The Altura Abdominal Aortic Aneurysm (AAA) Endograft Safety and Feasibility Study - Full Text View

Purpose

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	Intervention	Phase
Abdominal Aortic Aneurysms	Device: Altura Medical Abdominal Aortic Aneurysm Stent-Graft	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Altura AAA Endograft Safety and Feasibility Study For Exclusion of Abdominal Aortic Aneurysms

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm

U.S. FDA Resources

Further study details as provided by Altura Medical Inc.:

Primary Outcome Measures:

The rate of major adverse events. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Adverse events defined as the composite endpoint of death, blood loss requiring intervention, repiratory failure, pulmonary embolism, myocardial infarction, renal failure, adynamic ileus, bowel ischemia and/or device migration causing vascular compromise.

Estimated Enrollment:	20
Study Start Date:	April 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 < 60 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 >/= 10mm
Iliac artery diameter between 10 and 20 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 to allow endovascular access
Subject has > one year life expectancy
Subject is not placed at additional risk while waiting for additional imaging
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 follow-up in Poland and 2 year follow-up for patients enrolled in Chile.

Exclusion Criteria:

Subject has an acutely ruptured or leaking 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, suprarenal or mycotic.
Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346943

Contacts

Contact: Stephen A Sosnowski

1-949-273-5050

SSOSNOWSKI@INTERSECTLLC.COM

Locations

Chile
Pontificia Universidad Catolica De Chile	Recruiting
Santiago, Chile, 8330024
Principal Investigator: Albrecht Kramer, MD
Poland
Jagiellonian University John Paul II Hospital	Not yet recruiting
Krakow, Poland, 31-202
Contact: , MD, PhD
Principal Investigator: Jerzy Sadowski, MD,PhD
Skubiszewski Medical University of Lublin	Not yet recruiting
Lublin, Poland
Principal Investigator: Malgorzata Szczerbo-Trojanowska, MD,PhD

Sponsors and Collaborators

Altura Medical Inc.

Investigators

Principal Investigator:

Albrecht Kramer, MD

Pontificia Universidad Catolica de Chile

More Information

No publications provided

Responsible Party:	Stephen A. Sosnowski, Altura Medical Inc.
ClinicalTrials.gov Identifier:	NCT01346943 History of Changes
Other Study ID Numbers:	ALTURA-FIM-1
Study First Received:	May 2, 2011
Last Updated:	May 3, 2011
Health Authority:	Chile: Institutional Review Board

Keywords provided by Altura Medical Inc.:

Abdominal Aortic Aneurysms

Additional relevant MeSH terms:

Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 23, 2013