Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery
NCT05931783 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1350
Last updated 2024-03-15
Summary
Internal thoracic arteries can be harvested in skeletonized or pedicled technique. Latest research has posed a potential adverse effect of skeletonizing the internal thoracic arteries on graft patency rates and clinical outcome. Prospective, randomized, multi-centre trials are necessary to investigate the impact of harvesting technique of left internal thoracic artery (LITA) on graft patency rates and clinical outcome after coronary artery bypass grafting.
The HARVITA trial compares skeletonized and pedicled harvesting technique of LITA regarding graft patency rates and patient survival.
Conditions
Interventions
- PROCEDURE
-
skeletonized harvesting technique
In patients who are randomized to this treatment arm, the left internal thoracic artery will be harvested in skeletonized technique. Thereby, only the artery itself is harvested.
- PROCEDURE
-
pedicled harvesting technique
In patients who are randomized to this treatment arm, the left internal thoracic artery will be harvested in pedicled technique. Thereby, the artery will be harvested together with the accompanying veins, the endothoracic fascia and fatty tissue in order to create an 1-2 cm broad pedicle.
Sponsors & Collaborators
-
Medical University Innsbruck
lead OTHER
Principal Investigators
-
Hannes Abfalterer, Dr. med. univ. · Medical University Innsbruck
-
Nikolaos Bonaros, Univ. Prof. Dr. · Medical University Innsbruck
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-12
- Primary Completion
- 2028-10-01
- Completion
- 2031-10-01
Countries
- Austria
- Germany
- Switzerland
Study Locations
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