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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00482742
Other study ID # OVC-P01-00.CTIL
Secondary ID
Status Terminated
Phase N/A
First received June 3, 2007
Last updated July 6, 2013
Start date October 2006
Est. completion date June 2013

Study information

Verified date July 2013
Source Ovalum
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 50
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
CiTop(TM) Guidewire


Locations

Country Name City State
Croatia University Hospital Split Split
Croatia Clinical Hospital Centre Zagreb Zagreb
Israel Rabin Campus, Belinson Hospital Petah-Tikva

Sponsors (1)

Lead Sponsor Collaborator
Ovalum

Countries where clinical trial is conducted

Croatia,  Israel, 

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