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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Catheterization, Peripheral

Intervention / Treatment
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* Device: CiTop(TM) Guidewire


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lifestyle counseling<br> | Device: CiTop(TM) Guidewire<br> <br> |
| Other: Metformin<br> | Device: CiTop(TM) Guidewire<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Total Occlusion