Safety and Performance of Altura Endograft in Abdominal Aortic Aneurysm (AAA) Endovascular Repair

NCT01991756 | Unknown

• 1 other identifier: ALTURA-ELE-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of the study is to evaluate the acute safety of deploying and implanting the Altura Endograft in the treatment of AAA in subjects who are candidates for endovascular repair. Secondary objectives are to evaluate the acute and longer-term safety and performance of the Altura Endograft through 5 years.

Conditions

Abdominal Aortic Aneurysms

Keywords

Abdominal Aortic Aneurysms; AAA

Outcome Measures

Primary Outcomes (1)

• Primary Safety Endpoint

  Freedom from Major Adverse Events (MAE), a composite endpoint consisting of: * Death * Stroke * Paraplegia * Myocardial infarction * Respiratory failure * Renal failure * Bowel ischemia * Blood loss ≥ 1000 mL

  30 days

Secondary Outcomes (1)

• Secondary Safety Endpoint

  30 days, 6 and 12 months and annually through 5 years

Other Outcomes (1)

• Secondary Performance Endpoint

  Procedurally, 30 days, 6 and 12 months and annually through 5 years

Study Arms (1)

AAA

Subjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm will be treated with the Altura Endograft System.

Device: Altura Endograft System

Interventions

Altura Endograft System DEVICE

Subjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm.

AAA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease with suitable aneurysm morphology for endovascular repair.

You may qualify if:

• years or older
• Understands and has signed an Informed Consent
• Candidate for endovascular or open surgical repair of an infrarenal aortic or aorto-iliac aneurysm
• Abdominal aneurysm \> 45 mm or aneurysm growth of \> 10 mm/year
• Abdominal aneurysm neck angulation ≤ 60 degrees
• Infrarenal non-aneurysmal neck 15 mm
• Infrarenal non-aneurysmal neck diameter between 18 and 28 mm, inclusive
• Iliac artery landing zone 15 mm in length
• Iliac artery landing zone diameter between 8 and 18 mm, inclusive
• Patent iliac and femoral arteries, access vessels, size and morphology, to allow endovascular access of a minimum 14 Fr introducer sheath and catheter
• Ability to preserve at least one hypogastric artery
• Life expectancy \> one year
• American Society of Anesthesiology (ASA) grade 1 through 3, inclusive
• Able and willing to comply with follow-up visits at 30 days, 6 and 12 months and annually through 5 years

You may not qualify if:

• Pregnant or nursing
• An acutely ruptured, leaking or emergent aneurysm
• An aortic dissection (Type A or B)
• A mycotic, infected or inflammatory aneurysm
• A thoracic, suprarenal or juxtarenal aneurysm
• Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm or an aorto-iliac aneurysm
• Severe iliac artery tortuosity
• Thrombus, calcification and/or plaque that may complicate sealing
• Evidence or history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the past 3 months
• Current angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia or valvular disease
• Had or plans to have an unrelated major surgical or interventional procedure within 1 month before or after implantation of the study device
• Significant (\>80%) diameter renal artery stenosis which could not be readily treated
• Known sensitivity or allergy to nitinol or polyester
• Known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment
• Contraindication to antiplatelet, anticoagulant or thrombolytic therapy;

Sponsors & Collaborators

• Altura Medical Inc.: lead

Study Sites (4)

Uniklink

Freiburg im Breisgau, Germany

Location

University Heart Center

Hamburg-Eppendorf, Germany

Location

Park-Krankenhaus Leipzig

Leipzig, Germany

Location

Sankt Bonifatius Hospital

Lingen, Germany

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Dierk Scheinert, MD, PhD

  Park-Krenkenhaus Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: April 1, 2014
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

DE (4)