Aortic Aneurysm, Abdominal
Conditions
Keywords
Aortic Aneurysm, Aneurysm, Abdominal Aortic Aneurysm, Talent, Medtronic
Brief summary
The purpose of this study is to examine, through the endpoints established in this protocol, the long-term safety and effectiveness of the Talent Abdominal Stent Graft System, in a post-approval environment.
Detailed description
The Talent Abdominal Stent Graft System is a next-generation modular system for endovascular repair of Abdominal Aortic Aneurysm (AAA). The system was designed with the following enhancements: a suprarenal wire frame to provide migration resistance, and improved flexibility designed to treat difficult anatomies. Medtronic Vascular submitted a Pre-Market Application (PMA) to the Food and Drug Administration (FDA) on October 17, 2007, and received market approval for the Talent Abdominal Stent Graft System on April 15th, 2008. As a condition of approval, the FDA has requested a post-approval study. Medtronic has therefore designed a post-approval study, in collaboration with FDA, to document the performance of the Talent Abdominal Stent Graft System under market conditions.
Interventions
DEVICETalent Abdominal Stent Graft
The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement.
Sponsors
Medtronic Cardiovascular
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
* Subject must have an abdominal aortic aneurysm, with or without iliac involvement. * Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; * A proximal aortic neck length of ≥ 10mm; * Proximal aortic neck angulation ≤ 60°; * Distal iliac artery fixation length of ≥ 15mm; * An aortic neck diameter of 18-32mm and iliac artery diameters of 8-22mm; and * Vessel morphology suitable for endovascular repair.
Exclusion criteria
* Are less than 18 years of age * Are pregnant or lactating * Have a dominant patent inferior mesenteric artery and an occluded or stenotic celiac and/or superior mesenteric artery * Have aneurysmal involvement or occlusion (surgically performed or naturally occurring) of the bilateral internal iliac arteries * Have vessels and/or aneurysm dimensions that cannot accommodate the Talent Abdominal Stent Graft as per the indications in Section 3. * Have no distal vascular bed (one vessel lower extremity run-off required) * Have contraindications for use of contrast medium or anticoagulation drugs * Have an uncorrectable coagulopathy * Have an SVS/AAVS score greater than 2 * Have a mycotic aneurysm * Have circumferential mural thrombus in the proximal aortic neck * Have had a recent (within 3 months) myocardial infarction (MI), cerebral vascular accident (CVA), or major surgical intervention * Have traumatic aortic injury * Have leaking, pending rupture or ruptured aneurysms * Have pseudoaneurysms resulting from previous graft placement * Require a revision to previously placed endovascular stent grafts. * Have genetic connective tissue disease (e.g., Marfan's or Ehlers-Danlos' Syndromes) * Have concomitant thoracic aortic or thoracoabdominal aneurysms * Are patients with active systemic infections * Are patients who have a condition that threatens to infect the graft. * Are patients with sensitivities or allergies to the device materials. * Have access vessels (as determined by treating physician) that preclude safe insertion of the delivery system. NOTE: Iliac conduits may be used to ensure the safe insertion of the delivery system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Aneurysm-related Mortality (ARM) | 5 year Kaplan Meier (KM) | ARM is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should also be aneurysm related. All deaths were adjudicated by a Clinical Events Committee (CEC) to determine aneurysm, device and/or procedure relatedness. |
Countries
United States
Participant flow
Pre-assignment details
166 subjects were enrolled in the previous cohort study (NCT # is not available). 94 subjects were enrolled into the Vitality study. When these two cohorts are combined it totals 260. The Vitality study collected information on its 94 enrolled subjects, but for study analysis both cohorts were combined.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU.\>
\> Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement. | 260 |
| Total | 260 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 73.7 years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 254 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 241 Participants |
| Region of Enrollment United States | 260 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 227 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 94 | 112 / 166 |
| serious Total, serious adverse events | 31 / 94 | 99 / 166 |
Outcome results
Primary
Freedom From Aneurysm-related Mortality (ARM)
ARM is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should also be aneurysm related. All deaths were adjudicated by a Clinical Events Committee (CEC) to determine aneurysm, device and/or procedure relatedness.
Time frame: 5 year Kaplan Meier (KM)
Population: All enrolled subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Freedom From Aneurysm-related Mortality (ARM) | .97 Proportion of participants |