Coronary Artery DiseaseNCT04761068
Clinical Outcomes of Patients Undergoing CABG Surgery With VEST Supported Venous Grafts
An observational study of Coronary Artery Disease, run by Cardiocentro Ticino at 13 sites in 5 countries.
Trial summary
This is a prospective, investigator-initiated, multi-center, open label and post-market registry, enrolling patients with atherosclerotic coronary artery disease, scheduled for CABG with at least one SVG bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- VEST
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 15 Dec 2017to 30 Mar 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient scheduled for planned CABG procedure with at least one SVG bypass with pre-planned VEST treatment
Who may be able to join
- Patient scheduled for planned CABG procedure with at least one SVG bypass with pre-planned VEST treatment.
- Saphenous vein graft length and diameter are adequate for the planned intervention.
- Patient is willing and able to give their written informed consent to participate in the registry study.
- Patient is over 18 years of age
Who cannot join
- Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Austria3 sites, 3 recruiting
- Recruiting
Medical University of Innsbruck
Innsbruck
Nikolaus Bonaros, MD
- Recruiting
AKH (Vienna General Hospital)
Vienna
Sigrid Sandner, MD
- Recruiting
Floridsdorf Clinic
Vienna
Martin Grabenwoger, MD
Germany3 sites, 2 recruiting
- Terminated
Herzzentrum Dresden
Dresden
- Recruiting
Klinikum Nürnberg
Nuremberg
Theodor Fischlein, MD
- Recruiting
Krankenhaus der Barmherzigen Brüder
Trier
Ivar Friedrich, MD
Spain3 sites, 3 recruiting
- Recruiting
Germans Trias i Pujol
Badalona
Christian Muñoz, MD
- Recruiting
University hospital of the Canary Islands
Santa Cruz de Tenerife
Pilar Garrido, MD
- Recruiting
Ribera hospital
Valencia
Juan Antonio Margarit, MD
Italy2 sites, 2 recruiting
- Recruiting
European hospital
Roma
Luca Waltert, MD
- Recruiting
Mauriziano Hospital
Turin
Paolo Centofanti, MD
Switzerland2 sites, 2 recruiting
- Recruiting
Cardiocentro Ticino
Lugano
Stefanos Demertzis, Professor
Stefanos Demertzis, Professor
- Recruiting
Triemli University Hospital
Zurich
Omer Dzemali, MD
About this study
Official title: Clinical Outcomes of Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery With VEST Supported Venous Grafts
This is a prospective, investigator-initiated, multi-center, open label and post-market registry, enrolling patients with atherosclerotic coronary artery disease, scheduled for CABG with at least one SVG bypass.
The registry is designed to evaluate the clinical outcome of CABG surgery with an external support device (VEST) for SVG bypasses.
In each patient, use of the VEST will be according to its approved indications for use and attempt will be made (based on clinical judgement) to support each non-sequential SVG bypass graft with a VEST device.
Subjects will be followed for 5 years, with interim follow ups at 12 and 24 months.
MACCE and EQ5D3L will be documented at every follow up visit.
- Conditions
- Coronary Artery Disease
- Being tested
- VEST
- Keywords
- Coronary artery bypass surgery, CABG, External support
- 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.
VESTDevice
Venous External Support for vein grafts in CABG
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic driven target vessel revascularization
CABG or PCI of VEST supported vein graft or associated target coronary artery
Measured: 5 years post Index CABG
Secondary outcomes (4)
MACCE
The occurrence of any of the following major adverse cardiac and cerebrovascular events (MACCE): death; Stroke; Myocardial infarction (MI) and Coronary revascularization (redo-CABG and PCI).
Measured: 1, 2, and 5 years post index CABG
Myocardial Infarction (MI)
Myocardial Infarction (MI)
Measured: 1, 2, and 5 years post index CABG
Recurrent revascularization
Recurrent revascularization
Measured: 1, 2, and 5 years post index CABG
Survival
Survival, both overall and freedom from cardiac death
Measured: 1, 2, and 5 years post index CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start15 Dec 2017
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Cardiocentro Ticino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefanos Demertzis, Cardiocentro Ticino
- Investigators
- Stefanos Demertzis, Principal investigator, Cardiocentro Ticino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761068
- Sponsor's protocol ID
- VEST registry
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 18 Feb 2021
- 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 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery With VEST Supported Venous Grafts
- ClinicalTrials.gov ID
- NCT04761068
- Acronym / sponsor ID
- VEST registry
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery bypass surgery, CABG, External support
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cardiocentro TicinoUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 18 Feb 2021 (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.
This is a prospective, investigator-initiated, multi-center, open label and post-market registry, enrolling patients with atherosclerotic coronary artery disease, scheduled for CABG with at least one SVG bypass.
The registry is designed to evaluate the clinical outcome of CABG surgery with an external support device (VEST) for SVG bypasses.
In each patient, use of the VEST will be according to its approved indications for use and attempt will be made (based on clinical judgement) to support each non-sequential SVG bypass graft with a VEST device.
Subjects will be followed for 5 years, with interim follow ups at 12 and 24 months.
MACCE and EQ5D3L will be documented at every follow up visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient scheduled for planned CABG procedure with at least one SVG bypass with pre-planned VEST treatment
Key inclusion criteria (4 listed)
- Patient scheduled for planned CABG procedure with at least one SVG bypass with pre-planned VEST treatment.
- Saphenous vein graft length and diameter are adequate for the planned intervention.
- Patient is willing and able to give their written informed consent to participate in the registry study.
- Patient is over 18 years of age
Key exclusion criteria (2 listed)
- Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
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 |
|---|---|---|
| VESTVenous External Support for vein grafts in CABG | Device | – |
Primary outcome
Ischemic driven target vessel revascularization
Time frame: 5 years post Index CABG
CABG or PCI of VEST supported vein graft or associated target coronary artery
4 secondary outcomes
MACCE
Time frame: 1, 2, and 5 years post index CABG
Myocardial Infarction (MI)
Time frame: 1, 2, and 5 years post index CABG
Recurrent revascularization
Time frame: 1, 2, and 5 years post index CABG
Survival
Time frame: 1, 2, and 5 years post index CABG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- 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. This study is not recruiting at the moment.
Stefanos Demertzis principal investigator
Cardiocentro Ticino
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Cardiocentro Ticino at 13 sites in 5 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Austria, Germany, Spain, Italy, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefanos Demertzis, Professor (+41918053147, Stefanos.Demertzis@cardiocentro.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic driven target vessel revascularization (time frame: 5 years post Index CABG). 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 18 Feb 2021.