Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT05931783

Run by

Medical University Innsbruck

People needed

1350

Starts

2024-03-12

Expected to finish

2031-10-01

Last updated by the study team

2024-03-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary isolated CABG patients with multi-vessel disease (defined as ≥70 % stenosis of the left anterior descending artery (LAD) and ≥50% stenosis of circumflex and right coronary territory, with or without a ≥50% stenosis of the left main artery).

You may not qualify if…

• Age > 80 years
• Planned CABG without LITA use
• Preoperative mediastinal radiation therapy
• Emergency operation
• Minimal invasive coronary artery bypass surgery
• Any concomitant cardiac or non-cardiac procedures
• Previous cardiac surgery
• Known contrast agent allergy
• Severe stenosis of the left subclavian artery/ left-sided subclavian steal syndrome
• Chronic kidney disease (GFR <60ml/min/1.73m²)
• Life expectancy of less than 5 years
• Pregnancy
• Hyperthyroidism
• Iodine allergy
• Intraoperative exclusion criteria:
• Y/T graft off the LITA graft
• LITA sequential grafting
• LITA target vessel other than LAD

Where it is running

• Medical University of Innsbruck — Innsbruck, Austria (enrolling)
• Medical University of Vienna — Vienna, Austria
• University of Duisburg-Essen — Essen, Germany
• University of Freiburg — Freiburg im Breisgau, Germany
• University Hospital Gießen — Giessen, Germany
• University of Jena — Jena, Germany
• Medical University of Graz — Graz, Austria
• University Hospital Bern — Bern, Switzerland

Full record on ClinicalTrials.gov

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