Aortic DissectionVIRTUENCT01213589
The VIRTUE Post Marketing Surveillance Registry
An observational study of Aortic Dissection, run by Medtronic Endovascular.
Trial summary
The purpose of this post-market release registry is to collect additional information concerning safety, performance and health economic data with respect to the Medtronic VALIANT Thoracic Stent Graft with the Xcelerant Delivery System in the treatment of descending thoracic aortic dissections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Oct 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation will be enrolled in the registry.
Who may be able to join
- Patient will be more than or equal to 18 years of age; or older if required by local regulations.
- Patient has an indication for treatment by either endovascular stent graft implantation for either an acute, sub-acute or chronic Type B dissection.
- Patient is amenable for stent-graft treatment (in accordance with the IFU).
- The patient is willing and able to cooperate with registry procedures and required follow-up visits.
- The patient or legal guardian has signed a patient informed consent form, including data privacy authorization (this criteria is not applicable for patients presenting in emergency with ruptured dissection and for whom legal representative is not available informed consent can be requested after surgical procedure).
Who cannot join
- Patients with a thoracic dissection for which optimal treatment is observation and medical management.
- Patient with current - non aortic - medical condition with a life expectancy less than one year.
- The patient is participating in another device or drug study (patient must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this registry).
- Time interval between medical indication for surgical intervention and endovascular procedure exceeds 4 months (122 days).
About this study
Official title: The VIRTUE Post Marketing Surveillance Registry - VALIANT Thoracic Stent Graft Evaluation For the Treatment of Descending Thoracic Aortic Dissections
The purpose of this post-market release registry is to collect additional information concerning safety, performance and health economic data with respect to the Medtronic VALIANT Thoracic Stent Graft with the Xcelerant Delivery System in the treatment of descending thoracic aortic dissections.
Read the detailed description
The patient device for use in this registry is the Medtronic VALIANT Thoracic Stent Graft System that received CE mark approval in March 2005.
The Medtronic VALIANT Thoracic Stent Graft with Xcelerant Delivery System is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The VALIANT Stent Graft is designed to exclude the aneurysm, the false lumen or site of rupture and restore the blood flow through the stent graft lumen. The device is intended for use either in patients who are candidates for conventional surgical repair, and in patients who are not candidates for conventional surgical repair due to pre-existing risk factors.
This registry is a prospective, non-randomized, single-arm, multi-center, European clinical registry with patients diagnosed with descending thoracic aortic dissection.
For this registry standard hospital procedures with respect to patient interventional care for thoracic aortic diseases will be followed.
This is a descriptive registry in which no specific hypotheses will be statistically tested.
- Conditions
- Aortic Dissection
- Keywords
- descending, thoracic, aortic, dissection, Valiant, Medtronic, Type B, VIRTUE, stent
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Descending thoracic aortic dissection | Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for either an acute, sub-acute or chronic Type B dissection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure
Disease, device or procedure-related mortality at 12 months post-procedure, defined as any death related to the device, to the disease or to the surgical procedure occurring in the period of 365 days following the day of the implant procedure.
Measured: 12 months post-procedure
Secondary outcomes (6)
Safety
- All causes mortality
- Disease-, procedure- or device-related mortality
Measured: 30 days or at discharge, 3/6/12/24/36 months
Efficacy/Performance
- Technical Success Technical success, defined as a composite of (i) successful introduction and deployment of at least one Valiant Thoracic Stent Graft at the intended location, (ii) successful coverage of the proximal entry tear, (iii) no immediate conversion to open surgery during the same intervention, (iv) absence of death within 24 hours post-procedure, and (v) the absence of significant graft twist, kink or obstruction by intra-operative measurements
Measured: 30 days or at discharge, 3/6/12/24/36 months
Freedom of Re-intervention
Kaplan-Meier estimate of freedom from secondary procedures by clinical group.
Measured: 30 days or at discharge, 3/6/12/24/36 months
Freedom From Disease-, Procedure- or Device-related Major Complications
Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A moderate complication indicates the need for significant intervention, prolongation of hospitalization more than 24 hours, and at most, minor permanent disability that does not preclude normal daily activity. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death. Both moderate and severe complications are considered as major complications.
Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related major complications by clinical group.
Measured: through 36 months
Freedom From Disease-, Procedure-, or Device-related Severe Complications
Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death.
Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related severe complications
Measured: through 36 months
Clinical Success
Clinical success was defined as: (i) successful introduction and deployment of the Valiant Thoracic Stent Graft at the intended location; (ii) successful coverage of the proximal entry tear; (iii) no immediate conversion to open surgery;(iv) absence of surgical open repair or endovascular re-intervention; (v) absence of death related to aortic disease or treatment; (vi) absence of graft thrombosis, obstructions, twists or kinks; (vii) absence of graft migration;(viii) absence of graft integrity failure; (ix) at the level of the ostium of the LSA, the more proximal entry tear of the dissection, the largest section of the thoracic aorta, and at the first image/slice available with upper part of the liver:
Absence of true lumen decrease in diameter (≥ 5 mm is significant) Absence of increase in total aortic diameter (≥ 5 mm is significant)
Measured: through 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startDec 2006
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic DissectionStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M. Thompson, Prof., Principal investigator, St George's HospitalD. Gasparini, Dr., Principal investigator, Azienda Ospedaliera "Santa Maria della Misericordia"R. Fattori, Prof., Principal investigator, Ospedale Sant'Orsola MalpighiP. Cao, Dr., Principal investigator, Unità di Chirurgia Vascolare, Ospedale R. SilvestriniG. Garzón, Dr., Principal investigator, Hospital Universitario La PazE. Ros, Prof., Principal investigator, Hospital Clínico Universitario San CecilioB. Rylski, Dr., Principal investigator, University Hospital FreiburgS. Huptas, Dr., Principal investigator, Universitätsklinikum Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213589
- Sponsor's protocol ID
- MDTVIRTUE001
- Acronym
- VIRTUE
- Status last verified
- Oct 2013
- First submitted
- 1 Oct 2010
- Last updated
- 11 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Virtue Registry Investigators. The VIRTUE Registry of type B thoracic dissections--study design and early results. Eur J Vasc Endovasc Surg. 2011 Feb;41(2):159-66. doi: 10.1016/j.ejvs.2010.08.016. Epub 2010 Oct 16.
PubMed 20952217
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VIRTUE Post Marketing Surveillance Registry - VALIANT Thoracic Stent Graft Evaluation For the Treatment of Descending Thoracic Aortic Dissections
- ClinicalTrials.gov ID
- NCT01213589
- Acronym / sponsor ID
- VIRTUE / MDTVIRTUE001
- Conditions
- Aortic Dissection
- Keywords
- descending, thoracic, aortic, dissection, Valiant, Medtronic, Type B, VIRTUE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Posted 11 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this post-market release registry is to collect additional information concerning safety, performance and health economic data with respect to the Medtronic VALIANT Thoracic Stent Graft with the Xcelerant Delivery System in the treatment of descending thoracic aortic dissections.
Detailed description
The patient device for use in this registry is the Medtronic VALIANT Thoracic Stent Graft System that received CE mark approval in March 2005.
The Medtronic VALIANT Thoracic Stent Graft with Xcelerant Delivery System is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The VALIANT Stent Graft is designed to exclude the aneurysm, the false lumen or site of rupture and restore the blood flow through the stent graft lumen. The device is intended for use either in patients who are candidates for conventional surgical repair, and in patients who are not candidates for conventional surgical repair due to pre-existing risk factors.
This registry is a prospective, non-randomized, single-arm, multi-center, European clinical registry with patients diagnosed with descending thoracic aortic dissection.
For this registry standard hospital procedures with respect to patient interventional care for thoracic aortic diseases will be followed.
This is a descriptive registry in which no specific hypotheses will be statistically tested.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Descending thoracic aortic dissection | – | –Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for either an acute, sub-acute or chronic Type B dissection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation will be enrolled in the registry.
Key inclusion criteria (5 listed)
- Patient will be more than or equal to 18 years of age; or older if required by local regulations.
- Patient has an indication for treatment by either endovascular stent graft implantation for either an acute, sub-acute or chronic Type B dissection.
- Patient is amenable for stent-graft treatment (in accordance with the IFU).
- The patient is willing and able to cooperate with registry procedures and required follow-up visits.
- The patient or legal guardian has signed a patient informed consent form, including data privacy authorization (this criteria is not applicable for patients presenting in emergency with ruptured dissection and for whom legal representative is not available informed consent can be requested after surgical procedure).
Key exclusion criteria (4 listed)
- Patients with a thoracic dissection for which optimal treatment is observation and medical management.
- Patient with current - non aortic - medical condition with a life expectancy less than one year.
- The patient is participating in another device or drug study (patient must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this registry).
- Time interval between medical indication for surgical intervention and endovascular procedure exceeds 4 months (122 days).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure
Time frame: 12 months post-procedure
Disease, device or procedure-related mortality at 12 months post-procedure, defined as any death related to the device, to the disease or to the surgical procedure occurring in the period of 365 days following the day of the implant procedure.
6 secondary outcomes
Safety
Time frame: 30 days or at discharge, 3/6/12/24/36 months
Efficacy/Performance
Time frame: 30 days or at discharge, 3/6/12/24/36 months
Freedom of Re-intervention
Time frame: 30 days or at discharge, 3/6/12/24/36 months
Freedom From Disease-, Procedure- or Device-related Major Complications
Time frame: through 36 months
Freedom From Disease-, Procedure-, or Device-related Severe Complications
Time frame: through 36 months
Clinical Success
Time frame: through 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20952217Virtue Registry Investigators. The VIRTUE Registry of type B thoracic dissections--study design and early results. Eur J Vasc Endovasc Surg. 2011 Feb;41(2):159-66. doi: 10.1016/j.ejvs.2010.08.016. Epub 2010 Oct 16.
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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.
M. Thompson, Prof. principal investigator
St George's Hospital
D. Gasparini, Dr. principal investigator
Azienda Ospedaliera "Santa Maria della Misericordia"
R. Fattori, Prof. principal investigator
Ospedale Sant'Orsola Malpighi
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection, run by Medtronic Endovascular.
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 5 inclusion and 4 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 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 11 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure (time frame: 12 months post-procedure). 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 NCT01213589, 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 11 Dec 2013.