N/A
N=194
Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System
Abdominal Aortic Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT00705718 ↗Enrolled (actual)
194
Serious AEs
45.9%
Results posted
Mar 2014
Primary outcome: Primary: Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure) — 88.6; 96.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endurant Stent Graft System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiovascular
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure) |
88.6; 96.0 | — |
| PRIMARY Major Adverse Events Within 30 Days of Index Procedure |
11.4; 4.0; 2.3; 0; 6.8; 0.7 | — |
| PRIMARY Primary Effectiveness Endpoint (Technical Success) |
43; 118 | — |
| PRIMARY Primary Effectiveness Endpoint (Treatment Success) |
35; 118; 0; 0; 0; 1 | — |
| SECONDARY Secondary Endpoints - Safety Evaluation |
100; 100; 97.7; 100; 86.4; 95.7 | — |
| SECONDARY Secondary Endpoint - Effectiveness Evaluation |
0.0; 0.0; 100.0; 97.6; 14.3; 16.1 | — |
Summary
To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.
Eligibility Criteria
Inclusion Criteria
- Subject is ≥ 18 years old.
- Subject (or Subject's legal representative) understands and voluntarily has signed and dated an Informed Consent document approved by the Sponsor and by the Institutional Review Board.
- Subject is able and willing to comply with the protocol and undergo follow-up requirements.
- Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, III, or IV
- Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter
- Subject meets all the protocol anatomical criteria* as demonstrated on contrast-enhanced CT or MRA
- Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft
- Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral artery, or can tolerate a vascular conduit that allows introduction of the device.
- Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System.
Exclusion Criteria
- Subject has a life expectancy < 1 year
- Subject is participating in another investigational drug or device study
- Subject requires emergent aneurysm treatment
- Subject is a female of childbearing potential in whom pregnancy cannot be excluded.
- Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
- Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.
Data sourced from ClinicalTrials.gov (NCT00705718). 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.