Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Procedure: skeletonized harvesting technique; Procedure: pedicled harvesting technique

• Registration Number: NCT05931783
• Lead Sponsor: Medical University Innsbruck

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-05
• Study Start: 2024-03-12
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2028-10-01
• Study Completion: 2031-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
skeletonized harvesting technique	skeletonized harvesting technique	In skeletonized harvesting technique, only the left internal artery itself is harvested.
pedicled harvesting technique	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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
composite outcome of all-cause death, myocardial infarction and repeated revascularization	1 year, 2 years and 5 years after surgery	The composite outcome of all-cause death, myocardial infarction and repeated revascularization will be compared with Kaplan-Meier graphs together with log-rank testing.

Trial Locations

Locations (8)

Medical University of Innsbruck; 🇦🇹 Innsbruck, Austria

Medical University of Vienna; 🇦🇹 Vienna, Austria

University of Duisburg-Essen; 🇩🇪 Essen, Germany

University of Freiburg; 🇩🇪 Freiburg, Germany

University Hospital Gießen; 🇩🇪 Gießen, Germany

University of Jena; 🇩🇪 Jena, Germany

Medical University of Graz; 🇦🇹 Graz, Austria

University Hospital Bern; 🇨🇭 Bern, Switzerland