Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
NCT ID: NCT00618020
Last Updated: 2008-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2007-08-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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CiTop(tm) Guidewire
CiTop(tm)6 Guidewire
Eligibility Criteria
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Inclusion Criteria
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.
21 Years
80 Years
ALL
No
Sponsors
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Ovalum
INDUSTRY
Responsible Party
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Ovalum Ltd.
Principal Investigators
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Keyur Parikh, MD
Role: PRINCIPAL_INVESTIGATOR
Chairman,CardioVascular Services,SAL Hospital
Locations
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S.A.L Hospital
Ahmedabad, Gujarat, India
Countries
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Other Identifiers
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4C-b No. OVC-C01
Identifier Type: -
Identifier Source: org_study_id