peripheral arterial disease /symptomatic primary atherosclerotic stenoses and occlusions of the superficial femoral artery (SFA)
Conditions
Interventions
treatment of symptomatic primary atherosclerotic stenoses and occlusions of the
superficial femoral artery (SFA)
Drug Eluting Scaffold
lower extrimities
Resorbable
Sponsors
Elixir Medical Corporation
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 2-4) A single, de novo native disease segment of the SFA
Exclusion criteria
Exclusion criteria: 1. Previous bypass surgery or stenting at the target leasion (TL) 2. Percutaneous or open surgical revascularization of the contralateral iliac or infrainguinal arteries *30 days prior to the planned index procedure. Iliac artery lesions may be treated during the index procedure if necessary for approach to the TL; 3. Failure to successfully cross the target lesion with a guide wire;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint is the composite of freedom from perioperative death (through 30-day follow-up) and freedom from major adverse limb events defined as the occurrence of major amputation, thrombectomy or thrombolysis, or major open surgical revascularization through 6-month follow-up The primary effectiveness endpoint is primary patency defined as freedom from restenosis (>50% diameter reduction defined by Duplex Ultrasound) or clinically driven target lesion revascularization through 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| * The composites for the primary safety and effectiveness endpoints will be tabulated through 12 months as secondary endpoints; * Technical success; defined at the conclusion of the index procedure as a) successful delivery and deployment of the study device, b) 2.4; * Target Lesion Revascularization (TLR) (all); * Clinically-driven TLR; * Target extremity revascularization; * Primary patency of the target lesion (TL); * Primary-assisted patency of the TL; * Secondary patency of the TL; * Rutherford-Becker clinical category; * Ankle brachial index (ABI) in the target extremity; * Walking capacity as demonstrated by Walking Impairment Questionnaire (WIQ) scores; * Quality of Life Measures using VASCUQOL (disease specific); * Duplex ultrasound-derived Peak Systolic Velocity (PSV) at the TL; * Binary restenosis as determined by duplex ultrasound PSVR >2.4. | — |
Countries
Belgium, Germany, Netherlands, New Zealand
Outcome results
None listed