Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
Primary Purpose
Coronary Occlusion
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
CiTop(tm) Guidewire
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Occlusion focused on measuring CTO, Chronic Total Occlusion, Revascularization
Eligibility Criteria
Inclusion Criteria:
- Informed consent obtained prior to any trial activities.
- Patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see exclusion criteria).
- Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.
Exclusion Criteria:
- Patient unable to give informed consent.
- Current participation in another study with any investigational drug or device.
- Factors making follow-up and/or repeat angiography difficult or unlikely.
- Contra-indication to emergency artery by pass surgery.
- Lack of surgical backup.
- Contra-indication to treatment with Aspirin, or Clopidogrel and/or Heparin.
- Lesion > 40mm in length (both calcified lesion and adjacent thrombus).
- Treated vessel referenced diameter less than 2.5 mm.
- Visualization of the distal lumen less than the Rentrop Classification Grade 2 collateralization.
- Non-visible entry point of target lesion.
- Totally occluded bypass graft as target vessel.
- Acute MI less than 1 week before procedure.
- Patient has significant LV dysfunction, 35% LVEF or less.
- Patient with cancer or other sever chronic disease with life expectance of 2 years.
- Patient has chronic renal failure with serum creatinine ≥2.
- Hemoglobin ≤11.
- Patient is known or suspected not to tolerate the contrast agent.
- Morbid Obesity (BMI > 40).
- Drug abuse or alcoholism.
- Patients under custodial care.
- Pregnant women or women with childbearing potential with a positive pregnancy test at the time of procedure.
Sites / Locations
- S.A.L Hospital
Outcomes
Primary Outcome Measures
Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications.
Secondary Outcome Measures
Successful stenting
Wire crossing duration
Fluoroscopy time
Amount of contrast
Maneuverability of the CiTop™ up to the occlusion
No mechanical damage to the device during
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00618020
Brief Title
Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
Official Title
A Feasibility Study to Evaluate the Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusion in Coronary Arteries
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ovalum
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Occlusion
Keywords
CTO, Chronic Total Occlusion, Revascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CiTop(tm) Guidewire
Intervention Description
CiTop(tm)6 Guidewire
Primary Outcome Measure Information:
Title
Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications.
Time Frame
during procedure, 1day, 1week and 30 days post procedure
Secondary Outcome Measure Information:
Title
Successful stenting
Time Frame
During procedure, Day1, Day7 and Day30 post procedure
Title
Wire crossing duration
Time Frame
during procedure
Title
Fluoroscopy time
Time Frame
during procedure
Title
Amount of contrast
Time Frame
during procedure
Title
Maneuverability of the CiTop™ up to the occlusion
Time Frame
during procedure
Title
No mechanical damage to the device during
Time Frame
during procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent obtained prior to any trial activities.
Patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see exclusion criteria).
Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.
Exclusion Criteria:
Patient unable to give informed consent.
Current participation in another study with any investigational drug or device.
Factors making follow-up and/or repeat angiography difficult or unlikely.
Contra-indication to emergency artery by pass surgery.
Lack of surgical backup.
Contra-indication to treatment with Aspirin, or Clopidogrel and/or Heparin.
Lesion > 40mm in length (both calcified lesion and adjacent thrombus).
Treated vessel referenced diameter less than 2.5 mm.
Visualization of the distal lumen less than the Rentrop Classification Grade 2 collateralization.
Non-visible entry point of target lesion.
Totally occluded bypass graft as target vessel.
Acute MI less than 1 week before procedure.
Patient has significant LV dysfunction, 35% LVEF or less.
Patient with cancer or other sever chronic disease with life expectance of 2 years.
Patient has chronic renal failure with serum creatinine ≥2.
Hemoglobin ≤11.
Patient is known or suspected not to tolerate the contrast agent.
Morbid Obesity (BMI > 40).
Drug abuse or alcoholism.
Patients under custodial care.
Pregnant women or women with childbearing potential with a positive pregnancy test at the time of procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keyur Parikh, MD
Organizational Affiliation
Chairman,CardioVascular Services,SAL Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
S.A.L Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380054
Country
India
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
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