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

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

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

Study Overview

• Status: Terminated
• Conditions: Coronary Chronic Total Occlusion
• Intervention / Treatment: Device: CiTop™ ExPander™ Guidewire

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Wuppertal, Germany, D-42117
    • Helios Klinikum Wuppertal
• South Africa
  • Boksburg, South Africa
    • Sunward Park Hospital
  • Sunninghill, South Africa, 2157
    • Sunninghill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Fluoroscopy time	during procedure
Successful stenting	During procedure, Day1, Day7 and Day30 post procedure
Wire crossing duration	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

Collaborators and Investigators

• Sponsor: Ovalum

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: August 10, 2008
• First Submitted That Met QC Criteria: August 10, 2008
• First Posted (ESTIMATE): August 12, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 9, 2013
• Last Update Submitted That Met QC Criteria: July 6, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Revascularization; Chronic Total Occlusion; CTO
• Other Study ID Numbers: OVC-003-00