Overview

This trial is active, not recruiting.

Condition abdominal aortic aneurysms
Treatment endurant stent graft system
Phase phase 3
Sponsor Medtronic Endovascular
Start date June 2008
End date September 2012
Trial size 194 participants
Trial identifier NCT00705718, Medtronic - 089

Summary

To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The Bifurcated arm includes subjects who have received a bifurcated device. The Endurant Stent Graft System Bifurcated device is administered to treat patients with an Abdominal Aortic Aneurysm.
endurant stent graft system Endovascular treatment of Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm Repair
(Experimental)
The AUI arm includes subjects who have received an AUI device. The Endurant Stent Graft System AUI device is administered to treat patients with an Abdominal Aortic Aneurysm.
endurant stent graft system Endovascular treatment of Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm Repair

Primary Outcomes

Measure
Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)
time frame: 30 days (Safety)
Major Adverse Events Within 30 Days of Index Procedure
time frame: 30 days
Primary Effectiveness Endpoint (Technical Success)
time frame: Intra-operatively
Primary Effectiveness Endpoint (Treatment Success)
time frame: 12 months

Secondary Outcomes

Measure
Secondary Endpoints - Safety Evaluation
time frame: 12 months
Secondary Endpoint - Effectiveness Evaluation
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Subject is ≥ 18 years old. 2. 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. 3. Subject is able and willing to comply with the protocol and undergo follow-up requirements. 4. 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 5. Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter 6. Subject meets all the protocol anatomical criteria* as demonstrated on contrast-enhanced CT or MRA 7. Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft 8. 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. 9. Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System. Exclusion Criteria: 1. Subject has a life expectancy < 1 year 2. Subject is participating in another investigational drug or device study 3. Subject requires emergent aneurysm treatment 4. Subject is a female of childbearing potential in whom pregnancy cannot be excluded. 5. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment. 6. Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.

Additional Information

Official title Endurant Stent Graft System US Clinical Study
Principal investigator Michel S Makaroun, MD
Description Prospective, two-arm, non-randomized, multicenter clinical study enrolling subjects treated with the bifurcated stent graft in one arm and subjects treated with the AUI in a second arm.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Medtronic Endovascular.