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
  Purpose

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.


Condition Intervention
Coronary Occlusion
Device: CiTop(tm) Guidewire

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate the Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusion in Coronary Arteries

Further study details as provided by Ovalum:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: August 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CiTop(tm) Guidewire
    CiTop(tm)6 Guidewire
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618020

Locations
India
S.A.L Hospital
Ahmedabad, Gujarat, India, 380054
Sponsors and Collaborators
Ovalum
Investigators
Principal Investigator: Keyur Parikh, MD Chairman,CardioVascular Services,SAL Hospital
  More Information

No publications provided

Responsible Party: Clinical Affairs, Ovalum Ltd.
ClinicalTrials.gov Identifier: NCT00618020     History of Changes
Other Study ID Numbers: 4C-b No. OVC-C01
Study First Received: January 28, 2008
Last Updated: July 17, 2008
Health Authority: India: Institutional Review Board

Keywords provided by Ovalum:
CTO
Chronic Total Occlusion
Revascularization

Additional relevant MeSH terms:
Coronary Occlusion
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014