OBJECTIVE

Safety And Efficacy Of XtremeTouch Neo SCB Catheter In De-novo/Restenotic Lesions In Superficial Femoral And Below The Knee Peripheral Artery Disease

  • Principal Investigator
    Dr. Sameer Dani
    Life Care Institute of Medical Sciences and Research, India
STUDY DESIGN

Multi-centre, Prospective, Pilot study assessing the safety and efficacy of XtremeTouch Neo Sirolimus Coated PTA Balloon catheter system in superficial femoral and below the knee peripheral artery disease.

Study Endpoints:

Primary Endpoints:
• Efficacy: Freedom from target lesion revascularization (TLR) (Time Frame: 6 months)
• Safety (Time Frame: 30 Days): Freedom from the composite endpoint of target vessel, revascularization (TVR), major amputation and major re-intervention (new bypass graft, jump/interposition graft revision or thrombectomy/thrombolysis) of index limb and device- and procedure-related death

Secondary Endpoints:
• Procedural success to pass and treat the lesions (remaining stenosis is 30 %)
• Primary patency (freedom from total occlusion) (Time Frame: 6, 12 and 24 months)
• Clinically-driven TLR (Time Frame: 12 and 24 months)
• Target vessel revascularization (TVR) (Time Frame: 1, 6, 12 and 24 months)
• Death (all cause) (Time Frame: 1, 6, 12 and 24 months)
• Unexpected device or drug-related AEs (Time Frame: 1, 6, 12 and 24 months)
• Index limb amputation (major and minor reported separately)
• Change in Rutherford Class (target limb) (Time Frame: 6 and 12 months, composite of all cause
• Perioperative (≤30 day) death and from the following: index limb amputation, index limb re-intervention and index-limb-related death.
• Ankle-Brachial index (ABI) score assessment (Time Frame: 1, 6, 12 and 24 month).
• Myocardial Infarction (Time frame: 12 and 24 months)
• Stroke (Time frame: 12 and 24 months)

BASELINE, LESION AND PROCEDURE CHARACTERISTICS
CLINICAL OUTCOMES