NCT05931783

Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

Randomized Comparison of HARVesting the Left Internal Thoracic Artery in a Skeletonized Versus Pedicled Technique: the HARVITA Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,350 (estimated)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Coronary Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-12
• Primary completion: 2028-10-01
• Completion: 2031-10-01
• First posted: 2023-07-05
• Last updated: 2024-03-15

Locations

8 sites across 3 countries: Austria, Germany, Switzerland