N/A
N=401
Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
Abdominal Aortic Aneurysm · Iliac Aneurysm · Internal Iliac Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT00583414 ↗Enrolled (actual)
401
Serious AEs
2.2%
Results posted
Jan 2019
Primary outcome: Primary: Freedom From Aneurysm Rupture — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endovascular Aneurysm Repair (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Aneurysm Rupture |
— | — |
Summary
The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00583414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.