Abdominal Aortic Aneurysms
Conditions
Keywords
AAA
Brief 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. 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.
Interventions
DEVICETalent Endoluminal Spring Graft System
Endovascular repair for patients with AAA who meet the inclusion criteria for the study
Sponsors
Rodney A. White, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Exclusion of Abdominal Aortic Aneurysm | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Device Delivery and Deployment | From the date of treatment assessed up to 5 years post treatment. | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | There Are no Study Arms. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 44 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 74.64 years STANDARD_DEVIATION 3.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Region of Enrollment United States | 49 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 19 / 49 |
| other Total, other adverse events | 4 / 49 |
| serious Total, serious adverse events | 29 / 49 |
Outcome results
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).
Time frame: From the date of treatment assessed up to 5 years post treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Number of Successful Exclusion of Abdominal Aortic Aneurysms | Number of Participants With Successful Exclusion of Abdominal Aortic Aneurysm | 49 participants' AAA |
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.
Time frame: From the date of treatment assessed up to 5 years post treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Number of Successful Exclusion of Abdominal Aortic Aneurysms | Number of Participants With Successful Device Delivery and Deployment | 49 Participants |