X-TOSI - Concept Medical
X-TOSI

OBJECTIVE

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

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

Phase 2, Prospective, All-comers, Single arm, Pilot study

Study Endpoints:

Primary Endpoints:
• Primary patency, defined as by duplex ultrasonography-derived peak systolic velocity ratio of ≤ 2.4 [Time frame: 6 months]
• SAFETY: Freedom from Major Adverse Events (MAE) [Time Frame: 6 months] 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, 12 and 24 months]
• Freedom from clinically-driven Target Vessel Revascularization (TVR) [Time Frame: 6, 12 and 24 months]
• Primary patency [Time Frame: 12 and 24 months]
• Freedom from MAE [Time Frame: 12 and 24 months]
• Amputation-free survival [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].
• Procedural success is technical and device success without the occurrence of any major adverse events during the hospital stay.

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