Coronary Artery DiseaseHARVITANCT05931783
Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery
A study testing skeletonized harvesting technique and pedicled harvesting technique in people with Coronary Artery Disease, run by Medical University Innsbruck at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- skeletonized harvesting technique and pedicled harvesting technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,350 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 12 Mar 2024to 1 Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
Germany4 sites, 4 recruiting
- Not yet recruiting
University of Duisburg-Essen
Essen
Matthias Thielmann, Univ. Prof. Dr.
- Not yet recruiting
University of Freiburg
Freiburg im Breisgau
Martin Czerny, Univ. Prof. Dr.
- Not yet recruiting
University Hospital Gießen
Giessen
Andreas Böning, Univ. Prof. Dr.
- Not yet recruiting
University of Jena
Jena
Torsten Doenst, Univ. Prof. Dr.
Austria3 sites, 3 recruiting
- Not yet recruiting
Medical University of Graz
Graz
Daniel Zimpfer, Univ. Prof. Dr.
- Recruiting
Medical University of Innsbruck
Innsbruck
Hannes Abfalterer, Dr. med. univ.
- Not yet recruiting
Medical University of Vienna
Vienna
Sigrid Sandner, Assoz. Prof. Priv. Doz. Dr.
Switzerland1 site, 1 recruiting
- Not yet recruiting
University Hospital Bern
Bern
Matthias Siepe, Univ. Prof. Dr.
About this study
Official title: Randomized Comparison of HARVesting the Left Internal Thoracic Artery in a Skeletonized Versus Pedicled Technique: the HARVITA Trial
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
- Coronary Artery Disease
- Being tested
- skeletonized harvesting technique, pedicled harvesting technique
- Keywords
- CABG, LITA, graft patency, skeletonized vs. pedicled
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skeletonized harvesting techniqueProcedure or surgery
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 techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| skeletonized harvesting technique | Active comparator | In skeletonized harvesting technique, only the left internal artery itself is harvested. Receives: Procedure: skeletonized harvesting technique |
| pedicled harvesting technique | Active comparator | 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. Receives: Procedure: pedicled harvesting technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years (+/- 3 months) after surgery
Secondary outcomes (1)
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.
Measured: 1 year, 2 years and 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start12 Mar 2024
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannes Abfalterer, Dr. med. univ., Principal investigator, Medical University InnsbruckNikolaos Bonaros, Univ. Prof. Dr., Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931783
- Sponsor's protocol ID
- 1135/2023
- Acronym
- HARVITA
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34132753Gaudino 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.
PubMed 34586338
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of HARVesting the Left Internal Thoracic Artery in a Skeletonized Versus Pedicled Technique: the HARVITA Trial
- ClinicalTrials.gov ID
- NCT05931783
- Acronym / sponsor ID
- HARVITA / 1135/2023
- Conditions
- Coronary Artery Disease
- Keywords
- CABG, LITA, graft patency, skeletonized vs. pedicled
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| skeletonized harvesting technique | Active comparator | Procedure: skeletonized harvesting techniqueIn skeletonized harvesting technique, only the left internal artery itself is harvested. |
| pedicled harvesting technique | Active comparator | Procedure: pedicled harvesting techniqueIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (18 listed)
- Age > 80 years
- Planned CABG without LITA use
- Preoperative mediastinal radiation therapy
- Emergency operation
- Minimal invasive coronary artery bypass surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skeletonized harvesting techniqueIn 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. | Procedure or surgery | skeletonized harvesting technique |
| pedicled harvesting techniqueIn 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. | Procedure or surgery | pedicled harvesting technique |
Primary outcome
Death or LITA graft occlusion in cCTA or invasive angiography within 2 years (+/- 3 months) after surgery.
Time frame: 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.
1 secondary outcome
composite outcome of all-cause death, myocardial infarction and repeated revascularization
Time frame: 1 year, 2 years and 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 34132753Lamy 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.
- Background: PubMed 34586338Gaudino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hannes Abfalterer, Dr. med. univ. principal investigator
Medical University Innsbruck
Nikolaos Bonaros, Univ. Prof. Dr. principal investigator
Medical University Innsbruck
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skeletonized harvesting technique and pedicled harvesting technique in people with Coronary Artery Disease, run by Medical University Innsbruck at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannes Abfalterer, Dr. med. univ. (004351250482988, hannes.abfalterer@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or LITA graft occlusion in cCTA or invasive angiography within 2 years (+/- 3 months) after surgery. (time frame: 2 years (+/- 3 months) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05931783, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.