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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02339857
Other study ID # 102881
Secondary ID
Status Completed
Phase N/A
First received January 12, 2015
Last updated January 15, 2015
Start date November 2011

Study information

Verified date January 2015
Source Örebro County Council
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study was to investigate whether the no-touch saphenous vein grafts that were used in coronary artery bypass surgery between 2003-2008 had a patency rate comparable to the left internal thoracic artery when the vein grafts were anatomised to the left anterior descending artery.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

1. Coronary artery bypass grafting performed at the Department of Cardiothoracic Surgery, Örebro Universtiy Hospital between 2003-2008.

2. Saphenous vein graft harvesting using the no-touch technique.

3. The saphenous vein anastomised to the left anterior descending artery.

4. Informed consent

Exclusion Criteria:

1. Allergy to contrast media.

2. Impaired renal function.

3. Inability to conduct the study according to protocol.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
No-touch harvesting technique
The saphenous vein is harvested with a pedicle of surrounding tissue.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Örebro County Council

Outcome

Type Measure Description Time frame Safety issue
Primary Total patency of the no-touch vein grafts. Mean time 8 years. No
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