Clinical trial NCT01991756: Safety and Performance of Altura Endograft in Abdominal Aortic Aneurysm (AAA) Endovascular Repair
Official title: ELEVATE International: Kissing Endografts for Peripheral AAA Exclusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Aortic Aneurysms
Keywords: Abdominal Aortic Aneurysms
AAA
Lead sponsor: Altura Medical Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease with suitable aneurysm morphology for endovascular repair.

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.

Detailed description: The primary safety endpoint of the study is freedom from Major Adverse Events (MAE), a composite endpoint consisting of death, stroke, paraplegia, myocardial infarction, respiratory failure, renal failure, bowel ischemia and blood loss ≥ 1000 mL.

Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

* 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;
* Coagulopathy or uncontrolled bleeding disorder
* History of heparin-induced thrombocytopenia (HIT)
* Clinically and morbidly obese such that the required imaging would be prevented
* Connective tissue disease (e.g., Marfan's or Ehlers-Danlos syndromes)
* Currently on dialysis or has compromised renal function as reflected by a serum creatinine \>2.0 mg/dL
* Compromised hepatic function
* Active infection at the time of the index procedure
* End-stage chronic obstructive pulmonary disorder (COPD)
* Religious, cultural or other objections to the receipt of blood or blood products
* Participating in another research study involving an investigational device or drug which may potentially affect study results
* 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

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Safety Endpoint
timeFrame: 30 days, 6 and 12 months and annually through 5 years
Other outcomes:
measure: Secondary Performance Endpoint
timeFrame: Procedurally, 30 days, 6 and 12 months and annually through 5 years
Locations:
city: Freiburg
country: Germany
facility: Uniklink
city: Hamburg-Eppendorf
country: Germany
facility: University Heart Center
city: Leipzig
country: Germany
facility: Park-Krankenhaus Leipzig
city: Lingen
country: Germany
facility: Sankt Bonifatius Hospital
Study officials:
affiliation: Park-Krenkenhaus Leipzig
name: Dierk Scheinert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: