Abdominal Aortic AneurysmsNCT00695253
Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA)
A study testing Talent Endoluminal Spring Graft System in people with Abdominal Aortic Aneurysms, run by Rodney A. White, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the Talent Endoluminal Spring Graft System, an investigational device, to treat abdominal aortic aneurysms (AAA). The treatment population will include patients with an abdominal aortic aneurysm who meet the inclusion/exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- Talent Endoluminal Spring Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Mar 2013
- 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 must fulfill all of the following criteria.
- Subject is > 18 years of age.
- Subject is not pregnant, and, if female and of child-bearing potential, is practicing contraception.
- Subject has documented evidence of at least one patent internal iliac artery.
- Subject has an AAA that is dilated to > 4 cm in diameter.
- Subject has a proximal AAA neck (distance between the top of the aneurysm and the renal arteries) > 5 mm.
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- Subject has a proximal aortic neck diameter > 14 mm and < 32 mm.
- Subject has an angle between the suprarenal aorta and the aneurysm <60o.
- Subject has renal arteries > 9 cm from the aortic bifurcation.
- Subject has proximal and distal iliac neck diameters > 8 mm and < 18 mm to accommodate stock devices. For those subjects whose proximal and distal iliac diameters are > 18 mm, custom devices with a variation in fixation diameters will be ordered from the manufacturer.
- Subject has a distal iliac neck length > 15 mm.
- Subject has signed informed consent.
- Subject will be available for follow-up for 12 months after the procedure.
Who cannot join
- Subjects who fulfill any of the following criteria may not participate in this study.
- Subject has patent internal iliac arteries that require graft extension to the external iliac arteries.
- Subject has one or more patent subrenal arteries with potential retrograde flow after stent-grafting.
- Subject has a dominant patent inferior mesenteric artery and an occluded or stenotic celiac and superior mesenteric artery.
- Subject has an aneurysm involving both internal iliac arteries.
- Subject has a lesion that cannot be crossed with a guide wire.
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- Subject whose arterial access site cannot accommodate the delivery catheter.
- Subject has no distal vascular bed.
- Subject has systemic infection, or is suspected of having systemic infection.
- Subject has contraindications for use of contrast medium or anticoagulation drugs.
- Subject has received a previous stent in the subrenal aorta.
- Subject has an untreatable bleeding diathesis.
- Subject is in a hypercoagulable state.
Trial locations and contacts
1 site in 1 country.
United States1 site
LAC Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With AAA
The purpose of this study is to evaluate the safety and effectiveness of the Talent Endoluminal Spring Graft System, an investigational device, to treat abdominal aortic aneurysms (AAA). The treatment population will include patients with an abdominal aortic aneurysm who meet the inclusion/exclusion criteria. All patients in the treatment population will undergo post-procedure follow-up evaluations at one (1), six (6), and 12 months and annually thereafter up to five (5) years post-procedure.
Read the detailed description
Endovascular aneurysm repair (EVAR) offers certain advantages as compared to surgical repair of an abdominal aortic aneurysm. Known benefits associated with EVAR, as described in scientific literature, include minimally invasive procedure, shorter ICU and hospital stay, reduced blood loss, more rapid recovery, and reduced need for general anesthesia. Potential benefits that may be associated with use of the Talent device include reduced occurrence of endoleaks, therefore reduced subsequent re-interventions. The risks/complications known to occur to all patients undergoing AAA repair may include anesthetic complications, (e.g., aspiration), aneurysm enlargement, rupture, perforation or dissection, bleeding, arterial or venous thrombosis and/or pseudoaneurysm, arteriovenous fistula, hematoma or coagulopathy, bowel complications, cardiac complications, (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension), embolization (micro and macro) with transient or permanent ischemia or infarction, genitourinary complications, infection, neurologic complications, occlusion of device or native vessel, pulmonary/respiratory complications and renal complications.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- Talent Endoluminal Spring Graft System
- Keywords
- AAA
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talent Endoluminal Spring Graft SystemDevice
Endovascular repair for patients with AAA who meet the inclusion criteria for the study
| Study group | Role | What they receive |
|---|---|---|
| Talent Endoluminal Spring Graft System | Other | Single Arm study of the endoluminal treatment of Abdominal Aortic Aneurysms using the Talent Endoluminal Spring Graft System Receives: Device: Talent Endoluminal Spring Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Exclusion of Abdominal Aortic Aneurysm
The safety and effectiveness of the endoluminal device was determined by the number participants with successful exclusion of the abdominal aortic aneurysm (AAA).
Measured: From the date of treatment assessed up to 5 years post treatment.
Secondary outcomes (1)
Number of Participants With Successful Device Delivery and Deployment
Delivery success is defined as the successful access of the vessel and insertion of the delivery sheath to the treatment site. Deployment success is defined as the advancement through the vasculature to the desired location and full deployment within 0.5 cm of the intended location. Aneurysm exclusion is achieved when there is no evidence of blood flow around or through the stent graft into the aneurysm or where there is an absence of contrast within the aneurysm sac.
Measured: From the date of treatment assessed up to 5 years post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startApr 2002
- Primary completionMar 2013
- Study completionMar 2013
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 Abdominal 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
- 49 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
- NCT00695253
- Sponsor's protocol ID
- 10807-01
- Status last verified
- Feb 2023
- First submitted
- 28 Dec 2007
- Last updated
- 15 Feb 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 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With AAA
- ClinicalTrials.gov ID
- NCT00695253
- Acronym / sponsor ID
- 10807-01
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- AAA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Rodney A. White, M.D.University, hospital or other
- Study start
- Apr 2002
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Posted 29 Sep 2021
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 safety and effectiveness of the Talent Endoluminal Spring Graft System, an investigational device, to treat abdominal aortic aneurysms (AAA). The treatment population will include patients with an abdominal aortic aneurysm who meet the inclusion/exclusion criteria. All patients in the treatment population will undergo post-procedure follow-up evaluations at one (1), six (6), and 12 months and annually thereafter up to five (5) years post-procedure.
Detailed description
Endovascular aneurysm repair (EVAR) offers certain advantages as compared to surgical repair of an abdominal aortic aneurysm. Known benefits associated with EVAR, as described in scientific literature, include minimally invasive procedure, shorter ICU and hospital stay, reduced blood loss, more rapid recovery, and reduced need for general anesthesia. Potential benefits that may be associated with use of the Talent device include reduced occurrence of endoleaks, therefore reduced subsequent re-interventions. The risks/complications known to occur to all patients undergoing AAA repair may include anesthetic complications, (e.g., aspiration), aneurysm enlargement, rupture, perforation or dissection, bleeding, arterial or venous thrombosis and/or pseudoaneurysm, arteriovenous fistula, hematoma or coagulopathy, bowel complications, cardiac complications, (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension), embolization (micro and macro) with transient or permanent ischemia or infarction, genitourinary complications, infection, neurologic complications, occlusion of device or native vessel, pulmonary/respiratory complications and renal complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Talent Endoluminal Spring Graft System | Other | Device: Talent Endoluminal Spring Graft SystemSingle Arm study of the endoluminal treatment of Abdominal Aortic Aneurysms using the Talent Endoluminal Spring Graft System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects who participate in this study must fulfill all of the following criteria.
- Subject is > 18 years of age.
- Subject is not pregnant, and, if female and of child-bearing potential, is practicing contraception.
- Subject has documented evidence of at least one patent internal iliac artery.
- Subject has an AAA that is dilated to > 4 cm in diameter.
Key exclusion criteria (13 listed)
- Subjects who fulfill any of the following criteria may not participate in this study.
- Subject has patent internal iliac arteries that require graft extension to the external iliac arteries.
- Subject has one or more patent subrenal arteries with potential retrograde flow after stent-grafting.
- Subject has a dominant patent inferior mesenteric artery and an occluded or stenotic celiac and superior mesenteric artery.
- Subject has an aneurysm involving both internal iliac arteries.
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 Endoluminal Spring Graft SystemEndovascular repair for patients with AAA who meet the inclusion criteria for the study | Device | Talent Endoluminal Spring Graft System |
Primary outcome
Number of Participants With Successful Exclusion of Abdominal Aortic Aneurysm
Time frame: From the date of treatment assessed up to 5 years post treatment.
The safety and effectiveness of the endoluminal device was determined by the number participants with successful exclusion of the abdominal aortic aneurysm (AAA).
1 secondary outcome
Number of Participants With Successful Device Delivery and Deployment
Time frame: From the date of treatment assessed up to 5 years post treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 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 Talent Endoluminal Spring Graft System in people with Abdominal Aortic Aneurysms, 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 13 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 15 Feb 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 29 Sep 2021). 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 Exclusion of Abdominal Aortic Aneurysm (time frame: From the date of treatment assessed up to 5 years post treatment.). 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 15 Feb 2023.