The Altura Abdominal Aortic Aneurysm (AAA) Endograft Safety and Feasibility Study

The Altura AAA Endograft Safety and Feasibility Study For Exclusion of Abdominal Aortic Aneurysms

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 Overview

• Status: Unknown
• Conditions: Abdominal Aortic Aneurysms
• Intervention / Treatment: Device: Altura Medical Abdominal Aortic Aneurysm Stent-Graft

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile, 8330024
    • Pontificia Universidad Catolica de Chile
• Latvia
  • Riga, Latvia, LV-1002
    • Stradins University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AAA Stent Graft System; Altura Medical AAA Stent Graft System	Device: Altura Medical Abdominal Aortic Aneurysm Stent-Graft; Altura Medical AAA Stent Graft System; Other Names: Altura Medical AAA Stent Graft System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of major adverse events.	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of device defined by clinical and technical success	Evaluate the feasibility of using Altura AAA Endograft. Feasibility is comprised of acute clinical and technical success measured at the time of procedure. Long-term safety will be evaluated at 6 months, 1 year and 2 years.	6 months, 1 year and 2 years

Collaborators and Investigators

• Sponsor: Altura Medical Inc.
• Investigators: Principal Investigator: Albrecht Kramer, MD, Pontificia Universidad Catolica de Chile

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ANTICIPATED): May 1, 2019
• Study Completion (ANTICIPATED): May 1, 2019

Study Registration Dates

• First Submitted: May 2, 2011
• First Submitted That Met QC Criteria: May 3, 2011
• First Posted (ESTIMATE): May 4, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 15, 2015
• Last Update Submitted That Met QC Criteria: January 13, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Abdominal Aortic Aneurysms, AAA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: ALTURA-FIM-1