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

Catheterization, Peripheral Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00482742
• Other study ID #: OVC-P01-00.CTIL
• 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

• Catheterization, Peripheral

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,