Catheterization, Peripheral
Conditions
Keywords
Chronic Total Occlusion
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.
Interventions
DEVICECiTop(TM) Guidewire
Sponsors
Ovalum
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
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).
Countries
Croatia, Israel
Outcome results
None listed