Aneurysm, DissectingPhase 3NCT00757003
To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
A Phase 3 study testing Endovascular Stent-graft repair of descending thoracic aorta in people with Aneurysm, Dissecting and Aortic Aneurysm, Thoracic, run by Stanford University at 1 site in United States.
Trial summary
PURPOSE OF RESEARCH: Endovascular stent-graft repair of aortic pathologies is a minimally-invasive alternative to open surgery that may decrease morbidity and mortality, particularly in high risk patients. Optimal patient selection, based on pathology and anatomy, is being defined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm, Dissecting, Aortic Aneurysm, Thoracic
- What is being tested?
- Endovascular Stent-graft repair of descending thoracic aorta
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to May 2014
- Phase
- Phase 3
- 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
- Patients should be poor or high risk open surgical candidates.
- Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transection.
- Anatomy meets TAG Endoprosthesis specification criteria.
- Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm
- <60 angle in the aortic arch may require additional length of non-aneurysmal segment is the arch is included in the treatment segment.
- Ability to comply with protocol requirements including follow-up.
- Signed Informed Consent
Who cannot join
- >4mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta.
- Significant thrombus at the proximal or distal implantation sites.
- Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit or alternate perfusion routes for end organ(s) provided.
- Degenerative connective tissue disease, e.g. Marfan's or Ehler's Danlos Syndrome, unless the proximal and distal implantation sites of the TAG Endoprosthesis are located with in previous surgical grafts.
- 6. Female of child bearing age with positive pregnancy test.
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: A Clinical Study of the TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Diseases for Non-Surgical Candidates Under the Physician Sponsored IDE.
PURPOSE OF RESEARCH:
Endovascular stent-graft repair of aortic pathologies is a minimally-invasive alternative to open surgery that may decrease morbidity and mortality, particularly in high risk patients. Optimal patient selection, based on pathology and anatomy, is being defined. Technically successful implantation requires adequate assessment of pathology and anatomy, and development and execution of novel and delicate procedures that resolve the pathology while minimizing morbidity and mortality.
Read the detailed description
STUDY DESCRIPTION:
There will be a maximum of 100 patients treated with the new device. You will be evaluated by your doctor to determine if you are able to participate in this research study. This evaluation will include reviewing your medical history, a physical examination, and special x-rays. These special x-rays are called CT scans and angiograms. Your doctor will explain what tests you will have done. A CT scan is a special x-ray that allows your doctor to see the size and shape of your aorta and your arteries. An angiogram uses a catheter (a hollow tube) that is placed into your arteries. Both tests use dye that can be seen on x-rays to see how the blood flows through your aorta and the surrounding arteries; for the CT scan it will be injected into a vein, and for the angiogram it is injected through the catheter into your arteries. These tests would be conducted whether or not you were participating in this research study. Your doctor will use this type of testing to determine if you are eligible to participate in this research study and as part of your follow-up care. Currently there are two aortic stent grafts manufactured by W.L. Gore \& Associates that are approved by the FDA for experimental use. Your doctor will determine which device is more appropriate to treat your condition.
- Conditions
- Aneurysm, Dissecting, Aortic Aneurysm, Thoracic
- Being tested
- Endovascular Stent-graft repair of descending thoracic aorta
- Medical subject headings
- Aortic Dissection, Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Stent-graft repair of descending thoracic aortaDevice
A TAG device will be used to repair the pathology in the thoracic aorta
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm - Placement of TAG device | Experimental | A TAG device will be used to repair the pathology in the thoracic aorta Receives: Device: Endovascular Stent-graft repair of descending thoracic aorta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Technically Successful Implant
The percentage of participants with technically successful implantation as assessed by the investigator is reported.
Measured: Day 0 to Day 30
Secondary outcomes (2)
Count of Participants Experiencing at Least One Endoleak Following Procedure
Endoleak is persistent blood flow in the aneurysm sac.
Measured: Up to 60 months following procedure
Overall Survival
Overall survival is reported as the count of participants alive 60 months following implant procedure.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startOct 2001
- Primary completionJul 2013
- Study completionMay 2014
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 Aneurysm, DissectingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Yung-Ho Sze, Stanford University
- Investigators
- Daniel Yung-Ho Sze, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757003
- Sponsor's protocol ID
- SU-09112008-1299
- Other IDs
- 13335 (SQL 73498)
- Status last verified
- Jan 2017
- First submitted
- 18 Sep 2008
- Last updated
- 1 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data is made available upon request to colleagues conducting similar studies throughout the US.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Diseases for Non-Surgical Candidates Under the Physician Sponsored IDE.
- ClinicalTrials.gov ID
- NCT00757003
- Acronym / sponsor ID
- SU-09112008-1299
- Conditions
- Aneurysm, Dissecting, Aortic Aneurysm, Thoracic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2001
- Primary completion
- Jul 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Posted 1 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PURPOSE OF RESEARCH:
Endovascular stent-graft repair of aortic pathologies is a minimally-invasive alternative to open surgery that may decrease morbidity and mortality, particularly in high risk patients. Optimal patient selection, based on pathology and anatomy, is being defined. Technically successful implantation requires adequate assessment of pathology and anatomy, and development and execution of novel and delicate procedures that resolve the pathology while minimizing morbidity and mortality.
Detailed description
STUDY DESCRIPTION:
There will be a maximum of 100 patients treated with the new device. You will be evaluated by your doctor to determine if you are able to participate in this research study. This evaluation will include reviewing your medical history, a physical examination, and special x-rays. These special x-rays are called CT scans and angiograms. Your doctor will explain what tests you will have done. A CT scan is a special x-ray that allows your doctor to see the size and shape of your aorta and your arteries. An angiogram uses a catheter (a hollow tube) that is placed into your arteries. Both tests use dye that can be seen on x-rays to see how the blood flows through your aorta and the surrounding arteries; for the CT scan it will be injected into a vein, and for the angiogram it is injected through the catheter into your arteries. These tests would be conducted whether or not you were participating in this research study. Your doctor will use this type of testing to determine if you are eligible to participate in this research study and as part of your follow-up care. Currently there are two aortic stent grafts manufactured by W.L. Gore \& Associates that are approved by the FDA for experimental use. Your doctor will determine which device is more appropriate to treat your condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm - Placement of TAG device | Experimental | Device: Endovascular Stent-graft repair of descending thoracic aortaA TAG device will be used to repair the pathology in the thoracic aorta |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients should be poor or high risk open surgical candidates.
- Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transection.
- Anatomy meets TAG Endoprosthesis specification criteria.
- Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm
- Ability to comply with protocol requirements including follow-up.
Key exclusion criteria (5 listed)
- >4mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta.
- Significant thrombus at the proximal or distal implantation sites.
- Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit or alternate perfusion routes for end organ(s) provided.
- Degenerative connective tissue disease, e.g. Marfan's or Ehler's Danlos Syndrome, unless the proximal and distal implantation sites of the TAG Endoprosthesis are located with in previous surgical grafts.
- 6. Female of child bearing age with positive pregnancy test.
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 Stent-graft repair of descending thoracic aortaA TAG device will be used to repair the pathology in the thoracic aorta | Device | Treatment Arm - Placement of TAG device |
Primary outcome
Percentage of Participants With Technically Successful Implant
Time frame: Day 0 to Day 30
The percentage of participants with technically successful implantation as assessed by the investigator is reported.
2 secondary outcomes
Count of Participants Experiencing at Least One Endoleak Following Procedure
Time frame: Up to 60 months following procedure
Overall Survival
Time frame: 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data is made available upon request to colleagues conducting similar studies throughout the US.
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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.
Daniel Yung-Ho Sze principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endovascular Stent-graft repair of descending thoracic aorta in people with Aneurysm, Dissecting and 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 7 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: finished, as of the sponsor's last update on 1 Mar 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2017). 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?
Percentage of Participants With Technically Successful Implant (time frame: Day 0 to Day 30). 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 1 Mar 2017.