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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ninos Samano M.D., Örebro County Council
ClinicalTrials.gov Identifier:
NCT01686100
First received: September 12, 2012
Last updated: September 18, 2012
Last verified: September 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Örebro County Council:

Primary Outcome Measures:
  • Patency of the grafts [ Time Frame: Mean time of 15 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stenosis in the grafts. [ Time Frame: Mean time of 15 years. ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01686100

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

Publications:

Responsible Party: Ninos Samano M.D., Doctor, Örebro County Council
ClinicalTrials.gov Identifier: NCT01686100     History of Changes
Other Study ID Numbers: 102841
Study First Received: September 12, 2012
Last Updated: September 18, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014