Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2031-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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skeletonized harvesting technique

In skeletonized harvesting technique, only the left internal artery itself is harvested.

Group Type ACTIVE_COMPARATOR

skeletonized harvesting technique

Intervention Type PROCEDURE

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 pedicled harvesting technique the left internal thoracic artery, it's accompanying veins and parts of the endothoracic fascia is harvested, creating a 1-2 cm broad pedicle.

Group Type ACTIVE_COMPARATOR

pedicled harvesting technique

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

* Y/T graft off the LITA graft
* LITA sequential grafting
* LITA target vessel other than LAD

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hannes Abfalterer, Dr. med. univ.

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Nikolaos Bonaros, Univ. Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

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