Thoracic Aortic AneurysmsTHRIVENCT00805948
Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)
A study testing Talent Thoracic Stent Graft System in people with Thoracic Aortic Aneurysms, run by Medtronic Cardiovascular at 26 sites in United States.
Trial summary
The purpose of this study is to evaluate the long-term safety and effectiveness of the Talent Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following U.S. market approval. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysms
- What is being tested?
- Talent Thoracic Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 26 sitesUnited States
- Study dates
- Apr 2009to Aug 2017
- Phase
- Interventional
- 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
Who may be able to join
None listed.
Who cannot join
- Less than 18 yrs old
- pregnant
- unable to comply w/follow-up
- participating in other drug or device trials;
- Subject has a co-morbidity causing expected survival to be less than 1 year
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Albany Medical Center
Albany, New York, 12208
Emory University
Atlanta, Georgia, 30322
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Memorial Hospital
Chattanooga, Tennessee, 37404
Northwestern MH
Chicago, Illinois, 60611
Riverside Methodist Hospital
Columbus, Ohio, 43214
Duke University Medical Center
Durham, North Carolina, 27710
U Florida at Shands Hospital
Gainesville, Florida, 32610
Northwell Health Inc
Great Neck, New York, 11021
Baylor College of Medicine
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
St. Vincent Heart Center
Indianapolis, Indiana, 46290
Osceola Regional Med Ctr
Kissimmee, Florida, 34741
Cedars Sinai Medical Center
Los Angeles, California, 90048
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Sentara Norfolk General Vascular & Transplant Specialists
Norfolk, Virginia, 23507
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
The Heart Hospital/Baylor Plano
Plano, Texas, 38120
Tennova Physicians Regional Medical Center
Powell, Tennessee, 37849
University of Washington
Seattle, Washington, 98195
Providence Sacred Heart
Spokane, Washington, 99204
Southern Illinois University
Springfield, Illinois, 62702
University of Toledo Med Ctr
Toledo, Ohio, 43615
Harbor-UCLA
Torrance, California, 90502
Washington Hospital D.C.
Washington D.C., District of Columbia, 20010
Pinnacle Health
Wormleysburg, Pennsylvania, 17043
About this study
Official title: Descending Thoracic Aortic Aneurysm Endovascular Repair Post-approval Study (THRIVE)
The purpose of this study is to evaluate the long-term safety and effectiveness of the Talent Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following U.S. market approval.
Read the detailed description
A descending thoracic aneurysm is a bulge in the aorta. The aorta is a large blood vessel that carries blood away from your heart to organs in the rest of your body. Your aneurysm is caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow larger and may ultimately rupture (break open) or extend in size to seriously affect other major arteries in the area. In this clinical study the Talent Thoracic Stent Graft will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system.
Medtronic Vascular submitted a Pre-Market Application (PMA P070007) to the FDA on February 28, 2007, and received market approval for the Talent Stent Graft System on June 5, 2008. As a condition of approval, the FDA has requested a post-market trial. In collaboration with the FDA, Medtronic has designed a post-approval study to document the long-term performance of the Talent Stent Graft System under post market conditions.
This study will examine the post-market performance of the Talent Thoracic Stent Graft System. This study is a prospective, non-randomized five-year trial. Originally, a total of 451 subjects were going to be analyzed. That group consisted of 195 enrolled subjects from the VALOR Test Group of the Talent Thoracic PMA Submission, and 256 planned "de novo" subjects enrolled after the PMA approval. However, Medtronic discontinued manufacturing of the study device for US commercialization, and as a result, enrollment was terminated in May 2014, when it was determined that no more proximal devices were available either in inventory or at the sites. A total of 349 subjects will be analyzed, based on 195 VALOR Test Group subjects and 154 "de novo" subjects.
Update as of Aug 2017: Medtronic Vascular, Inc. discontinued manufacture of the Talent Thoracic Stet Graft System on 31-Jul-2012, and the final device expired in July 2014 (based on the two-year shelf life). Enrollment for De Novo subjects ended in May 2014, as there were no more proximal main devices available either in inventory or at the investigational sites. This resulted in a total of 349 subjects to be analyzed in this final report: the 195 VALOR subjects and 154 of the planned 256 De Novo subjects. Because of that, statistical results would have been inconclusive, so Medtronic decided to terminate the study and received FDA approval for early termination in April 2016.
It is important to emphasize that THRIVE subjects will continue to be followed-up annually per standard of care and standard post-market surveillance program applies to them (e.g. device complaints will continue to be reported via the MDR (Medical Device Reporting) system.)
- Conditions
- Thoracic Aortic Aneurysms
- Being tested
- Talent Thoracic Stent Graft System
- Keywords
- thoracic aneurysm, thoracic aortic aneurysms, Thoracic Endovascular Aneurysm Repair (TEVAR), Talent Thoracic Stent Graft
- Medical subject headings
- Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talent Thoracic Stent Graft SystemDevice
endovascular repair of descending thoracic aortic aneurysms using the Talent Thoracic Stent Graft System.
| Study group | Role | What they receive |
|---|---|---|
| DeNovo | Experimental | Prospectively enrolled subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device. Receives: Device: Talent Thoracic Stent Graft System |
| Valor | No intervention | Historical control arm, consisting of 195 subjects from the VALOR Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol. The data from these subjects will be combined with the data from the subjects implanted after commercial release (DeNovo) to comprise the final analysis cohort for the THRIVE Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Aneurysm-related Mortality at 5 Years
For all THRIVE subjects, Aneurysm-Related Mortality (ARM) is defined as: Death from rupture of the thoracic aortic aneurysm or from any procedure intended to treat the Descending Thoracic Aneurysm (DTA - fusiform aneurysms and saccular aneurysms/penetrating ulcers) as determined by an independent Clinical Events Committee (CEC). If a death occurred within 30 days of any procedure intended to treat the DTA, then it is presumed to be aneurysm related, unless there is evidence to the contrary.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startApr 2009
- Primary completionAug 2016
- Study completionAug 2017
Why it stopped: Study device discontinued \& insufficient sample size for statistical results.
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.
- Other trials for Thoracic Aortic AneurysmsStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Adam W Beck, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805948
- Sponsor's protocol ID
- Investigational Plan #109
- Acronym
- THRIVE
- Status last verified
- Sep 2021
- First submitted
- 8 Dec 2008
- Last updated
- 27 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descending Thoracic Aortic Aneurysm Endovascular Repair Post-approval Study (THRIVE)
- ClinicalTrials.gov ID
- NCT00805948
- Acronym / sponsor ID
- THRIVE / Investigational Plan #109
- Conditions
- Thoracic Aortic Aneurysms
- Keywords
- thoracic aneurysm, thoracic aortic aneurysms, Thoracic Endovascular Aneurysm Repair (TEVAR), Talent Thoracic Stent Graft
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study device discontinued \& insufficient sample size for statistical results.
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Apr 2009 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 10 Dec 2008 (estimated)
- Results
- Posted 14 Aug 2019
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 study is to evaluate the long-term safety and effectiveness of the Talent Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following U.S. market approval.
Detailed description
A descending thoracic aneurysm is a bulge in the aorta. The aorta is a large blood vessel that carries blood away from your heart to organs in the rest of your body. Your aneurysm is caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow larger and may ultimately rupture (break open) or extend in size to seriously affect other major arteries in the area. In this clinical study the Talent Thoracic Stent Graft will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system.
Medtronic Vascular submitted a Pre-Market Application (PMA P070007) to the FDA on February 28, 2007, and received market approval for the Talent Stent Graft System on June 5, 2008. As a condition of approval, the FDA has requested a post-market trial. In collaboration with the FDA, Medtronic has designed a post-approval study to document the long-term performance of the Talent Stent Graft System under post market conditions.
This study will examine the post-market performance of the Talent Thoracic Stent Graft System. This study is a prospective, non-randomized five-year trial. Originally, a total of 451 subjects were going to be analyzed. That group consisted of 195 enrolled subjects from the VALOR Test Group of the Talent Thoracic PMA Submission, and 256 planned "de novo" subjects enrolled after the PMA approval. However, Medtronic discontinued manufacturing of the study device for US commercialization, and as a result, enrollment was terminated in May 2014, when it was determined that no more proximal devices were available either in inventory or at the sites. A total of 349 subjects will be analyzed, based on 195 VALOR Test Group subjects and 154 "de novo" subjects.
Update as of Aug 2017: Medtronic Vascular, Inc. discontinued manufacture of the Talent Thoracic Stet Graft System on 31-Jul-2012, and the final device expired in July 2014 (based on the two-year shelf life). Enrollment for De Novo subjects ended in May 2014, as there were no more proximal main devices available either in inventory or at the investigational sites. This resulted in a total of 349 subjects to be analyzed in this final report: the 195 VALOR subjects and 154 of the planned 256 De Novo subjects. Because of that, statistical results would have been inconclusive, so Medtronic decided to terminate the study and received FDA approval for early termination in April 2016.
It is important to emphasize that THRIVE subjects will continue to be followed-up annually per standard of care and standard post-market surveillance program applies to them (e.g. device complaints will continue to be reported via the MDR (Medical Device Reporting) system.)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DeNovo | Experimental | Device: Talent Thoracic Stent Graft SystemProspectively enrolled subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device. |
| Valor | No intervention | –Historical control arm, consisting of 195 subjects from the VALOR Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol. The data from these subjects will be combined with the data from the subjects implanted after commercial release (DeNovo) to comprise the final analysis cohort for the THRIVE Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Less than 18 yrs old
- pregnant
- unable to comply w/follow-up
- participating in other drug or device trials;
- Subject has a co-morbidity causing expected survival to be less than 1 year
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 |
|---|---|---|
| Talent Thoracic Stent Graft Systemendovascular repair of descending thoracic aortic aneurysms using the Talent Thoracic Stent Graft System. | Device | DeNovo |
Primary outcome
Freedom From Aneurysm-related Mortality at 5 Years
Time frame: 5 years
For all THRIVE subjects, Aneurysm-Related Mortality (ARM) is defined as: Death from rupture of the thoracic aortic aneurysm or from any procedure intended to treat the Descending Thoracic Aneurysm (DTA - fusiform aneurysms and saccular aneurysms/penetrating ulcers) as determined by an independent Clinical Events Committee (CEC). If a death occurred within 30 days of any procedure intended to treat the DTA, then it is presumed to be aneurysm related, unless there is evidence to the contrary.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Adam W Beck, MD principal investigator
University of Florida
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talent Thoracic Stent Graft System in people with Thoracic Aortic Aneurysms, run by Medtronic Cardiovascular at 26 sites in United States.
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 0 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. 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?
Yes. Results are posted in the registry (first posted 14 Aug 2019). 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?
Freedom From Aneurysm-related Mortality at 5 Years (time frame: 5 years). 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 27 Sep 2021.