Coronary Artery DiseaseNCT01860274
Meshed Vein Graft Patency Trial - VEST
A study testing External Mesh for vein grafts in people with Coronary Artery Disease, run by Cardiochirurgia E.H. at 2 sites in Italy.
Trial summary
The study hypothesis is that a meshed conduit made of safen vein allows a better patency at mid-long term than a safen vein alone. To test this hypothesis the investigators plan a prospective, randomized study, comparing grafts to the diagonal, in cases of vessel diameter under 1.5mm. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- External Mesh for vein grafts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesItaly
- Study dates
- 6 Sep 2015to 28 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical Indication for elective Coronary Artery Bypass Grafting with at least one vein graft
- Coronary artery with critical stenosis (over 70%)
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: External Mesh of Vein Grafts In Coronary Artery Bypass Grating: Early Patency and Clinical Outcome
The study hypothesis is that a meshed conduit made of safen vein allows a better patency at mid-long term than a safen vein alone.
To test this hypothesis the investigators plan a prospective, randomized study, comparing grafts to the diagonal, in cases of vessel diameter under 1.5mm. A control angiography will be performed one year after the operation.
- Conditions
- Coronary Artery Disease
- Being tested
- External Mesh for vein grafts
- Keywords
- Mesh, Graft, Patency
- 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.
External Mesh for vein graftsDevice
| Study group | Role | What they receive |
|---|---|---|
| External Mesh | Experimental | Not described Receives: Device: External Mesh for vein grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency
Patency of graft at CT Scan
Measured: 6 to 12 months
Secondary outcomes (2)
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Measured: 60 months
Vein graft lumen uniformity
Measured: 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study start6 Sep 2015
- Primary completion31 Dec 2019
- Study completion28 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiochirurgia E.H.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Weltert, MD, Principal investigator, European Hospital - RomeRuggero De Paulis, MD, Study chair, European Hospital - Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860274
- Sponsor's protocol ID
- 00-06
- Status last verified
- Mar 2021
- First submitted
- 20 May 2013
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weltert LP, Audisio K, Bellisaro A, Bardi G, Flocco R, De Paulis R, Centofanti P. External stenting of vein grafts in coronary artery bypass grating: interim results from a two centers prospective study. J Cardiothorac Surg. 2021 Apr 12;16(1):74. doi: 10.1186/s13019-021-01406-0.
PubMed 33845865
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Mesh of Vein Grafts In Coronary Artery Bypass Grating: Early Patency and Clinical Outcome
- ClinicalTrials.gov ID
- NCT01860274
- Acronym / sponsor ID
- 00-06
- Conditions
- Coronary Artery Disease
- Keywords
- Mesh, Graft, Patency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Cardiochirurgia E.H.University, hospital or other
- Study start
- 6 Sep 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 28 Jun 2020 (actual)
- First posted
- 22 May 2013 (estimated)
- 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 study hypothesis is that a meshed conduit made of safen vein allows a better patency at mid-long term than a safen vein alone.
To test this hypothesis the investigators plan a prospective, randomized study, comparing grafts to the diagonal, in cases of vessel diameter under 1.5mm. A control angiography will be performed one year after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| External Mesh | Experimental | Device: External Mesh for vein grafts |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical Indication for elective Coronary Artery Bypass Grafting with at least one vein graft
- Coronary artery with critical stenosis (over 70%)
Key exclusion criteria (1 listed)
- -
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 Mesh for vein grafts | Device | External Mesh |
Primary outcome
Patency
Time frame: 6 to 12 months
Patency of graft at CT Scan
2 secondary outcomes
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: 60 months
Vein graft lumen uniformity
Time frame: 6 to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Derived from this study: PubMed 33845865Weltert LP, Audisio K, Bellisaro A, Bardi G, Flocco R, De Paulis R, Centofanti P. External stenting of vein grafts in coronary artery bypass grating: interim results from a two centers prospective study. J Cardiothorac Surg. 2021 Apr 12;16(1):74. doi: 10.1186/s13019-021-01406-0.
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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. This study is not recruiting at the moment.
Luca Weltert, MD principal investigator
European Hospital - Rome
Ruggero De Paulis, MD study chair
European Hospital - Rome
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Mesh for vein grafts in people with Coronary Artery Disease, run by Cardiochirurgia E.H. at 2 sites in Italy.
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 2 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: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patency (time frame: 6 to 12 months). 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 NCT01860274, which also lists 1 linked publication.
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 12 Mar 2021.