- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01310725
Evaluation of Graft Material in Coronary Artery Bypass Grafting (CABG)
Mid-term Patency of Radial Artery and No Touch Saphenous Vein as Grafts in CABG; A Randomised Controlled Trial.
The aim of the study is to evaluate the patency in different kinds of vessels used as graft material in coronary artery bypass grafting.
The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the same, or better, patency compared to radial grafts and that skeletonisation of the left internal mammary artery does not effect the patency for this graft.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients undergoing coronary artery bypass grafting are included in the study.
Each patient receive a radial artery graft and a vein graft harvested with a pedicle of surrounding tissue to the right and left side of the heart respectively. The left internal mammary artery is used for the left anterior descending artery in a skeletonised or non-skeletonised fashion.
The evaluation is made with angiography up to 5 years after surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Orebro, Sweden, 701 85
- Dept of Cardiothoracic Surgery, Orebro University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Isolated coronary artery disease embracing all three main branches of the coronary artery tree.
Exclusion Criteria:
- Kidney insufficiency (Creatinine > 120 µmol/L)
- War-farin anticoagulation therapy
- Ejection fraction < 40%
- Repeat operation
- Other concurrent sur-gery
- Signs of reduced circulation in non-dominant hand
- Other severe illness, or if the patient declines to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional grafts defined as opened or closed.
Time Frame: Up to 5 years after surgery.
|
Up to 5 years after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Degree of stenosis in implanted grafts.
Time Frame: Up to 5 years after surgery.
|
Up to 5 years after surgery.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Lars Norgren, MD, PhD, Prof., Örebro University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- mdr001
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 Angina Pectoris
-
University Hospital, AntwerpRecruitingAngina Pectoris, Variant | Angina Pectoris; Spasm-Induced | Angina Pectoris With Normal Coronary ArteriogramBelgium
-
Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and DevelopmentNot yet recruitingAngina Pectoris; Angiospastic
-
Region Örebro CountyBiosensors InternationalWithdrawnStable Angina Pectoris | Unstable Angina Pectoris | Myocardial Infacrtion
-
The People's Hospital of Liaoning ProvinceUnknownStable Angina Pectoris | Unstable Angina PectorisChina
-
Society for Advancement of Coronary Intervention...UnknownStable Angina Pectoris | Unstable Angina PectorisJapan
-
Zhejiang Chinese Medical UniversityThe Third Affiliated hospital of Zhejiang Chinese Medical University; The First...UnknownChronic Stable Angina PectorisChina
-
Zhejiang Chinese Medical UniversityThe Third Affiliated hospital of Zhejiang Chinese Medical University; The First...UnknownChronic Stable Angina PectorisChina
-
Atlantic Health SystemMallinckrodtTerminatedStable Angina Pectoris | Unstable Angina Pectoris | Silent IschemiaUnited States
-
Zhejiang Chinese Medical UniversityThe First Affiliated Hospital of Zhejiang Chinese Medical UniversityUnknownChronic Stable Angina PectorisChina
-
Zhejiang Chinese Medical UniversityThe Third Affiliated hospital of Zhejiang Chinese Medical University; The First...Unknown
Clinical Trials on Coronary artery bypass grafting
-
University of OuluKarolinska Institutet; Universita di Verona; University of Campania "Luigi Vanvitelli... and other collaboratorsRecruitingMyocardial Infarction | Coronary Artery Disease | Angina PectorisFinland
-
University of WuerzburgDeutsche Stiftung für HerzforschungUnknownStroke | Coronary Heart Disease | Cerebral InfarctionGermany
-
University Medical Center GroningenUnknownCoronary Artery Bypass | Cognitive DysfunctionNetherlands
-
Cliniques universitaires Saint-Luc- Université...Completed
-
Far Eastern Memorial HospitalCompletedCoronary Artery Disease
-
Tomsk National Research Medical Center of the Russian...Russian Science FoundationRecruitingCoronary Artery Disease | Heart FailureRussian Federation
-
Austin HealthActive, not recruitingCoronary Artery Disease | AtherosclerosisAustralia
-
Armed Forces Institute of Cardiology, PakistanCompleted
-
German Off Pump Coronary Artery Bypass in Elderly...Institut für Klinisch-Kardiovaskuläre Forschung GmbH; Deutsche Gesellschaft...Completed
-
Centro Cardiologico MonzinoUnknownAtherosclerosis | Myocardial RevascularizationItaly