NCT00733070TerminatedNot Applicable
A Multicenter Multinational Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
Ovalum5 sites in 2 countries30 target enrollmentStarted: August 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 30
- Locations
- 5
- Primary Endpoint
- Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Exclusion Criteria:
- •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 ≥
- •Hemoglobin ≤
- •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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Successful stenting(During procedure, Day1, Day7 and Day30 post procedure)
- Wire crossing duration(during procedure)
- Fluoroscopy time(during procedure)
- Amount of contrast(during procedure)
- Maneuverability of the CiTop™ up to the occlusion(during procedure)
- No mechanical damage to the device during(during procedure)
Investigators
Study Sites (5)
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