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

NCT00482742 | Terminated DMC

• 1 other identifier: OVC-P01-00.CTIL
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 3

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

Keywords

Chronic Total Occlusion

Study Arms (2)

Lifestyle counseling

OTHER

Device: CiTop(TM) Guidewire

Metformin

OTHER

Device: CiTop(TM) Guidewire

Interventions

CiTop(TM) Guidewire DEVICE

Lifestyle counseling; Metformin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ovalum: lead

Study Sites (3)

University Hospital Split

Split, 21000, Croatia

Location

Clinical Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Rabin Campus, Belinson Hospital

Petah Tikva, 49100, Israel

Location

Study Officials

• Alexander Belenky, MD

  Research Fund, Belinson Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: investigator

Study Record Dates

• First Submitted: June 3, 2007
• First Posted: June 5, 2007
• Study Start: October 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

CR (2); IL (1)