Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

NCT05931783 · tracked via the Priya Life Science Austria tracker

Sponsor

Medical University Innsbruck

Phase

Not applicable

Started

2024-03-12

Last updated

2024-03-15

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

skeletonized harvesting techniquepedicled harvesting technique

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

Death or LITA graft occlusion in cCTA or invasive angiography within 2 years (+/- 3 months) after surgery. — 2 years (+/- 3 months) after surgery
The primary endpoint will be compared between the two treatment groups using Kaplan-Meier graphs and a center stratified two sample log-rank test. In addition, Cox proportional hazards regression analysis adjusting for clinically relevant confounders will be performed. Hazard ratios and their 95% confidence intervals will be estimated. LITA graft occlusion is defined as the absence of contrast detection in the lumen of the graft indicating a 100% occlusion of LITA graft.

Trial sites (8)

Facility	City	Region	Status
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05931783 on ClinicalTrials.gov ↗ ← All trials in Austria