Clinical trial NCT01346943: The Altura Abdominal Aortic Aneurysm (AAA) Endograft Safety and Feasibility Study
Official title: The Altura AAA Endograft Safety and Feasibility Study For Exclusion of Abdominal Aortic Aneurysms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Abdominal Aortic Aneurysms
Keywords: Abdominal Aortic Aneurysms, AAA
Lead sponsor: Altura Medical Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The rate of major adverse events.
timeFrame: 30 days
Secondary outcomes:
measure: Feasibility of device defined by clinical and technical success
timeFrame: 6 months, 1 year and 2 years
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica De Chile
city: Riga
country: Latvia
facility: Stradins University Hospital
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Albrecht Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References: