Overview

This trial is active, not recruiting.

Condition abdominal aortic aneurysms
Treatment altura medical abdominal aortic aneurysm stent-graft
Phase phase 1
Sponsor Altura Medical Inc.
Start date April 2011
End date May 2019
Trial size 50 participants
Trial identifier NCT01346943, ALTURA-FIM-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Altura Medical AAA Stent Graft System
altura medical abdominal aortic aneurysm stent-graft Altura Medical AAA Stent Graft System
Altura Medical AAA Stent Graft System

Primary Outcomes

Measure
The rate of major adverse events.
time frame: 30 days

Secondary Outcomes

Measure
Feasibility of device defined by clinical and technical success
time frame: 6 months, 1 year and 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title The Altura AAA Endograft Safety and Feasibility Study For Exclusion of Abdominal Aortic Aneurysms
Principal investigator Albrecht Kramer, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Altura Medical Inc..