Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

Last updated: March 13, 2024
Sponsor: Medical University Innsbruck
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Chest Pain

Atherosclerosis

Treatment

pedicled harvesting technique

skeletonized harvesting technique

Clinical Study ID

NCT05931783
1135/2023
  • Ages 18-80
  • All Genders

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 Criteria

Inclusion

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

Exclusion

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

Study Design

Total Participants: 1350
Treatment Group(s): 2
Primary Treatment: pedicled harvesting technique
Phase:
Study Start date:
March 12, 2024
Estimated Completion Date:
October 01, 2031

Connect with a study center

  • Medical University of Graz

    Graz,
    Austria

    Site Not Available

  • Medical University of Innsbruck

    Innsbruck,
    Austria

    Active - Recruiting

  • Medical University of Vienna

    Vienna,
    Austria

    Site Not Available

  • University of Duisburg-Essen

    Essen,
    Germany

    Site Not Available

  • University of Freiburg

    Freiburg,
    Germany

    Site Not Available

  • University Hospital Gießen

    Gießen,
    Germany

    Site Not Available

  • University of Jena

    Jena,
    Germany

    Site Not Available

  • University Hospital Bern

    Bern,
    Switzerland

    Site Not Available

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