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

This study is currently recruiting participants.
Verified December 2013 by Altura Medical Inc.
Sponsor:
Information provided by (Responsible Party):
Altura Medical Inc.
ClinicalTrials.gov Identifier:
NCT01346943
First received: May 2, 2011
Last updated: December 30, 2013
Last verified: December 2013
  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:


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, 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:
  • Feasibility of device defined by clinical and technical success [ Time Frame: 6 months, 1 year and 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (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 < 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346943

Contacts
Contact: Karina K Zarins (650) 543-9223 kzarins@alturamed.com

Locations
Chile
Pontificia Universidad Catolica De Chile Recruiting
Santiago, Chile, 8330024
Contact: Albrecht Kramer       kramer@med.puc.cl   
Principal Investigator: Albrecht Kramer, MD         
Latvia
Stradins University Hospital Recruiting
Riga, Latvia, LV-1002
Principal Investigator: Dainis Krievins, 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: 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: December 30, 2013
Health Authority: Chile: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014