NCT01346943UnknownPhase 1
The Altura AAA Endograft Safety and Feasibility Study For Exclusion of Abdominal Aortic Aneurysms
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Altura Medical Inc.
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- The rate of major adverse events.
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety of deploying and implanting the Altura Abdominal Aortic Aneurysm (AAA) Endograft in the treatment of abdominal aortic aneurysms in subjects who are candidates for open surgical aneurysm repair.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older.
- •Subject or subject's legal representative understands and has signed an informed consent.
- •Infrarenal aneurysmal neck diameter between 18 and 28mm, inclusive.
- •Abdominal aneurysm neck angulation < 45 degrees.
- •Infrarenal non-aneurysmal neck >/= 15mm in length.
- •Abdominal aneurysm >4.5cm and growth >1.0 cm/yr.
- •Limited iliac artery tortuosity.
- •Iliac artery fixation length of >/= 15mm.
- •Iliac artery diameter between 8 and 19 mm, inclusive.
- •Iliac artery diameter accessible by a 14 Fr introducer.
- •Subject is a candidate for open surgical repair of abdominal aortic aneurysm.
- •Patent iliac or femoral arteries access vessels, size and morphology to allow endovascular access of 14 Fr introducer sheaths and catheters.
- •Subject has > one year life expectancy.
- •Subject is not placed at additional risk while waiting for additional imaging necessary for vascular treatment.
- •Subject is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive.
- •Subject is able and willing to comply with 30 day, six (6) month, one (1) year and 2 (two) year follow-up.
Exclusion Criteria
- •Subject has an acutely ruptured or leaking or emergent aneurysm.
- •Subject has a dissecting aneurysm.
- •Subject has a mycotic or infected aneurysm.
- •Subject has current vascular injury due to trauma.
- •Subject's aneurysm is thoracic or suprarenal.
- •Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
- •Subject has thrombus, calcification and/or plaque that may compromise sealing
- •Subject has had a myocardial infarction within six (6) months prior to enrollment.
- •Subject has current angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia, or valvular disease.
- •Subject has undergone other major surgery within the 30 days prior to enrollment.
- •Subject is pregnant or nursing.
- •Known allergy to nitinol or polyester or contrast material that cannot be pretreated.
- •Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
- •Subject has connective tissue disease (e.g., Marfan's syndrome).
- •Subject has a bleeding disorder or anemia defined as hemoglobin < 9.0 mg/dL.
- •Subject is hypercoagulable.
- •Subject is on dialysis or has compromised renal function as reflected by a serum creatinine >2.2 mg/dL.
- •Subject has compromised hepatic function as measured by SGPT (ALT) > three (3) times the upper limit of normal.
- •Subject has active systemic infection.
- •Subject is participating in another research study involving an investigational agent for the treatment of AAA.
- •Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment.
Arms & Interventions
AAA Stent Graft System
Experimental
Altura Medical AAA Stent Graft System
Intervention: Altura Medical Abdominal Aortic Aneurysm Stent-Graft (Device)
Outcomes
Primary Outcomes
The rate of major adverse events.
Time Frame: 30 days
Adverse events defined as the composite endpoint of death, significant blood loss requiring intervention, respiratory failure, myocardial infarction, renal failure, paralysis, stroke, bowel ischemia and/or device migration causing vascular compromise.
Secondary Outcomes
- Feasibility of device defined by clinical and technical success(6 months, 1 year and 2 years)
Investigators
Study Sites (2)
Loading locations...
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