ABDOMINAL AORTIC ANEURYSMS
Conditions
Keywords
AAA, Aneurysm, AneuRx, Talent
Brief summary
The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.
Interventions
DEVICEAneuRx AAA stent graft / Talent AAA stent graft
Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Sponsors
The Cleveland Clinic
Medtronic Cardiovascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 40 to 90 years of age * Meet all indications for use as stated in the Medtronic Vascular AAA Endograft Instructions for Use * Maximum aneurysm diameter of 4-5cm * If female patient with child bearing potential, must have a documented negative pregnancy test within seven(7)days prior to inclusion * Patient is willing and able to comply with the specified follow-up evaluation * Life expectancy at least 3 years
Exclusion criteria
* Meet any of the Contraindications stated in the Medtronic Vascular AAA Endograft instructions for Use * Known co-existing condition with a life expectancy of less than 3 years * Major surgical or interventional procedure (vascular and/or non-vascular)within 30 days prior to study enrollment * Subjects enrolled in another clinical trial or anticipated to be included into a trial, which may interfere with this study, or subjects already enrolled in this trial before. * Planned conduit procedure for introduction of endograft
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects That Experienced Rupture or Aneurysm Related Death | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aneurysm Growth >0.5 cm | 1 year | After repair, AAA enlargement by \>0.5cm |
| Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up | study termination | secondary interventions in those that had successful delivery and deployment by treatment group randomized to. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surveillance Subjects were assigned to serial ultrasound surveillance | 362 |
| Early Endovascular Repair AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm | 366 |
| Total | 728 |
Baseline characteristics
| Characteristic | Surveillance | Early Endovascular Repair | Total |
|---|---|---|---|
| Age, Continuous | 70.47 years STANDARD_DEVIATION 7.67 | 70.46 years STANDARD_DEVIATION 7.8 | 70.46 years STANDARD_DEVIATION 7.74 |
| Baseline AAA size | 4.45 cm STANDARD_DEVIATION 0.27 | 4.45 cm STANDARD_DEVIATION 0.27 | 4.45 cm STANDARD_DEVIATION 0.27 |
| Race/Ethnicity, Customized Hispanic ethnicity | 7 Participants | 7 Participants | 14 Participants |
| Race/Ethnicity, Customized White race | 343 Participants | 340 Participants | 683 Participants |
| Region of Enrollment United States | 362 Participants | 366 Participants | 728 Participants |
| Sex: Female, Male Female | 56 Participants | 41 Participants | 97 Participants |
| Sex: Female, Male Male | 306 Participants | 325 Participants | 631 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 15 / 362 | 15 / 366 |
| other Total, other adverse events | 21 / 362 | 40 / 366 |
| serious Total, serious adverse events | 208 / 362 | 166 / 366 |
Outcome results
Primary
Number of Subjects That Experienced Rupture or Aneurysm Related Death
Time frame: 3 years
Population: Study was terminated before all subjects enrolled and completed follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surveillance | Number of Subjects That Experienced Rupture or Aneurysm Related Death | 2 Participants |
| Early Endovascular Repair | Number of Subjects That Experienced Rupture or Aneurysm Related Death | 2 Participants |
Secondary
Aneurysm Growth >0.5 cm
After repair, AAA enlargement by \>0.5cm
Time frame: 1 year
Population: Study was terminated before all subjects enrolled and completed follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surveillance | Aneurysm Growth >0.5 cm | 35 Participants |
| Early Endovascular Repair | Aneurysm Growth >0.5 cm | 15 Participants |
Secondary
Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up
secondary interventions in those that had successful delivery and deployment by treatment group randomized to.
Time frame: study termination
Population: Study was terminated before all subjects enrolled and completed follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surveillance | Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up | 5 Participants |
| Early Endovascular Repair | Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up | 12 Participants |