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CT-angiographic Follow up of Patients That Underwent Coronary Bypass Surgery Between 1993-1997

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ClinicalTrials.gov Identifier: NCT01686100
Recruitment Status : Completed
First Posted : September 17, 2012
Last Update Posted : September 19, 2012
Sponsor:
Information provided by (Responsible Party):
Ninos Samano M.D., Örebro County Council

Brief Summary:

Coronary artery surgery (CABG) is necessary to improve blood circulation in many patients with coronary artery disease. This is done by using alternative blood vessels (grafts) to bypass the stenosed coronary arteries. In CABG, vein grafts are traditionally used where surrounding tissue is removed, this may damage the vessel and influence its patency.

The "no-touch" technique was developed by Professor Domingos Souza at the Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital. This technique includes taking out the vein with its surrounding tissue and by this way the vessel is less damaged. The first two follow ups have shown that no-touch grafts had better patency than conventionally extracted graft at 18 months and 8.5 years.

This long term follow up is a continuation of the randomized trial started in 1993 where the patency and incidence of stenoses in the no touch and conventional vein grafts has been studied.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: No touch technique Procedure: Conventional technique Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: CT-angiographic Follow Upp of Patients That Underwent Coronary Bypass Surgery Between 1993-1997. A Randomized Longitudinal Trial.
Study Start Date : June 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: No touch vein grafts
The grafts were harvested with there surrounding tissues.
Procedure: No touch technique
The vein graft is harvested with its surronding tissues.
Active Comparator: Conventional vein grafts.
The grafts were stripped from surrounding tissue.
Procedure: Conventional technique
The vein graft is stripped from its surrounding tissues.



Primary Outcome Measures :
  1. Patency of the grafts [ Time Frame: Mean time of 15 years. ]

Secondary Outcome Measures :
  1. Stenosis in the grafts. [ Time Frame: Mean time of 15 years. ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. First time coronary artery bypass grafting with either conventional or no touch vein grafts performed by Dr.Souza between 1993-1997.
  2. Included in the previous follow up studies
  3. Signed and dated consent.

Exclusion Criteria:

  1. Allergy to contrast
  2. Renal failure
  3. Uncontrolled diabetes
  4. Unable to implement the study according to protocol -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686100


Locations
Sweden
Department for Cardiovascular and Thoracic Surgery, Örebro University Hospital
Örebro, Sweden, 70185
Sponsors and Collaborators
Örebro County Council

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ninos Samano M.D., Doctor, Örebro County Council
ClinicalTrials.gov Identifier: NCT01686100     History of Changes
Other Study ID Numbers: 102841
First Posted: September 17, 2012    Key Record Dates
Last Update Posted: September 19, 2012
Last Verified: September 2012

Keywords provided by Ninos Samano M.D., Örebro County Council:
Coronary artery bypass grafting
Saphenous vein grafts

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases