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

NCT ID: NCT00482742

Last Updated: 2013-07-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2013-06-30

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.

Conditions

Catheterization, Peripheral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle counseling

Group Type: OTHER

CiTop(TM) Guidewire

Intervention Type: DEVICE

Metformin

Group Type: OTHER

CiTop(TM) Guidewire

Intervention Type: DEVICE

Interventions

CiTop(TM) Guidewire

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ovalum

INDUSTRY

Sponsor Role: lead

Responsible Party

Liat Shochat

investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Belenky, MD

Role: PRINCIPAL_INVESTIGATOR

Research Fund, Belinson Hospital

Locations

University Hospital Split

Split, , Croatia

Clinical Hospital Centre Zagreb

Zagreb, , Croatia

Rabin Campus, Belinson Hospital

Petah Tikva, , Israel

Countries

Croatia; Israel

Other Identifiers

OVC-P01-00.CTIL

Identifier Type: -

Identifier Source: org_study_id