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

Abdominal Aortic Aneurysms Clinical Trial

— ELEVATE  

Official title:

ELEVATE International: Kissing Endografts for Peripheral AAA Exclusion

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01991756
• Other study ID #: ALTURA-ELE-1
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 18, 2013
• Last updated: January 13, 2015
• Start date: April 2014
• Est. completion date: March 2020

Study information

• Verified date: January 2015
• Source: Altura Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethikkommission an der medizinischen Fakultat
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Device:
• Altura Endograft System
Subjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm.

Locations

Country	Name	City	State
Germany	Uniklink	Freiburg
Germany	University Heart Center	Hamburg-Eppendorf
Germany	Park-Krankenhaus Leipzig	Leipzig
Germany	Sankt Bonifatius Hospital	Lingen

Sponsors (1)

Lead Sponsor	Collaborator
Altura Medical Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Secondary Performance Endpoint	Acute Technical Success; Longer-term Technical Success, defined as subjects having Acute Technical Success and no evidence of; Migration (greater than or equal to 10 mm); Occlusion; Clinical Success, defined as subjects having Acute Technical Success and no evidence of; Type I or Type III endoleaks; AAA rupture; Re-intervention (surgical or endovascular) to correct Type I or Type III endoleaks, migration, occlusion, narrowing, stenosis, kinking or fracture.; Change in aneurysm sac size diameter; Absolute change (mm)	Procedurally, 30 days, 6 and 12 months and annually through 5 years	No
Primary	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	Yes
Secondary	Secondary Safety Endpoint	Major Adverse Events (MAE); Aneurysm-related death; Type I and III endoleaks; AAA rupture; Re-intervention to correct Type I or Type III endoleaks, migration, occlusion, narrowing, stenosis, kinking or fracture	30 days, 6 and 12 months and annually through 5 years	Yes