Critical Limb Ischemia peripheral artery disease
Conditions
Interventions
Test device : The DES BTK Vascular Stent System for treatment of lesions in the
infrapopliteal arteries.
Control device: Percutaneous Transluminal Angioplasty (PTA) balloon catheter.
For additional
Sponsors
Boston Scientific Cooperation International
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Pre-procedure Inclusion Criteria 1. Subject is 18 years or older and has signed and dated the trial informed consent form (ICF). Note: For subjects in Japan who are less than 20 years of age, the subject*s legal representative must provide written informed consent in addition to the subject 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 categories 4 or 5 in the target limb, with wound(s) confined to toes/forefoot 4. Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active must be using, or agree to use, a medically- acceptable method of birth control as confirmed by the investigator Intra-Procedure Inclusion Criteria 1. Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies). • Target lesion(s) must be at least 4cm above the ankle joint • A single target lesion per vessel, in up to 2 vessels, in a single limb • Degree of stenosis >= 70% by visual angiographic assessment • Reference vessel diameter (RVD) is between 2.5 - 3.25mm for phase A RCT • Total target lesion length (or series of lesion segments) to be treated is
Exclusion criteria
Exclusion criteria: Pre-Procedure Exclusion Criteria 1. Life expectancy = 600 X 103/µL 2 target vessels (Note: a target lesion originating in one vessel and extending into another vessel is considered 1 target vessel) 3. Treatment requires the use of alternate therapy in the target vessel(s)/lesion(s), (eg, atherectomy, cutting balloon, re-entry devices, laser, radiation therapy) 4. Aneurysm is present in the target vessel(s) 5. Extremely calcified lesions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Effectiveness Endpoint (Phase A RCT) The primary effectiveness endpoint assesses primary patency at 12 months post-procedure. This effectiveness endpoint is designed to demonstrate that the 12-month primary patency for the DES BTK treatment group is superior to the PTA treatment group at an overall one-sided significance level of 2.5%. Primary vessel patency is defined as a binary endpoint to be determined via duplex ultrasound (DUS) measuring flow or no flow at the 12-month follow-up visit in the absence of clinically-driven target lesion revascularization (TLR) or bypass of the target lesion. All DUS readings will be assessed by an independent core laboratory. Primary Safety Endpoint (Phase A RCT) The primary safety endpoint assesses major adverse events (MAE) at 12 months post-procedure. This safety endpoint is designed to demonstrate that the 12-month MAE-free rate for the DES BTK treatment group is non-inferior to the PTA treatment group at an overall one-sided significance level of 2.5%. A major adverse event is defined as the composite of: • Above ankle amputation of the index limb • Major re-intervention (ie, new bypass graft, jump/interposition graft, or thrombectomy/thrombolysis) • Perioperative (30 day) mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional Endpoints Phase A: • Primary and assisted-primary patency at 1, 6, 12, 24, and 36 months post-procedure • Clinically-driven target lesion revascularization (TLR) rate at each time point • Hemodynamic outcomes (changes in Ankle-Brachial Index [ABI] and/or Toe-Brachial Index [TBI]) at 6 and 12 months post procedure • Wound assessment (changes in wound characteristics) • Major amputation rate • Change in Rutherford classification at 3, 6, 12, 24, and 36 months post procedure • Quality of Life (QOL) changes at 1, 3, 6 and 12 months post procedure • Adverse events (AEs) at each time point (to be classified as major, serious, non-serious, unanticipated, procedure-related and device-related) • 30-day unplanned hospital readmission rate | — |
Countries
Netherlands
Outcome results
None listed