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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Ovalum.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ovalum
ClinicalTrials.gov Identifier:
NCT00482742
First received: June 3, 2007
Last updated: January 2, 2008
Last verified: January 2008
History of Changes
  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:

Estimated Enrollment: 50
Study Start Date: October 2006
Estimated Study Completion Date: June 2008
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482742

Locations
Croatia
University Hospital Split Recruiting
Split, Croatia, 21000
Contact: Boris Ljahnicky, MD         daits@zg.t-com.hr    
Principal Investigator: Josip Mascovic, PhD MD            
Clinical Hospital Centre Zagreb Recruiting
Zagreb, Croatia, 10000
Contact: Boris Ljahnicky, MD     +385912337915     dr.ljahnicky@zg.t-com.hr    
Principal Investigator: Cacic Zlatko, MD            
Israel
Rabin Campus, Belinson Hospital Recruiting
Petah-Tikva, Israel, 49100
Contact: Mazal     +97239376391     alexanderb@clalit.org.il    
Principal Investigator: Alexander Belenky, MD            
Sponsors and Collaborators
Ovalum
Investigators
Principal Investigator: Alexander Belenky, MD Research Fund, Belinson Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00482742     History of Changes
Other Study ID Numbers: OVC-P01-00.CTIL
Study First Received: June 3, 2007
Last Updated: January 2, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Ovalum:
Chronic Total Occlusion

ClinicalTrials.gov processed this record on May 19, 2013