Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03551496 | The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia | PHASE3 | COMPLETED | 201 | — | — | Aug 31, 2018 | Dec 20, 2023 | Jul 1, 2024 | 42 | United States, Belgium +3 |
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...