NCT05931783Recruiting
Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery
Randomized Comparison of HARVesting the Left Internal Thoracic Artery in a Skeletonized Versus Pedicled Technique: the HARVITA Trial
Source: ClinicalTrials.gov · Last updated 15 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1350 (estimated)
- First submitted
- 22 Jun 2023
- Start date
- 12 Mar 2024
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- Medical University Innsbruck
- Diseases
- Coronary artery disease
- NCT number
- NCT05931783
What you commit to
- Study type: Interventional
- Planned participants: 1350
- From 12 Mar 2024 to the primary completion date, 1 Oct 2028
- 8 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Preoperative mediastinal radiation therapy
- Minimal invasive coronary artery bypass surgery
- Any concomitant cardiac or non-cardiac procedures
- Previous cardiac surgery
Other illness
- Known contrast agent allergy
- Severe stenosis of the left subclavian artery/ left-sided subclavian steal syndrome
- Iodine allergy
- Intraoperative exclusion criteria:
Lab values
- Chronic kidney disease (GFR \<60ml/min/1.73m²)
Age
- Age \> 80 years
Other
- Planned CABG without LITA use
- Emergency operation
- Life expectancy of less than 5 years
- Pregnancy
- Hyperthyroidism
- Y/T graft off the LITA graft
- LITA sequential grafting
- LITA target vessel other than LAD
Who the study is looking for
- 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).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Not yet recruiting |
| Medical University of Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| University Hospital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Not yet recruiting |
| University of Duisburg-Essen Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Not yet recruiting |
| University Hospital Gießen Coordinator of this site? Confirm its status | Giessen | Germany | Not yet recruiting |
| University of Jena Coordinator of this site? Confirm its status | Jena | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.