Thoracic Aortic AneurysmsNCT00597870
Physician-Sponsored IDE for the Talent Endoluminal Stent Graft System for the Treatment of Thoracic Lesions
A study testing Endoluminal treament of thoracic lesions in people with Thoracic Aortic Aneurysms and Thoracic Transections, run by Rodney A. White, M.D. at 1 site in United States.
Trial summary
The primary objective of this trial is to determine whether the Talent Thoracic Stent Graft, an investigational device, is a safe and effective method of treating thoracic aortic aneurysms (abnormal ballooning of the vessel wall) and other thoracic lesions (dissections, transections, pseudoaneurysms, penetrating… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysms, Thoracic Transections, Intramural Hematoma
- What is being tested?
- Endoluminal treament of thoracic lesions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Jan 2021
- 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
- Subjects who participate in this study as study patients must fulfill the following criteria:
- Subject is > 18 years of age.
- Subject is not pregnant or lactating. Females of child-bearing potential must practice a reliable method of contraception.
- Subject is diagnosed with one of the following conditions of the descending thoracic aorta. All conditions must be verified by diagnostic imaging [ultrasonography, computed tomography (CT), magnetic resonance imaging (MRI) or angiography].
- A true (i.e., atherosclerotic) supraceliac aneurysm (fusiform or saccular type) with or without a co-existing aortic dissection or penetrating aortic ulcer
- Aortic dissection of DeBakey Type I or II (Stanford A, proximal) in the absence of an aneurysm; OR
Show all 15Show fewer
- Penetrating aortic ulcer in the absence of an aneurysm; OR
- Traumatic transection; OR
- Pseudoaneurysm - traumatic or degenerative (i.e., one that does not involve all layers of the vessel and is not atherosclerotic in origin).
- Subject's anatomy is suitable for placement of the Medtronic/Talent Stent-Graft, with a distinct proximal aneurysm neck of 10 mm or more in length and a distal aneurysm neck of at least 10 mm.
- Subject has a TAA that is dilated to > 5 cm in diameter, > 1.5 times the diameter of the adjacent native/non-aneurysmal aorta, or is symptomatic.
- Subject has a proximal and distal aortic neck diameter > 18 mm and < 42 mm.
- Subject has an arterial access site, either peripherally or via infrarenal abdominal aorta that is adequate for introduction of the stent-graft delivery system.
- Subject is competent to give informed consent.
- Subject will be available for the periodic follow-up (surveillance) after the procedure.
Who cannot join
- Subjects who would participate as study subjects and who fulfill any of the following criteria may not participate in this study:
- Subject has TAA with less than 10 mm proximal fixation length.
- Subject has an aneurysm that would require exclusion by the stent-graft of the segment of the aorta that gives rise to dominant spinal cord/intercostal arteries.
- Subject has a lesion that prevents delivery or expansion of the device.
- Subject has systemic infection, or is suspected of having systemic infection.
- Subject has a known mycotic aneurysm.
- Subject is not available or is not willing to come back for periodic follow-up (surveillance) after the procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
LAC Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
The primary objective of this trial is to determine whether the Talent Thoracic Stent Graft, an investigational device, is a safe and effective method of treating thoracic aortic aneurysms (abnormal ballooning of the vessel wall) and other thoracic lesions (dissections, transections, pseudoaneurysms, penetrating ulcers, etc.). The endovascular method is a substitute for the major operation that is performed to treat the lesions.
Read the detailed description
The endovascular method consists of the insertion of catheters (vinyl tubes) into both groin arteries. These catheters then allow positioning of artificial tubes or stent graft(s) into the diseased blood vessel without the need for major surgery which involves opening the chest. The blood vessel problem (thoracic aortic aneurysm/lesion) will be treated using an artificial bypass tube (stent graft) that will be placed inside the diseased artery. The stent graft(s) that will be used are made of polyester graft fabric sewn to a self-expanding nickel-titanium (Nitinol) wire frame and is manufactured by Medtronic AVE, Santa Rosa California.
Aneurysms/lesions can be located in any position along the length of the aorta. This study evaluates only aneurysms/lesions that occur in the descending part of the thoracic aorta as it traverses the chest and enters the abdominal cavity. The risk of thoracic aneurysms/lesions is that they rupture without warning. The risk of rupture increases as the aneurysm size increases. Following rupture, almost all patients expire within the first 24 hours. For this reason treatment of thoracic aneurysms/lesions is recommended by conventional surgical means if the patient is a candidate for an operation. The conventional operation involves occluding the aorta and replacing the aneurysm with a cloth tube that is sewn to replace the diseased part of the aorta. The major surgery and occlusion of the aorta that is part of the conventional surgery is directly related to several complications that have been reported in the literature. In addition, many patients are too ill for conventional surgery due to concomitant illnesses.
After the procedure, the patient will be followed at regular intervals (pre-discharge, 1 month, 6 months, 12 months and every year thereafter for life) as part of the evaluation of the experimental treatment. During this time, the patient will have several tests performed to evaluate the function of the repair. The tests will include clinical examination, x-rays of the chest and spiral CT scan. The experimental part is the placement of the TALENT Stent-Graft System using the catheter (endovascular) methods. The risk of the experimental catheter bypasses is that the procedure may not be successful. In most cases, this would require a standard operation to repair the problem. Sometimes there are other risks such as injury to the vessels. Small pieces of diseased arteries may be dislodged which may require removal. Bleeding may occur from introduction sites, and rarely, infection may develop. If a catheter bypass is unsuccessful, there can be added discomfort because the procedure may last longer.
The benefits of the procedure are that the patient might avoid some of of the pain and discomfort associated with standard operations. Major surgery is avoided and hospital stay may be much shorter. Patients may be able to return to usual daily activities sooner. In addition, patients who are too high risk for conventional surgical treatment can have their aneurysm treated using the endovascular graft if their anatomy is appropriate
- Conditions
- Thoracic Aortic Aneurysms, Thoracic Transections, Intramural Hematoma, Pseudoaneurysm, Thoracic Aortic Dissection
- Being tested
- Endoluminal treament of thoracic lesions
- Keywords
- TAA
- Medical subject headings
- Aortic Aneurysm, Thoracic, Aneurysm, False, Dissection, Thoracic Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoluminal treament of thoracic lesionsDevice
Endoluminal treament of thoracic lesions with a thoracic stent-graft
| Study group | Role | What they receive |
|---|---|---|
| Treatment of Thoracic Lesions | Experimental | Endoluminal treatment of thoracic lesions Receives: Device: Endoluminal treament of thoracic lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Endoluminal Treatment of Thoracic Lesion
Evaluate the number of patients who had successful treatment of their thoracic lesion using the Medtronic Talent Endoluminal Stent Graft..
Measured: Throughout study completion, an average of 1 year
Secondary outcomes (1)
Number of Participants With Successful Device Delivery and Deployment
Evaluate the number of patients where the thoracic device was successfully delivered and deployed within the patients' thoracic lesion.
Measured: Throughout study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startMay 2002
- Primary completionJan 2021
- Study completionJan 2021
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rodney A. White, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rodney A. White, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Rodney A. White, M.D., Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597870
- Sponsor's protocol ID
- 10837-01
- Status last verified
- Jun 2023
- First submitted
- 28 Dec 2007
- Last updated
- 14 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician-Sponsored IDE for the Talent Endoluminal Stent Graft System for the Treatment of Thoracic Lesions
- ClinicalTrials.gov ID
- NCT00597870
- Acronym / sponsor ID
- 10837-01
- Conditions
- Thoracic Aortic Aneurysms, Thoracic Transections, Intramural Hematoma, Pseudoaneurysm, Thoracic Aortic Dissection
- Keywords
- TAA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Rodney A. White, M.D.University, hospital or other
- Study start
- May 2002
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Posted 14 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to determine whether the Talent Thoracic Stent Graft, an investigational device, is a safe and effective method of treating thoracic aortic aneurysms (abnormal ballooning of the vessel wall) and other thoracic lesions (dissections, transections, pseudoaneurysms, penetrating ulcers, etc.). The endovascular method is a substitute for the major operation that is performed to treat the lesions.
Detailed description
The endovascular method consists of the insertion of catheters (vinyl tubes) into both groin arteries. These catheters then allow positioning of artificial tubes or stent graft(s) into the diseased blood vessel without the need for major surgery which involves opening the chest. The blood vessel problem (thoracic aortic aneurysm/lesion) will be treated using an artificial bypass tube (stent graft) that will be placed inside the diseased artery. The stent graft(s) that will be used are made of polyester graft fabric sewn to a self-expanding nickel-titanium (Nitinol) wire frame and is manufactured by Medtronic AVE, Santa Rosa California.
Aneurysms/lesions can be located in any position along the length of the aorta. This study evaluates only aneurysms/lesions that occur in the descending part of the thoracic aorta as it traverses the chest and enters the abdominal cavity. The risk of thoracic aneurysms/lesions is that they rupture without warning. The risk of rupture increases as the aneurysm size increases. Following rupture, almost all patients expire within the first 24 hours. For this reason treatment of thoracic aneurysms/lesions is recommended by conventional surgical means if the patient is a candidate for an operation. The conventional operation involves occluding the aorta and replacing the aneurysm with a cloth tube that is sewn to replace the diseased part of the aorta. The major surgery and occlusion of the aorta that is part of the conventional surgery is directly related to several complications that have been reported in the literature. In addition, many patients are too ill for conventional surgery due to concomitant illnesses.
After the procedure, the patient will be followed at regular intervals (pre-discharge, 1 month, 6 months, 12 months and every year thereafter for life) as part of the evaluation of the experimental treatment. During this time, the patient will have several tests performed to evaluate the function of the repair. The tests will include clinical examination, x-rays of the chest and spiral CT scan. The experimental part is the placement of the TALENT Stent-Graft System using the catheter (endovascular) methods. The risk of the experimental catheter bypasses is that the procedure may not be successful. In most cases, this would require a standard operation to repair the problem. Sometimes there are other risks such as injury to the vessels. Small pieces of diseased arteries may be dislodged which may require removal. Bleeding may occur from introduction sites, and rarely, infection may develop. If a catheter bypass is unsuccessful, there can be added discomfort because the procedure may last longer.
The benefits of the procedure are that the patient might avoid some of of the pain and discomfort associated with standard operations. Major surgery is avoided and hospital stay may be much shorter. Patients may be able to return to usual daily activities sooner. In addition, patients who are too high risk for conventional surgical treatment can have their aneurysm treated using the endovascular graft if their anatomy is appropriate
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of Thoracic Lesions | Experimental | Device: Endoluminal treament of thoracic lesionsEndoluminal treatment of thoracic lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects who participate in this study as study patients must fulfill the following criteria:
- Subject is > 18 years of age.
- Subject is not pregnant or lactating. Females of child-bearing potential must practice a reliable method of contraception.
- Subject is diagnosed with one of the following conditions of the descending thoracic aorta. All conditions must be verified by diagnostic imaging [ultrasonography, computed tomography (CT), magnetic resonance imaging (MRI) or angiography].
- Subject's anatomy is suitable for placement of the Medtronic/Talent Stent-Graft, with a distinct proximal aneurysm neck of 10 mm or more in length and a distal aneurysm neck of at least 10 mm.
Key exclusion criteria (7 listed)
- Subjects who would participate as study subjects and who fulfill any of the following criteria may not participate in this study:
- Subject has TAA with less than 10 mm proximal fixation length.
- Subject has an aneurysm that would require exclusion by the stent-graft of the segment of the aorta that gives rise to dominant spinal cord/intercostal arteries.
- Subject has a lesion that prevents delivery or expansion of the device.
- Subject has systemic infection, or is suspected of having systemic infection.
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 |
|---|---|---|
| Endoluminal treament of thoracic lesionsEndoluminal treament of thoracic lesions with a thoracic stent-graft | Device | Treatment of Thoracic Lesions |
Primary outcome
Number of Participants With Successful Endoluminal Treatment of Thoracic Lesion
Time frame: Throughout study completion, an average of 1 year
Evaluate the number of patients who had successful treatment of their thoracic lesion using the Medtronic Talent Endoluminal Stent Graft..
1 secondary outcome
Number of Participants With Successful Device Delivery and Deployment
Time frame: Throughout study completion, an average of 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Rodney A. White, M.D. principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoluminal treament of thoracic lesions in people with Thoracic Aortic Aneurysms and Thoracic Transections, run by Rodney A. White, M.D. 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 15 inclusion and 7 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 14 Sep 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2023). 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?
Number of Participants With Successful Endoluminal Treatment of Thoracic Lesion (time frame: Throughout study completion, an average of 1 year). 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 14 Sep 2023.