Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries

This study has been completed.
Sponsor:
Information provided by:
Ovalum
ClinicalTrials.gov Identifier:
NCT00618020
First received: January 28, 2008
Last updated: July 17, 2008
Last verified: July 2008

January 28, 2008
July 17, 2008
August 2007
February 2008   (final data collection date for primary outcome measure)
Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications. [ Time Frame: during procedure, 1day, 1week and 30 days post procedure ] [ Designated as safety issue: Yes ]
Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications. [ Time Frame: During procedure, Day1, Day7 and Day30 post procedure ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00618020 on ClinicalTrials.gov Archive Site
  • Successful stenting [ Time Frame: During procedure, Day1, Day7 and Day30 post procedure ] [ Designated as safety issue: Yes ]
  • Wire crossing duration [ Time Frame: during procedure ] [ Designated as safety issue: No ]
  • Fluoroscopy time [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
  • Amount of contrast [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
  • Maneuverability of the CiTop™ up to the occlusion [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
  • No mechanical damage to the device during [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
• Successful stenting • Wire crossing duration • Fluoroscopy time • Amount of contrast • Lack of procedure related death, stroke, AMI • Maneuverability of the CiTop™ up to the occlusion • No mechanical damage to the device during [ Time Frame: During procedure, Day1, Day7 and Day30 post procedure ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
A Feasibility Study to Evaluate the Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusion in Coronary Arteries

The CiTop™ guidewire Coronary study is a feasibility open label study, to evaluate the safety and efficacy of the CiTop™ Guidewire for crossing chronic total occlusion in Coronary arteries.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Occlusion
Device: CiTop(tm) Guidewire
CiTop(tm)6 Guidewire
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Informed consent obtained prior to any trial activities.
  2. Patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see exclusion criteria).
  3. Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.

Exclusion Criteria:

  1. Patient unable to give informed consent.
  2. Current participation in another study with any investigational drug or device.
  3. Factors making follow-up and/or repeat angiography difficult or unlikely.
  4. Contra-indication to emergency artery by pass surgery.
  5. Lack of surgical backup.
  6. Contra-indication to treatment with Aspirin, or Clopidogrel and/or Heparin.
  7. Lesion > 40mm in length (both calcified lesion and adjacent thrombus).
  8. Treated vessel referenced diameter less than 2.5 mm.
  9. Visualization of the distal lumen less than the Rentrop Classification Grade 2 collateralization.
  10. Non-visible entry point of target lesion.
  11. Totally occluded bypass graft as target vessel.
  12. Acute MI less than 1 week before procedure.
  13. Patient has significant LV dysfunction, 35% LVEF or less.
  14. Patient with cancer or other sever chronic disease with life expectance of 2 years.
  15. Patient has chronic renal failure with serum creatinine ≥2.
  16. Hemoglobin ≤11.
  17. Patient is known or suspected not to tolerate the contrast agent.
  18. Morbid Obesity (BMI > 40).
  19. Drug abuse or alcoholism.
  20. Patients under custodial care.
  21. Pregnant women or women with childbearing potential with a positive pregnancy test at the time of procedure.
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00618020
4C-b No. OVC-C01
Yes
Clinical Affairs, Ovalum Ltd.
Ovalum
Not Provided
Principal Investigator: Keyur Parikh, MD Chairman,CardioVascular Services,SAL Hospital
Ovalum
July 2008

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