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

This study has been terminated.
(product development was cancelled)
Sponsor:
Information provided by (Responsible Party):
Liat Shochat, Ovalum
ClinicalTrials.gov Identifier:
NCT00482742
First received: June 3, 2007
Last updated: July 6, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Catheterization, Peripheral
Device: CiTop(TM) Guidewire

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by Ovalum:

Enrollment: 50
Study Start Date: October 2006
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lifestyle counseling Device: CiTop(TM) Guidewire
Metformin Device: CiTop(TM) Guidewire

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482742

Locations
Croatia
University Hospital Split
Split, Croatia, 21000
Clinical Hospital Centre Zagreb
Zagreb, Croatia, 10000
Israel
Rabin Campus, Belinson Hospital
Petah-Tikva, Israel, 49100
Sponsors and Collaborators
Ovalum
Investigators
Principal Investigator: Alexander Belenky, MD Research Fund, Belinson Hospital
  More Information

No publications provided

Responsible Party: Liat Shochat, investigator, Ovalum
ClinicalTrials.gov Identifier: NCT00482742     History of Changes
Other Study ID Numbers: OVC-P01-00.CTIL
Study First Received: June 3, 2007
Last Updated: July 6, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Ovalum:
Chronic Total Occlusion

ClinicalTrials.gov processed this record on July 23, 2014