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

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-06-30

Brief Summary

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A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™ Guidewire for crossing chronic total occlusion in Coronary arteries.

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Detailed Description

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Conditions

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Coronary Chronic Total Occlusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CiTop™ ExPander™ Guidewire

Chronic Total Occlusion guidewire

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Informed consent obtained prior to any trial activities.

Exclusion Criteria

3. Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No