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

Not Applicable

Completed

• Conditions: Coronary Occlusion

• Registration Number: NCT00618020
• Lead Sponsor: Ovalum

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-01-28
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-18
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-17
• Last Update Posted: 2008-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications.	during procedure, 1day, 1week and 30 days post procedure

Secondary Outcome Measures

Name	Time	Method
Maneuverability of the CiTop™ up to the occlusion	during procedure
No mechanical damage to the device during	during procedure
Successful stenting	During procedure, Day1, Day7 and Day30 post procedure
Wire crossing duration	during procedure
Fluoroscopy time	during procedure
Amount of contrast	during procedure

Trial Locations

Locations (1)

S.A.L Hospital; 🇮🇳 Ahmedabad, Gujarat, India