Actively Recruiting
Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery
Led by Medical University Innsbruck · Updated on 2024-03-15
1350
Participants Needed
8
Research Sites
394 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary isolated CABG patients with multi-vessel disease defined as 70% stenosis of the left anterior descending artery and 50% stenosis of circumflex and right coronary territories, with or without 50% stenosis of the left main artery
You will not qualify if you...
- Age greater than 80 years
- Planned CABG surgery without use of the left internal thoracic artery
- Preoperative mediastinal radiation therapy
- Emergency operation
- Minimally invasive coronary artery bypass surgery
- Any additional cardiac or non-cardiac surgical procedures
- Previous cardiac surgery
- Known allergy to contrast agents
- Severe stenosis of the left subclavian artery or left-sided subclavian steal syndrome
- Chronic kidney disease with GFR less than 60 ml/min/1.73 m8
- Life expectancy less than 5 years
- Pregnancy
- Hyperthyroidism
- Iodine allergy
- Intraoperative exclusions including Y/T graft off the LITA graft, LITA sequential grafting, or LITA target vessel other than the left anterior descending artery
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Medical University of Graz
Graz, Austria
Not Yet Recruiting
2
Medical University of Innsbruck
Innsbruck, Austria
Actively Recruiting
3
Medical University of Vienna
Vienna, Austria
Not Yet Recruiting
4
University of Duisburg-Essen
Essen, Germany
Not Yet Recruiting
5
University of Freiburg
Freiburg im Breisgau, Germany
Not Yet Recruiting
6
University Hospital Gießen
Giessen, Germany
Not Yet Recruiting
7
University of Jena
Jena, Germany
Not Yet Recruiting
8
University Hospital Bern
Bern, Switzerland
Not Yet Recruiting
Research Team
H
Hannes Abfalterer, Dr. med. univ.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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