Aortic Aneurysm, ThoracicPhase 4NCT00802984
Endovascular Repair of Descending Thoracic Aortic Aneurysms
A Phase 4 study testing Endovascular thoracic aortic aneurysm repair using TALENT TAA Stent Graft System in people with Aortic Aneurysm, Thoracic, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the system is safe and effective for the intended use of treating descending thoracic aortic aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Thoracic
- What is being tested?
- Endovascular thoracic aortic aneurysm repair using TALENT TAA Stent Graft System
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Dec 2005
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a candidate for repair of a descending thoracic aortic aneurysm.
- Patient has one or more of the following:
- Descending thoracic aneurysm, 5 cm in diameter or greater with proximal and distal neck suitable for stent graft placement.
- Aneurysm is 4-5 cm in diameter but has increased in size by 0.5 cm in last 6 months.
- Maximum diameter of aneurysm exceeds one and one-half times the transverse dimension of an adjacent normal aortic segment.
- Post-traumatic pseudoaneurysm
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- Post-surgical pseudoaneurysm
- Saccular aneurysm
- Contained rupture
- Penetrating ulcer
- Patient's vascular dimensions must be in the range that can be safely treated with the stent graft and extensions available to the physician at the time of the procedure.
- Patient has patent iliac or femoral arteries or acceptable retroperitoneal access via the abdominal aorta that allow endovascular access to the aneurysmal site with a 23F delivery catheter, typically used with a 25F introducer sheath
- Patient has a non-aneurysmal proximal and distal aortic neck diameter between 25 and 36 mm.
- Patient is American Society of Anesthesiology (ASA) grade 1 through 4.
- Patient has a stage of disease or condition where there is no comparable or satisfactory alternative device or therapy available for treatment; or the patient has an immediately life-threatening disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.
- Patient is able and willing to comply with 1 month, 6 month, and 1 year follow-up, and willing to comply with annual post-treatment follow-up requirements thereafter.
- Patient or patient's legal representative understands and has signed an Informed Consent.
Who cannot join
- The stent graft would have to be positioned such that there would be no flow to an artery, major branch artery or major branch arteries which supply the spinal cord.
- The patient has congenital abnormalities in which the placement of the stent graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated prior to treatment.
- Patient is pregnant.
- Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
- Patient has connective tissue disease.
- Patient has a hypercoagulability disorder.
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- Patient is in acute renal failure.
- Patient has active systemic infection.
- Patient is less than 18 years old.
- Patient has less than a one-year life expectancy.
- Patient is participating in another research study involving an investigational agent for the treatment of Descending Thoracic Aortic Aneurysms.
- Patient has other medical, social or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
- Patient is unwilling or unable to return for or comply with follow-up visit schedules.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Endovascular Treatment of Thoracic Aortic Aneurysms Using the TALENT Stent Graft System
The purpose of this study is to determine whether the system is safe and effective for the intended use of treating descending thoracic aortic aneurysms.
- Conditions
- Aortic Aneurysm, Thoracic
- Being tested
- Endovascular thoracic aortic aneurysm repair using TALENT TAA Stent Graft System
- 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.
Endovascular thoracic aortic aneurysm repair using TALENT TAA Stent Graft SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent graft migration
Vessel Dissection or perforation
Stent graft occlusion
Collateral vessel occlusion
Aneurysm rupture
Aneurysm exclusion
Secondary outcomes (2)
Technical success
Patency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startJan 2002
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, ThoracicStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher K Zarins, MD, Principal investigator, Stanford UniversityJason T Lee, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802984
- Sponsor's protocol ID
- SU-11092007-868
- Other IDs
- IRB Protocol Number 77836
- Status last verified
- Oct 2020
- First submitted
- 4 Dec 2007
- Last updated
- 8 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment of Thoracic Aortic Aneurysms Using the TALENT Stent Graft System
- ClinicalTrials.gov ID
- NCT00802984
- Acronym / sponsor ID
- SU-11092007-868
- Conditions
- Aortic Aneurysm, Thoracic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2002 (actual)
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 5 Dec 2008 (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 purpose of this study is to determine whether the system is safe and effective for the intended use of treating descending thoracic aortic aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient is a candidate for repair of a descending thoracic aortic aneurysm.
- Patient has one or more of the following:
- Patient's vascular dimensions must be in the range that can be safely treated with the stent graft and extensions available to the physician at the time of the procedure.
- Patient has patent iliac or femoral arteries or acceptable retroperitoneal access via the abdominal aorta that allow endovascular access to the aneurysmal site with a 23F delivery catheter, typically used with a 25F introducer sheath
- Patient has a non-aneurysmal proximal and distal aortic neck diameter between 25 and 36 mm.
Key exclusion criteria (13 listed)
- The stent graft would have to be positioned such that there would be no flow to an artery, major branch artery or major branch arteries which supply the spinal cord.
- The patient has congenital abnormalities in which the placement of the stent graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated prior to treatment.
- Patient is pregnant.
- Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
- Patient has connective tissue disease.
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 |
|---|---|---|
| Endovascular thoracic aortic aneurysm repair using TALENT TAA Stent Graft System | Device | – |
Primary outcome
Stent graft migration
Vessel Dissection or perforation
Stent graft occlusion
Collateral vessel occlusion
Aneurysm rupture
Aneurysm exclusion
2 secondary outcomes
Technical success
Patency
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 8 Oct 2020.
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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.
Christopher K Zarins, MD principal investigator
Stanford University
Jason T Lee, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endovascular thoracic aortic aneurysm repair using TALENT TAA Stent Graft System in people with Aortic Aneurysm, Thoracic, run by Stanford University at 1 site 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 17 inclusion and 13 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 8 Oct 2020. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Stent graft migration. The study lists 6 primary outcomes in all. 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 8 Oct 2020.