- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00618020
Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
July 17, 2008 updated by: Ovalum
A Feasibility Study to Evaluate the Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusion in Coronary Arteries
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gujarat
-
Ahmedabad, Gujarat, India, 380054
- S.A.L Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
Time Frame: during procedure, 1day, 1week and 30 days post procedure
|
during procedure, 1day, 1week and 30 days post procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fluoroscopy time
Time Frame: during procedure
|
during procedure
|
Successful stenting
Time Frame: During procedure, Day1, Day7 and Day30 post procedure
|
During procedure, Day1, Day7 and Day30 post procedure
|
Wire crossing duration
Time Frame: during procedure
|
during procedure
|
Amount of contrast
Time Frame: during procedure
|
during procedure
|
Maneuverability of the CiTop™ up to the occlusion
Time Frame: during procedure
|
during procedure
|
No mechanical damage to the device during
Time Frame: during procedure
|
during procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Keyur Parikh, MD, Chairman,CardioVascular Services,SAL Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
January 28, 2008
First Submitted That Met QC Criteria
February 5, 2008
First Posted (Estimate)
February 18, 2008
Study Record Updates
Last Update Posted (Estimate)
July 18, 2008
Last Update Submitted That Met QC Criteria
July 17, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4C-b No. OVC-C01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Occlusion
-
Assiut UniversityUnknownRight Coronary Artery OcclusionEgypt
-
North Texas Veterans Healthcare SystemTerminatedCoronary Stent OcclusionUnited States
-
San Luigi Gonzaga HospitalRecruitingCoronary Disease | STEMI | Coronary Artery Ectasia | Right Coronary Artery Occlusion | Right Coronary Artery StenosisSpain, Italy
-
Hamilton Health Sciences CorporationGlaxoSmithKlineUnknownCoronary Bypass Graft Failure/OcclusionCanada
-
Yonsei UniversityCompletedCoronary Artery OcclusionKorea, Republic of
-
Volgograd State Medical UniversityEnrolling by invitation
-
Universita di VeronaNational University of Ireland, Galway, IrelandRecruiting
-
University Hospital UlmRecruitingChronic Total Occlusion | Chronic Total Occlusion of Coronary ArteryGermany
-
Acibadem UniversityCompleted
-
Medical University of ViennaCompletedChronic Total Coronary Occlusion
Clinical Trials on CiTop(tm) Guidewire
-
OvalumTerminatedCatheterization, PeripheralCroatia, Israel
-
OvalumTerminatedCoronary Chronic Total OcclusionGermany, South Africa
-
Ziekenhuis Oost-LimburgCompletedAnomalies VascularBelgium
-
Chinese University of Hong KongCompletedAbdominal Pain | Post-ERCP Acute PancreatitisChina
-
Lahey ClinicCompleted
-
Chinese Academy of Medical Sciences, Fuwai HospitalUnknownAtrial Septal DefectChina
-
Ajou University School of MedicineCompletedPancreatic Cancer | Bile Duct Cancer | Choledocholithiasis | Ampullary TumorKorea, Republic of
-
Institut universitaire de cardiologie et de pneumologie...Institut de Cardiologie de MontréalCompletedAortic Valve Stenosis | Aortic Valve Disease | Transcatheter Aortic Valve Replacement | Hemodynamic MeasurementCanada
-
Cordis CorporationCompletedCoronary Artery DiseaseGermany
-
Seoul National University HospitalCompleted