Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

NCT05931783 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1350

Last updated 2024-03-15

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Medical University Innsbruck

    lead OTHER

Principal Investigators

  • Hannes Abfalterer, Dr. med. univ. · Medical University Innsbruck

  • Nikolaos Bonaros, Univ. Prof. Dr. · Medical University Innsbruck

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-12
Primary Completion
2028-10-01
Completion
2031-10-01

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05931783 on ClinicalTrials.gov