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

NCT ID: NCT01346943

Last Updated: 2015-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2019-05-31

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.

Conditions

Abdominal Aortic Aneurysms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AAA Stent Graft System

Altura Medical AAA Stent Graft System

Group Type: EXPERIMENTAL

Altura Medical Abdominal Aortic Aneurysm Stent-Graft

Intervention Type: DEVICE

Altura Medical AAA Stent Graft System

Interventions

Altura Medical Abdominal Aortic Aneurysm Stent-Graft

Altura Medical AAA Stent Graft System

Intervention Type: DEVICE

Other Intervention Names

Altura Medical AAA Stent Graft System

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Altura Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albrecht Kramer, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

Pontificia Universidad Catolica De Chile

Santiago, , Chile

Stradins University Hospital

Riga, , Latvia

Countries

Chile; Latvia

Other Identifiers

ALTURA-FIM-1

Identifier Type: -

Identifier Source: org_study_id