Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
A Feasibility Study to Evaluate the Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusion in Coronary Arteries
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 18, 2008
CompletedJuly 18, 2008
July 1, 2008
6 months
January 28, 2008
July 17, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Successful stenting
During procedure, Day1, Day7 and Day30 post procedure
Wire crossing duration
during procedure
Fluoroscopy time
during procedure
Amount of contrast
during procedure
Maneuverability of the CiTop™ up to the occlusion
during procedure
- +1 more secondary outcomes
Interventions
CiTop(tm)6 Guidewire
Eligibility Criteria
You may qualify if:
- Informed consent obtained prior to any trial activities.
You may not qualify if:
- Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ovalumlead
Study Sites (1)
S.A.L Hospital
Ahmedabad, Gujarat, 380054, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keyur Parikh, MD
Chairman,CardioVascular Services,SAL Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 28, 2008
First Posted
February 18, 2008
Study Start
August 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
July 18, 2008
Record last verified: 2008-07