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 an investigational device being studied for the treatment of Critical Limb Ischemia, a severe form of peripheral artery disease. It is designed to be placed in arteries below the knee to help restore blood flow. The device is currently in Phase 3 clinical development.
Drug Eluting Stent- Below the Knee is being developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker BSX. The company is conducting clinical trials to evaluate the safety and effectiveness of this stent system for 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 regulatory authorities. The Phase 3 trial has been completed, with results expected to inform potential future regulatory submissions.
Drug Eluting Stent- Below the Knee has one completed Phase 3 clinical trial registered as NCT03551496. This trial, titled 'The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia,' enrolled 201 participants across the United States, Belgium, France, Japan, and the Netherlands.
Drug Eluting Stent- Below the Knee is also known as DES BTK, which stands for Drug Eluting Stent Below the Knee. The clinical trial NCT03551496 refers to it as the 'DES BTK Vascular Stent System.' Both names refer to the same investigational device developed by Boston Scientific.