Abdominal Aortic Aneurysm, Iliac Aneurysm, Internal Iliac Aneurysm
Conditions
Brief summary
The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.
Detailed description
This study is a prospective, non-randomized evaluation of endovascular aneurysm repair in high-risk patients. The purpose of this study is to determine whether this endovascular prosthesis is safe and effective for the intended use of treating AAA/iliac aneurysm in patients who are at high risk for standard aneurysm surgical repair. Up to 400 patients will be enrolled at the Cleveland clinic Foundation. Baseline procedures may include angiogram, intravascular ultrasound, CT scan, physical exam, blood work and ankle-brachial index. The endovascular prosthesis is placed in the operating room under regional or general anesthesia and the procedure length is approximately 2-3 hours. Follow up evaluations will be done at 1 month, 6 months (if clinically necessary), 12 months and yearly, and may include a physical exam, CT scan, KUB, ultrasound, blood work, and an ankle-brachial index.
Interventions
Endovascular exclusion of aneurysm
Sponsors
The Cleveland Clinic
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
* The aneurysm is \>/= 5 cm or larger, or with a high risk of rupture due to its shape, history of growth, symptoms, or the presence of a large (\>2 cm) iliac aneurysm * Anticipated mortality greater than 10 percent with conventional surgery * Life expectancy greater than 2 years * Suitable arterial anatomy * Absence of systemic disease or allergy that precludes an endovascular repair * Capable of giving informed consent and willingness to comply with the follow-up schedule
Exclusion criteria
* Pregnancy * History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately * Allergy to stainless steel or polyester * Unwilling to comply with the follow-up schedule * Serious or systemic groin infection * Coagulopathy, other than coumadin therapy * Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Aneurysm Rupture | 2 years | Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endovascular Aneurysm Repair Investigational stent-graft implant to exclude aneurysm
Endovascular Aneurysm Repair: Endovascular exclusion of aneurysm | 401 |
| Total | 401 |
Baseline characteristics
| Characteristic | Endovascular Aneurysm Repair | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 345 Participants | — |
| Age, Categorical Between 18 and 65 years | 56 Participants | — |
| Presence of AAA or Iliac Aneurysm | 401 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 43 Participants | — |
| Sex: Female, Male Male | 358 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 292 / 401 |
| other Total, other adverse events | 9 / 401 |
| serious Total, serious adverse events | 9 / 401 |
Outcome results
Primary
Freedom From Aneurysm Rupture
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Aneurysm Repair | Freedom From Aneurysm Rupture | 0 Participants |