Comparing two techniques for harvesting the left internal thoracic artery in heart surgery

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

This study is testing whether two different ways of taking the left internal thoracic artery for heart surgery can lead to better recovery and survival for people having coronary artery bypass surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1350 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Medical University Innsbruck (Academic / other)
• Drugs / interventions: radiation
• Locations: 8 sites (Graz and 7 other locations)
• Trial ID: NCT05931783 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of two different techniques for harvesting the left internal thoracic artery (LITA) on graft patency rates and patient survival in individuals undergoing coronary artery bypass grafting (CABG). The study is a prospective, randomized, multi-centre trial that aims to determine whether the skeletonized or pedicled harvesting technique yields better clinical outcomes. By comparing these techniques, the trial seeks to provide evidence that could influence surgical practices and improve patient care in coronary artery disease. Participants will be carefully selected based on specific inclusion and exclusion criteria to ensure the validity of the results.

Who should consider this trial

Good fit: Ideal candidates for this study are primary isolated CABG patients with multi-vessel disease.

Not a fit: Patients over 80 years old or those requiring CABG without the use of LITA will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved graft patency rates and better survival outcomes for patients undergoing CABG.

How similar studies have performed: Other studies have explored similar harvesting techniques, but this trial aims to provide more definitive evidence on their comparative effectiveness.

Eligibility criteria

Inclusion criteria:

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).

Exclusion criteria:

* 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 this trial is running

Graz and 7 other locations

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

Study contacts

• Principal investigator: Hannes Abfalterer, Dr. med. univ. — Medical University Innsbruck
• Study coordinator: Hannes Abfalterer, Dr. med. univ.

Conditions Coronary Artery Disease; CABG; LITA; graft patency; skeletonized vs. pedicled