Status:
TERMINATED
Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
Lead Sponsor:
Ovalum
Conditions:
Coronary Chronic Total Occlusion
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™ Guidewire for crossing chronic total occlusion in Coronary arteries.
Eligibility Criteria
Inclusion
- Informed consent obtained prior to any trial activities.
- Patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see exclusion criteria).
- Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.
Exclusion
- Patient unable to give informed consent.
- Current participation in another study with any investigational drug or device.
- Factors making follow-up and/or repeat angiography difficult or unlikely.
- Contra-indication to emergency artery by pass surgery.
- Lack of surgical backup.
- Contra-indication to treatment with Aspirin, or Clopidogrel and/or Heparin.
- Lesion \> 40mm in length (both calcified lesion and adjacent thrombus).
- Treated vessel referenced diameter less than 2.5 mm.
- Visualization of the distal lumen less than the Rentrop Classification Grade 2 collateralization.
- Non-visible entry point of target lesion.
- Totally occluded bypass graft as target vessel.
- Acute MI less than 1 week before procedure.
- Patient has significant LV dysfunction, 35% LVEF or less.
- Patient with cancer or other sever chronic disease with life expectance of 2 years.
- Patient has chronic renal failure with serum creatinine ≥2.
- Hemoglobin ≤11.
- Patient is known or suspected not to tolerate the contrast agent.
- Morbid Obesity (BMI \> 40).
- Drug abuse or alcoholism.
- Patients under custodial care.
- Pregnant women or women with childbearing potential with a positive pregnancy test at the time of procedure.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00733070
Start Date
August 1 2008
End Date
June 1 2013
Last Update
July 9 2013
Active Locations (3)
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1
HELIOS Klinikum Wuppertal
Wuppertal, Germany, D-42117
2
Sunward Park Hospital
Boksburg, South Africa
3
Sunninghill Hospital
Sunninghill, South Africa, 2157