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

June 3, 2007
July 6, 2013
October 2006
June 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00482742 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety & Performance Randomized Study of the CiTop™ Guidewire for Peripheral CTO
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Catheterization, Peripheral
Device: CiTop(TM) Guidewire
  • Lifestyle counseling
    Intervention: Device: CiTop(TM) Guidewire
  • Metformin
    Intervention: Device: CiTop(TM) Guidewire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
June 2013
June 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Croatia,   Israel
 
NCT00482742
OVC-P01-00.CTIL
Yes
Liat Shochat, Ovalum
Ovalum
Not Provided
Principal Investigator: Alexander Belenky, MD Research Fund, Belinson Hospital
Ovalum
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP