NCT01346943

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

8.1 years

First QC Date

May 2, 2011

Last Update Submit

January 13, 2015

Conditions

Abdominal Aortic Aneurysms

Keywords

Abdominal Aortic Aneurysms, AAA

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Feasibility of device defined by clinical and technical success

    6 months, 1 year and 2 years

Study Arms (1)

AAA Stent Graft System

EXPERIMENTAL

Altura Medical AAA Stent Graft System

Device: Altura Medical Abdominal Aortic Aneurysm Stent-Graft

Interventions

Altura Medical Abdominal Aortic Aneurysm Stent-GraftDEVICE

Altura Medical AAA Stent Graft System

Also known as: Altura Medical AAA Stent Graft System
AAA Stent Graft System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pontificia Universidad Catolica De Chile

Santiago, 8330024, Chile

Location

Stradins University Hospital

Riga, LV-1002, Latvia

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Albrecht Kramer, MD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 4, 2011

Study Start

April 1, 2011

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

January 15, 2015

Record last verified: 2015-01

Locations

LA(1)CL(1)