trades on the New York Stock Exchange under the ticker BSX. The company is the sponsor of the clinical program evaluating this stent system in patients with critical limb ischemia.
Drug Eluting Stent - Below the Knee is in Phase 3 clinical development. It is an investigational device and has not been approved by the FDA. The Phase 3 trial evaluating it has been completed, and the program is not currently listed with any active trials.
Drug Eluting Stent - Below the Knee was evaluated in the Phase 3 trial NCT03551496, titled The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia. The trial enrolled 201 participants across the United States, Belgium, France, Japan, and the Netherlands, and it has been completed.
The Phase 3 trial NCT03551496 for Drug Eluting Stent - Below the Knee was a randomized, active-controlled study comparing the stent system with percutaneous transluminal angioplasty in patients with critical limb ischemia. It enrolled 201 participants aged 18 years and older and was conducted across five countries.
Yes, Drug Eluting Stent - Below the Knee and Drug Eluting Stent- Below the Knee refer to the same Boston Scientific stent system being studied for critical limb ischemia. The two spellings are alternative names for the same investigational device in the Phase 3 program.