NCT05931783 Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery
| NCT ID | NCT05931783 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University Innsbruck |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,350 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,350 participants in total. It began in 2024-03-12 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Hannes Abfalterer, Dr. med. univ.
PRINCIPAL INVESTIGATOR
Medical University Innsbruck
Frequently Asked Questions
Who can join the NCT05931783 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05931783 currently recruiting?
Yes, NCT05931783 is actively recruiting participants. Contact the research team at hannes.abfalterer@i-med.ac.at for enrollment information.
Where is the NCT05931783 trial being conducted?
This trial is being conducted at Graz, Austria, Innsbruck, Austria, Vienna, Austria, Essen, Germany and 4 additional locations.
Who is sponsoring the NCT05931783 clinical trial?
NCT05931783 is sponsored by Medical University Innsbruck. The principal investigator is Hannes Abfalterer, Dr. med. univ. at Medical University Innsbruck. The trial plans to enroll 1,350 participants.