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Safety & Performance Randomized Study of the CiTop™ Guidewire for Peripheral CTO

Sponsor
Ovalum (Industry)
Overall Status
Terminated
CT.gov ID
NCT00482742
Collaborator
(none)
50
Enrollment
3
Locations
2
Arms
80
Duration (Months)
16.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objectives of the study are:

To evaluate the performance and safety of the CiTop guidewire, while attempting to cross thru total occlusions of various dimensions and morphology.

To compare the safety and efficacy of the CiTop guidewire with standard guidewires in terms of impact on the treated artery. Following operation of the CiTop device, angiography demonstrated successful crossing of the occlusion with no visible evidence of arterial wall injury, dissection, or distal embolization.

To assess ease of operation and the level of integration of the CiTop with standard interventional angiography procedure: Balloon angioplasty, placement of stent.

Condition or Disease Intervention/Treatment Phase
  • Device: CiTop(TM) Guidewire
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Feasibility, Multi Center Multinational Randomized Open Label Study, to Evaluate the Safety and Performance of the CiTop™ Guidewire for Crossing Total Occlusion in Peripheral Arteries.
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: Lifestyle counseling

Device: CiTop(TM) Guidewire
Other: Metformin

Device: CiTop(TM) Guidewire

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Clinical Inclusion Criteria:

    • Patient with symptomatic peripheral vascular disease, intermittent claudication less than 30 meters, rest pain or tissue ischemia.(Fontain grade 3-4)

    • Critical limb Ischemia

    • The patient has Chronic Total Occlusion in limb arteries, aged at least 3 months.

    • Patient has chronic total occlusion (CTO) that is:

    • Documented angiographically, by the investigator or co-investigator.

    • CTO was defined as an obstruction of a main peripheral artery with no luminal continuity and with TIMI (Thrombolysis In Myocardial Infraction) flow grade of 0 or 1.

    • CTO location suitable for endovascular treatment (not in parallel location with the hip or knee joints).

    • Lesion ≤ 8cm in length

    • Lesion located in a segment with diameter more than 1.5 mm

    • Adequate compliance with follow-up and/or repeat angiography

    • No Contra-indication to treatment with aspirin or ticlopidine or clopidogrel and/or Heparin

    • Visible entry point of target lesion

    • NO cancer or other life threatening diseases or conditions

    • NO diagnosis or suspected renal failure (2 x ULN of creatinine)

    • Not suspected intolerance of the contrast agent

    • NO Drug abuse or alcoholism

    • Patients is NOT under custodial care

    • Women with childbearing potential are NOT pregnant (positive pregnancy test at the time of procedure).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Split Split Croatia 21000
    2 Clinical Hospital Centre Zagreb Zagreb Croatia 10000
    3 Rabin Campus, Belinson Hospital Petah-Tikva Israel 49100

    Sponsors and Collaborators

    • Ovalum

    Investigators

    • Principal Investigator: Alexander Belenky, MD, Research Fund, Belinson Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Liat Shochat, investigator, Ovalum
    ClinicalTrials.gov Identifier:
    NCT00482742
    Other Study ID Numbers:
    • OVC-P01-00.CTIL
    First Posted:
    Jun 5, 2007
    Last Update Posted:
    Jul 9, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Liat Shochat, investigator, Ovalum
    Chronic Total Occlusion

    Study Results

    No Results Posted as of Jul 9, 2013