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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01346943
Recruitment Status : Active, not recruiting
First Posted : May 4, 2011
Last Update Posted : January 15, 2015
Information provided by (Responsible Party):
Altura Medical Inc.

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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysms Device: Altura Medical Abdominal Aortic Aneurysm Stent-Graft Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Altura AAA Endograft Safety and Feasibility Study For Exclusion of Abdominal Aortic Aneurysms
Study Start Date : April 2011
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

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 Name: Altura Medical AAA Stent Graft System

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Feasibility of device defined by clinical and technical success [ Time Frame: 6 months, 1 year and 2 years ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01346943

Pontificia Universidad Catolica De Chile
Santiago, Chile, 8330024
Stradins University Hospital
Riga, Latvia, LV-1002
Sponsors and Collaborators
Altura Medical Inc.
Principal Investigator: Albrecht Kramer, MD Pontificia Universidad Catolica de Chile

Responsible Party: Altura Medical Inc. Identifier: NCT01346943     History of Changes
Other Study ID Numbers: ALTURA-FIM-1
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015

Keywords provided by Altura Medical Inc.:
Abdominal Aortic Aneurysms, AAA

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases