OBJECTIVE

Xtreme Touch - Neo sirolimus coated PTA balloon catheter in the treatment of infrainguinal arteries

  • Principal Investigator
    Prof. Edward Choke
    Sengkang General Hospital, Singapore
STUDY DESIGN

Observational, Prospective, All-comers, Single Arm, Real-world Registry

Study Endpoints:

Primary Endpoints:
• EFFICACY: Freedom from clinically-driven Target Lesion Revascularization (TLR) [Time Frame: 12 months]
• SAFETY: Freedom from Major Adverse Events (MAE) [Time Frame: 30 days] A composite of freedom from device- and procedure-related mortality, and major target limb amputation through to 30 days, and freedom from clinically driven target lesion revascularization (TLR) within 6 months post-index procedure.

Secondary Endpoints:
• Freedom from clinically-driven TLR [Time Frame: 6 and 24 months]
• Freedom from clinically-driven Target Vessel Revascularization (TVR) [Time Frame: 6 and 24 months]
• Primary patency [Time Frame: 12 and 24 months]
• Freedom from MAE [Time Frame: 12 and 24 months]
• Change in mean Ankle Brachial Index [Time Frame: 6, 12 and 24 months]
• Amputation-free survival [Time Frame: 6, 12 and 24 months]
• Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire [Time Frame: 6, 12 and 24 months]
• Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification [Time Frame: 6, 12 and 24 months]
• Device success [Time Frame: Day 0]
• Successful delivery, inflation, deflation, and retrieval of the Xtreme Touch – Neo balloon catheter.
• Technical success [Time Frame: Day 0]
• Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation
• Procedural success [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1-2 days].

X-TOSI First in Man Clinical Trial (Interim Analyses)
High clinical severity and technical difficulty
CLINICAL OUTCOMES