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

July 6, 2013 updated by: Liat Shochat, Ovalum

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • University Hospital Split
      • Zagreb, Croatia, 10000
        • Clinical Hospital Centre Zagreb
  • Israel
      • Petah-Tikva, Israel, 49100
        • Rabin Campus, Belinson Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Lifestyle counseling
Device: CiTop(TM) Guidewire
OTHER: Metformin
Device: CiTop(TM) Guidewire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ovalum

Investigators

  • Principal Investigator: Alexander Belenky, MD, Research Fund, Belinson Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

June 3, 2007

First Submitted That Met QC Criteria

June 4, 2007

First Posted (ESTIMATE)

June 5, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 9, 2013

Last Update Submitted That Met QC Criteria

July 6, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OVC-P01-00.CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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