Thoracic Aortic AneurysmPhase 1NCT01033214
ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial
A Phase 1 study testing Endovascular repair of TAA in the descending Thoracic Aorta in people with Thoracic Aortic Aneurysm, run by Duke Vascular, Inc. at 2 sites in United States.
Trial summary
Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysm
- What is being tested?
- Endovascular repair of TAA in the descending Thoracic Aorta
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Dec 2015
- Phase
- Phase 1
- 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
- Subject is > 18 years of age. Female subjects are either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and have a negative serum pregnancy test at screening.
- Subject is a candidate for endovascular thoracic aortic repair.
- Subject has a TAA that meets one of the following criteria:
- Is diagnosed with a Fusiform Focal TAA ≥5cm, or
- Is diagnosed with a Fusiform Focal TAA that has a diameter ≤ 5 cm and has exhibited rapid expansion, or
- Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
Show all 9Show fewer
- Is diagnosed with a saccular TAA of any size (where potential for rupture is increased*).
- Tortuosity and angulation do not exceed 90 degrees.
- Subject has an arterial access site that allows for the introduction of the stent-graft delivery system.
Who cannot join
- Subject has a life expectancy < 2 years.
- Subject has a lesion that prevents safe delivery or expansion of the device.
- Subject has concomitant ascending aortic aneurysm.
- Subject has known allergies to any of the device materials.
- Subject has coagulopathy or bleeding disorders that cannot be pre-treated.
- Subject is contraindicated for contrast medium and anticoagulation drugs that cannot be pre-treated.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Christiana Hospital
Newark, Delaware, 19713
About this study
Official title: A Phase I Feasibility Study of the TAArget Thoracic Stent Graft for the Treatment of Aneurysms in the Descending Thoracic Aorta
Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.
Read the detailed description
- Subject is > 18 years of age.
- Females subjects must be either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and must have a negative serum pregnancy test at screening.
- Subject is a candidate for endovascular thoracic aortic repair.
- Subject has a TAA that meets one of the following criteria:
- Is diagnosed with a Fusiform Focal TAA >5cm, or
- Is diagnosed with a Fusiform Focal TAA that has a diameter < 5 cm and has exhibited rapid expansion, or
- Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
- Is diagnosed with a saccular TAA of any size.
- Conditions
- Thoracic Aortic Aneurysm
- Being tested
- Endovascular repair of TAA in the descending Thoracic Aorta
- Keywords
- TAA, Thoracic, Descending Thoracic Aorta, TAArget
- 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 repair of TAA in the descending Thoracic AortaDevice
Usage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta.
| Study group | Role | What they receive |
|---|---|---|
| TAArget Thoracic Stent Graft | Experimental | those treated with the investigational device Receives: Device: Endovascular repair of TAA in the descending Thoracic Aorta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who experience ≥ 1 major adverse events (MAE) related to the experimental device/procedure at early (30-day) and late (6-month) endovascular TAA repair as compared with the open surgical repair group.
Measured: 30 day and 6 month
The primary effectiveness endpoint of early (30-day) and late (6-month) endovascular TAA repair will be assessed by the proportion of subjects free from major device related events
Measured: 30 day and 6 months
Secondary outcomes (1)
• All cause mortality • Aneurysm related mortality compared to an open surgical control group • Major adverse events • Minor adverse events
Measured: 30 day and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic AneurysmStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke Vascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kartikeshwar Kasirajan, M.D., Principal investigator, Emory University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033214
- Sponsor's protocol ID
- LMV-TAA-P1-001
- Status last verified
- May 2015
- First submitted
- 14 Dec 2009
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Feasibility Study of the TAArget Thoracic Stent Graft for the Treatment of Aneurysms in the Descending Thoracic Aorta
- ClinicalTrials.gov ID
- NCT01033214
- Acronym / sponsor ID
- LMV-TAA-P1-001
- Conditions
- Thoracic Aortic Aneurysm
- Keywords
- TAA, Thoracic, Descending Thoracic Aorta, TAArget
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duke Vascular, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 16 Dec 2009 (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.
Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.
Detailed description
- Subject is > 18 years of age.
- Females subjects must be either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and must have a negative serum pregnancy test at screening.
- Subject is a candidate for endovascular thoracic aortic repair.
- Subject has a TAA that meets one of the following criteria:
- Is diagnosed with a Fusiform Focal TAA >5cm, or
- Is diagnosed with a Fusiform Focal TAA that has a diameter < 5 cm and has exhibited rapid expansion, or
- Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
- Is diagnosed with a saccular TAA of any size.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAArget Thoracic Stent Graft | Experimental | Device: Endovascular repair of TAA in the descending Thoracic Aortathose treated with the investigational device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is > 18 years of age. Female subjects are either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and have a negative serum pregnancy test at screening.
- Subject is a candidate for endovascular thoracic aortic repair.
- Is diagnosed with a Fusiform Focal TAA ≥5cm, or
- Is diagnosed with a Fusiform Focal TAA that has a diameter ≤ 5 cm and has exhibited rapid expansion, or
- Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
Key exclusion criteria (6 listed)
- Subject has a life expectancy < 2 years.
- Subject has a lesion that prevents safe delivery or expansion of the device.
- Subject has concomitant ascending aortic aneurysm.
- Subject has known allergies to any of the device materials.
- Subject has coagulopathy or bleeding disorders that cannot be pre-treated.
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 repair of TAA in the descending Thoracic AortaUsage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta. | Device | TAArget Thoracic Stent Graft |
Primary outcome
Proportion of subjects who experience ≥ 1 major adverse events (MAE) related to the experimental device/procedure at early (30-day) and late (6-month) endovascular TAA repair as compared with the open surgical repair group.
Time frame: 30 day and 6 month
The primary effectiveness endpoint of early (30-day) and late (6-month) endovascular TAA repair will be assessed by the proportion of subjects free from major device related events
Time frame: 30 day and 6 months
1 secondary outcome
• All cause mortality • Aneurysm related mortality compared to an open surgical control group • Major adverse events • Minor adverse events
Time frame: 30 day and 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
Related trials for Thoracic Aortic Aneurysm
Recruiting
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Recruiting
Triple Branched Stent Graft System for Aortic Arch Lesions
Aortic Arch Aneurysm, Aortic Arch Pseudoaneurysm
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.
Kartikeshwar Kasirajan, M.D. principal investigator
Emory University Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Endovascular repair of TAA in the descending Thoracic Aorta in people with Thoracic Aortic Aneurysm, run by Duke Vascular, Inc. at 2 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 9 inclusion and 6 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 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Proportion of subjects who experience ≥ 1 major adverse events (MAE) related to the experimental device/procedure at early (30-day) and late (6-month) endovascular TAA repair as compared with the open surgical repair group. (time frame: 30 day and 6 month). The study lists 2 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 20 May 2015.