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Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery (HARVITA)

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
skeletonized harvesting technique
pedicled harvesting technique
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CABG, LITA, graft patency, skeletonized vs. pedicled

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Graz
  • Medical University of Innsbruck
  • Medical University of Vienna
  • University of Duisburg-Essen
  • University of Freiburg
  • University Hospital Gießen
  • University of Jena
  • University Hospital Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

skeletonized harvesting technique

pedicled harvesting technique

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Death or LITA graft occlusion in cCTA or invasive angiography within 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

composite outcome of all-cause death, myocardial infarction and repeated revascularization
The composite outcome of all-cause death, myocardial infarction and repeated revascularization will be compared with Kaplan-Meier graphs together with log-rank testing.

Full Information

First Posted
June 22, 2023
Last Updated
July 31, 2023
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT05931783
Brief Title
Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery
Acronym
HARVITA
Official Title
Randomized Comparison of HARVesting the Left Internal Thoracic Artery in a Skeletonized Versus Pedicled Technique: the HARVITA Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2028 (Anticipated)
Study Completion Date
October 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CABG, LITA, graft patency, skeletonized vs. pedicled

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
skeletonized harvesting technique
Arm Type
Active Comparator
Arm Description
In skeletonized harvesting technique, only the left internal artery itself is harvested.
Arm Title
pedicled harvesting technique
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
skeletonized harvesting technique
Intervention Description
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
Intervention Name(s)
pedicled harvesting technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Death or LITA graft occlusion in cCTA or invasive angiography within 2 years (+/- 3 months) after surgery.
Description
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.
Time Frame
2 years (+/- 3 months) after surgery
Secondary Outcome Measure Information:
Title
composite outcome of all-cause death, myocardial infarction and repeated revascularization
Description
The composite outcome of all-cause death, myocardial infarction and repeated revascularization will be compared with Kaplan-Meier graphs together with log-rank testing.
Time Frame
1 year, 2 years and 5 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannes Abfalterer, Dr. med. univ.
Phone
004351250482988
Email
hannes.abfalterer@i-med.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannes Abfalterer, Dr. med. univ.
Organizational Affiliation
Medical University Innsbruck
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nikolaos Bonaros, Univ. Prof. Dr.
Organizational Affiliation
Medical University Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Zimpfer, Univ. Prof. Dr.
Facility Name
Medical University of Innsbruck
City
Innsbruck
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannes Abfalterer, Dr. med. univ.
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigrid Sandner, Assoz. Prof. Priv. Doz. Dr.
Facility Name
University of Duisburg-Essen
City
Essen
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Thielmann, Univ. Prof. Dr.
Facility Name
University of Freiburg
City
Freiburg
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Czerny, Univ. Prof. Dr.
Facility Name
University Hospital Gießen
City
Gießen
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Böning, Univ. Prof. Dr.
Facility Name
University of Jena
City
Jena
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torsten Doenst, Univ. Prof. Dr.
Facility Name
University Hospital Bern
City
Bern
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Siepe, Univ. Prof. Dr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
34132753
Citation
Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686. Erratum In: JAMA Cardiol. 2021 Aug 18;:null.
Results Reference
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PubMed Identifier
34586338
Citation
Gaudino M, Audisio K, Rahouma M, Chadow D, Cancelli G, Soletti GJ, Gray A, Lees B, Gerry S, Benedetto U, Flather M, Taggart DP; ART Investigators. Comparison of Long-term Clinical Outcomes of Skeletonized vs Pedicled Internal Thoracic Artery Harvesting Techniques in the Arterial Revascularization Trial. JAMA Cardiol. 2021 Dec 1;6(12):1380-1386. doi: 10.1001/jamacardio.2021.3866.
Results Reference
background

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Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

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