Clinical trial NCT00733070: Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
Official title: A Multicenter Multinational Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Chronic Total Occlusion
Keywords: CTO
Chronic Total Occlusion
Revascularization
Lead sponsor: Ovalum
Sponsor class: INDUSTRY
First posted: 2008-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications
timeFrame: during procedure, 1day, 1week and 30 days post procedure
Secondary outcomes:
measure: Successful stenting
timeFrame: During procedure, Day1, Day7 and Day30 post procedure
measure: Wire crossing duration
timeFrame: during procedure
measure: Fluoroscopy time
timeFrame: during procedure
measure: Amount of contrast
timeFrame: during procedure
measure: Maneuverability of the CiTop™ up to the occlusion
timeFrame: during procedure
measure: No mechanical damage to the device during
timeFrame: during procedure
Other outcomes:
Locations:
city: Wuppertal
country: Germany
facility: HELIOS Klinikum Wuppertal
city: Boksburg
country: South Africa
facility: Sunward Park Hospital
city: Sunninghill
country: South Africa
facility: Sunninghill Hospital
Study officials:
References: