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

Coronary Occlusion Clinical Trial

Official title:

A Feasibility Study to Evaluate the Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusion in Coronary Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618020
• Other study ID #: 4C-b No. OVC-C01
• Status: Completed
• Phase: N/A
• First received: January 28, 2008
• Last updated: July 17, 2008
• Start date: August 2007
• Est. completion date: February 2008

Study information

• Verified date: July 2008
• Source: Ovalum
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The CiTop™ guidewire Coronary study is a feasibility open label study, to evaluate the safety and efficacy of the CiTop™ Guidewire for crossing chronic total occlusion in Coronary arteries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• 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, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Occlusion

Intervention

Device:
• CiTop(tm) Guidewire
CiTop(tm)6 Guidewire

Locations

Country	Name	City	State
India	S.A.L Hospital	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Ovalum

Country where clinical trial is conducted

India, 

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