Clinical Studies

EX VIVO EXPERIMENTS

PROTOCOL
  • Experiments were performed on human amputated legs obtained from patients with documented peripheral vascular disease (PVD). The fresh human amputation, either below knee (BK) or above knee (AK), was provided directly post surgery.
  • After a failed 10 minute attempt to cross with a standard guidewire, the CiTop™ guidewire was introduced and attempted to cross occlusion. The CiTop™ guidewire working element was expanded, advancing in steps inside the target segment.
  • The CiTop™ guidewire was retrieved out of the amputation and post-procedure angiography was recorded to evaluate flow and potential arterial damage.

                                        
                                  Figure 1 - CTO harvested for histopathology
    RESULTS

  • Occlusion average length ranged between 9mm to 104mm with an average occlusion length of 30.6±26.7mm, and arterial diameter ranged between 2.2mm to 6.8mm with mean diameter of 3.1±1.2mm.

  • Average time to cross the occlusion was 3.5±4.6 minutes.

  • In 14 cases (93.3%) the CiTop™ guidewire successfully passed the occlusions resulting with angiographic evidence of occlusion filling, and without significant histological evidence of arterial damage).

  • The treated arterial segment distribution was: 5 tibialis anterior, 5 tibialis posterior, 2 peroneal arteries, 2 popliteal arteries and 1 SFA. 

                     

                             Figure 2 - Histopathology after CiTop™ guidwire operation

    PERIPHERAL CLINICAL STUDY

    PROTOCOL
    Design - Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
    Title of the study - A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ Guidewire for crossing chronic total occlusion in Peripheral arteries.
    Study Device -  CiTop™ Guidewire
    Study Sites - Rabin Medical Centre, Israel
                         Clinical Hospital Centre, Clinic for Radiology, Zagreb, Croatia
                         University Hospital, Split, Croatia
    Number of patients - 50 patients
    Indication - Chronic Total occlusion of Peripheral Arteries (more than three months old)   

    RESULTS (April 2008)

  • Attempts were made to cross 24 occlusions in 19 patients

  • The CiTop™ guidewire has crossed successfully 92.3% of the occlusions that were allocated to the CiTop™ guidewire and 80% of the occlusions that the standard guidewire has failed to cross after a 10 minute attempt.

  • The average crossing time of the CiTop™ Guidewire was 3.5 ±3.1 minutes.





                   Figure 3 - Before and After CiTop™ Guidewire operation 

    CORONARY FIRST-IN-MAN STUDY

    PROTOCOL
    Title of the study - A feasibility study to evaluate the safety and efficacy of the CiTop™ Expander™ Guidewire for crossing chronic total occlusion in Coronary arteries.
    Project Number - 4C-b India No. OVC-C01
    Study Device - CiTop™ Expander ™ Guidewire
    Study Objective - To evaluate the safety and efficacy of the CiTop™ Expander ™ guidewire for crossing chronic total occlusion in coronary arteries
    Number of patients - 10 patients with chronic totally occluded coronary artery at one (1) investigational site
    Indication - Chronic Total occlusion of Coronary Arteries (more than one month)
    Initiation of the study - August 2007
    Study Termination Date - February 2008
    Patients Follow Up - One week and 30 days post procedure     

    RESULTS

  • The CiTop™ Expander™ guidewire has successfully crossed 7/10 occlusions

  • No device-related complications/adverse events reported in-lab or during 30 days follow-up period

  • The average procedure time from insertion until crossing was 14.1±10.2 minutes.



                       Figure 4 - 12 months CTO treated by CiTop™ Guidewire

    CORONARY MULTICENTER STUDY

    A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ Guidewire for crossing chronic total occlusion in Coronary arteries is expected to commence during June 2008.