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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01686100
First Posted: September 17, 2012
Last Update Posted: September 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ninos Samano M.D., Örebro County Council
  Purpose

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 Intervention
Coronary Artery Disease Procedure: No touch technique Procedure: Conventional technique

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Ninos Samano M.D., Örebro County Council:

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

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

Enrollment: 52
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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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 -
  Contacts and Locations
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
  More Information

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 Submitted: September 12, 2012
First Posted: September 17, 2012
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