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

Coronary Chronic Total Occlusion Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00733070
• Other study ID #: OVC-003-00
• Status: Terminated
• Phase: N/A
• First received: August 10, 2008
• Last updated: July 6, 2013
• Start date: August 2008
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Ovalum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Chronic Total Occlusion

Intervention

Device:
• CiTop™ ExPander™ Guidewire
Chronic Total Occlusion guidewire

Locations

Country	Name	City	State
Germany	HELIOS Klinikum Wuppertal	Wuppertal
South Africa	Sunward Park Hospital	Boksburg
South Africa	Sunninghill Hospital	Sunninghill

Sponsors (1)

Lead Sponsor	Collaborator
Ovalum

Countries where clinical trial is conducted

Germany,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications		during procedure, 1day, 1week and 30 days post procedure	Yes
Secondary	Successful stenting		During procedure, Day1, Day7 and Day30 post procedure	Yes
Secondary	Wire crossing duration		during procedure	No
Secondary	Fluoroscopy time		during procedure	Yes
Secondary	Amount of contrast		during procedure	Yes
Secondary	Maneuverability of the CiTop™ up to the occlusion		during procedure	Yes
Secondary	No mechanical damage to the device during		during procedure	Yes