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

Abdominal Aortic Aneurysms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01346943
• Other study ID #: ALTURA-FIM-1
• Status: Active, not recruiting
• Phase: Phase 1
• First received: May 2, 2011
• Last updated: January 13, 2015
• Start date: April 2011
• Est. completion date: May 2019

Study information

• Verified date: January 2015
• Source: Altura Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Altura Medical Abdominal Aortic Aneurysm Stent-Graft
Altura Medical AAA Stent Graft System

Locations

Country	Name	City	State
Chile	Pontificia Universidad Catolica De Chile	Santiago
Latvia	Stradins University Hospital	Riga

Sponsors (1)

Lead Sponsor	Collaborator
Altura Medical Inc.

Countries where clinical trial is conducted

Chile,  Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes