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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Talent Endoluminal Spring Graft System | Other | Single Arm study of the endoluminal treatment of Abdominal Aortic Aneurysms using the Talent Endoluminal Spring Graft System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talent Endoluminal Spring Graft System | Device | Endovascular repair for patients with AAA who meet the inclusion criteria for the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From the date of treatment assessed up to 5 years post treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodney A. White, M.D. | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAC Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
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About 75 patients were screened for eligibility for enrollment in the study based on the inclusion/exclusion criteria. Participants were selected over a 7 year period between 2002 and 2008 and were made up of patients in the hospital, clinic patients as well as those referred from other clinics and facilities.
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| ID | Title | Description |
|---|---|---|
| FG000 | Talent Endoluminal Spring Graft System | All participants who were diagnosed with abdominal aortic aneurysms and who were eligible for enrollment as defined by the inclusion/exclusion criteria were screened. These patients included both high and low risk patients who signed a consent to participate in this Physician-sponsored IDE for the endoluminal treatment of their abdominal aneurysm using the Medtronic/Talent Stent Graft: Stent-graft for Abdominal Aortic Aneurysms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | There Are no Study Arms. | All participants who were diagnosed with abdominal aortic aneurysms and who were eligible for enrollment as defined by the inclusion/exclusion criteria were screened. These patients included both high and low risk patients who signed a consent to participate in this Physician-sponsored IDE for the endoluminal treatment of their abdominal aneurysm using the Medtronic/Talent Stent Graft: Stent-graft for Abdominal Aortic Aneurysms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | participants' AAA | From the date of treatment assessed up to 5 years post treatment. |
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From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Talent Endoluminal Spring Stent Graft System | Endoluminal treatment of abdominal aortic aneurysms using the Medtronic/Talent Stent Graft: Stent-graft for all patients with abdominal aortic lesions who signed consent into this Physician - Sponsored IDE. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rodney A. White, M. D. | Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | 310 963-5230 | rawhite@ucla.edu |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| From the date of treatment assessed up to 5 years post treatment. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Posted | Count of Participants | Participants | From the date of treatment assessed up to 5 years post treatment. |
|
|
|
| 19 |
| 49 |
| 29 |
| 49 |
| 4 |
| 49 |
| Vessel Injury | Vascular disorders | Systematic Assessment |
|
| Lung Cancer | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
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| Endoleak | Vascular disorders | Systematic Assessment |
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| Ruptured AAA | Vascular disorders | Systematic Assessment | 6 months post procedure |
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| Ruptured TAA | Vascular disorders | Systematic Assessment | 18 months post procedure |
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| Renal Cancer | Renal and urinary disorders | Systematic Assessment |
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| Prostate cancer | Reproductive system and breast disorders | Systematic Assessment |
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| Stent Graft migration | Vascular disorders | Systematic Assessment | At > 2 years post procedure |
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| Stent Graft occlusion | Vascular disorders | Systematic Assessment | At > 1 year post procedure |
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| Peripheral Vascular Disease | Vascular disorders | Systematic Assessment |
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| D001018 |
| Aortic Diseases |