Heart Attack, RevascularizationVest IINCT06629701
A Prospective Randomized Trial of External Vein Graft Support in Surgical Myocardial Revascularization
A study testing External support for vein grafts in people with Heart Attack, Revascularization, run by University Hospital Pilsen at 1 site in Czechia.
Trial summary
The aim of the thesis is to compare a group of patients using vein grafts with and without external support, specifically their patency. This is a prospective study with a follow-up plan of 150 patients, in whom the functionality of the grafts will be monitored at time intervals. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Heart Attack, Revascularization
- What is being tested?
- External support for vein grafts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2024to 31 Dec 2027
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective cardiosurgical revascularization using VSM vein graft, i.e. patients with MVD findings.
Who cannot join
- thromboembolic event in the past, long-term warfarinization, mechanical valves, infection during the procedure, urgent procedure, allergy to contrast material, pregnancy, elevated creatinine. A relative contraindication for exclusion from the study is: VSM varicosity, VSM damage during sampling.The age, gender or weight of the patient has no influence on the indication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of the thesis is to compare a group of patients using vein grafts with and without external support, specifically their patency. This is a prospective study with a follow-up plan of 150 patients, in whom the functionality of the grafts will be monitored at time intervals.
Read the detailed description
One of the most frequently used strategies to restore blood flow in affected coronary arteries in atherosclerotic disease is coronary bypass, or bridging of a narrowed or closed artery and revascularization of the ischemic area of the heart. For coronary artery bypass grafting (CABG), the great saphenous vein (VSM) remains the most commonly used graft, although the longevity of the vein graft is an important limiting factor in monitoring long-term results of CABG. Long-term follow-up found that 25% of vein grafts close within 1 year of surgery, and up to 75% of vein grafts close 10 years after surgery.
External support minimizes pathophysiological processes in the graft. For example, intimal hyperplasia, kinking, graft dilatation or graft suppression and generally improving the hemodynamic flow through the graft should also reduce the formation of thrombus. In this study we follow up the patency and function of vein grafts over a period of 4 years, and compare the resulting data with already available data from other researches.
- Conditions
- Heart Attack, Revascularization
- Being tested
- External support for vein grafts
- Keywords
- Heart attack, revascularization
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External support for vein graftsDevice
Group A will consist of a group of patients who will be sutured with external support for vein grafts.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will consist of a group of patients who will be sutured with external support for vein grafts. Receives: Device: External support for vein grafts |
| Group B | No intervention | Group B will be without sewn-in external supports. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closing of bypass in time
Primary measures will be closing of the bypass in time, if there will be any.
Measured: 3 years after the operation
Secondary outcomes (2)
Chest pain
Chest pain
Measured: 3 years after the operation
Shortness of breath at rest
Shortness of breath at rest
Measured: 3 years after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Attack, RevascularizationStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Pilsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viktor Zlocha, MD, Principal investigator, Head of Cardiac Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629701
- Sponsor's protocol ID
- Vest II
- Acronym
- Vest II
- Status last verified
- Apr 2026
- First submitted
- 1 Oct 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of External Vein Graft Support in Surgical Myocardial Revascularization
- ClinicalTrials.gov ID
- NCT06629701
- Acronym / sponsor ID
- Vest II / Vest II
- Conditions
- Heart Attack, Revascularization
- Keywords
- Heart attack, revascularization
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital PilsenUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Oct 2024 (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.
The aim of the thesis is to compare a group of patients using vein grafts with and without external support, specifically their patency. This is a prospective study with a follow-up plan of 150 patients, in whom the functionality of the grafts will be monitored at time intervals.
Detailed description
One of the most frequently used strategies to restore blood flow in affected coronary arteries in atherosclerotic disease is coronary bypass, or bridging of a narrowed or closed artery and revascularization of the ischemic area of the heart. For coronary artery bypass grafting (CABG), the great saphenous vein (VSM) remains the most commonly used graft, although the longevity of the vein graft is an important limiting factor in monitoring long-term results of CABG. Long-term follow-up found that 25% of vein grafts close within 1 year of surgery, and up to 75% of vein grafts close 10 years after surgery.
External support minimizes pathophysiological processes in the graft. For example, intimal hyperplasia, kinking, graft dilatation or graft suppression and generally improving the hemodynamic flow through the graft should also reduce the formation of thrombus. In this study we follow up the patency and function of vein grafts over a period of 4 years, and compare the resulting data with already available data from other researches.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: External support for vein graftsGroup A will consist of a group of patients who will be sutured with external support for vein grafts. |
| Group B | No intervention | –Group B will be without sewn-in external supports. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective cardiosurgical revascularization using VSM vein graft, i.e. patients with MVD findings.
Key exclusion criteria (1 listed)
- thromboembolic event in the past, long-term warfarinization, mechanical valves, infection during the procedure, urgent procedure, allergy to contrast material, pregnancy, elevated creatinine. A relative contraindication for exclusion from the study is: VSM varicosity, VSM damage during sampling.The age, gender or weight of the patient has no influence on the indication.
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 |
|---|---|---|
| External support for vein graftsGroup A will consist of a group of patients who will be sutured with external support for vein grafts. | Device | Group A |
Primary outcome
Closing of bypass in time
Time frame: 3 years after the operation
Primary measures will be closing of the bypass in time, if there will be any.
2 secondary outcomes
Chest pain
Time frame: 3 years after the operation
Shortness of breath at rest
Time frame: 3 years after the operation
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 9 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Viktor Zlocha, MD principal investigator
Head of Cardiac Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External support for vein grafts in people with Heart Attack, Revascularization, run by University Hospital Pilsen at 1 site in Czechia.
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 1 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: enrolling by invitation, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Closing of bypass in time (time frame: 3 years after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2026.