Aneurysm Study of Pipeline in an Observational Registry (ASPIRE)

January 19, 2015 updated by: Medtronic Neurovascular Clinical Affairs
The primary objective of this study is to further expand the body of clinical knowledge in patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial aneurysms (IAs or ICAs) according to Pipeline's labeled indication.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426EOB
        • Clínica La Sagrada Familia
  • Belgium
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
  • France
      • Besançon, France, 25030
        • Besançon University Hospital
      • Montpellier, France, 34295
        • Hopital Gui de Chauliac
      • Reims, France, 51100
        • Hôpital Maison Blanche - CHU
  • Germany
      • Essen, Germany, 45131
        • Alfried Krupp Krankenhaus
      • Stuttgart, Germany, 70174
        • Klinikum Stuttgart
  • Italy
      • Milan, Italy, 20162
        • Niguarda CA Granda Hospital of Milan
      • Milano, Italy, 20133
        • Fondazione Istituto Neurologico "Besta"
      • Napoli, Italy, 80144
        • Ospedale San Giovanni Bosco ASL Napoli 1 Centro
  • Switzerland
      • Geneva, Switzerland, 1211
        • University Hospitals of Geneva (HUG)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurosurgical Associates
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Radiology Imaging Associates / Colorado Neurological Institute
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • St. Petersburg, Florida, United States, 33701
        • Neurointerventional Associates, P.A.
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Neurosurgical Associates at Central Baptist
      • Louisville, Kentucky, United States, 40241
        • Norton Neuroscience Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital/Consulting Radiologists
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • St. Paul, Minnesota, United States, 55102
        • St. Paul Radiology
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • Buffalo, New York, United States, 14203
        • University of Buffalo Neurosurgery, Buffalo General Hospital
      • Stony Brook, New York, United States, 11794
        • The State University of New York, Stony Brook
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Houston, Texas, United States, 77030
        • St. Luke's Episcopal Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin/Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with an intracranial aneurysm meeting the labeled indication for the relevant geography.

Description

Inclusion Criteria:

(All sites, All countries)

  1. At least 1 Pipeline placed for treatment of an ICA
  2. Patient or patient's Legally Authorized Representative (LAR) has signed an IRB- or EC-approved informed consent form, if required
  3. Patient is willing and able to comply with follow-up visits

United States: Additional Inclusion Criteria for subjects enrolled in the United States:

4US) Subjects who are age 22 or higher 5US) IA of at least 10 mm in maximum dimension along the internal carotid artery between the petrous and superior hypophyseal segments

Canada: Additional Inclusion Criteria for subjects enrolled in Canada:

4C) In Canada, the Pipeline™ Embolization Device is intended for use with or without embolic coils for the treatment of complex intracranial aneurysms that are not amenable to treatment with surgical clipping.

5C) Canadian licensing/approval is limited to devices that are between 3.25 mm and 5.00 mm in diameter.

France: Additional Inclusion Criteria for subjects enrolled in France:

4F) Unruptured IA, saccular or fusiform with an aneurysm sac diameter > 15mm and not treatable with other current therapies ( EVT with coils with or without assisting system (intracranial stent) or balloon remodeling, or surgery) due to its specific morphology.

5F) IA previously treated with unruptured recanalization of the aneurismal sac > 7 mm, not treatable with conservative treatment.

Exclusion Criteria: (based on contraindications PED IFU)

  1. Active bacterial infection
  2. A patient in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated
  3. A patient who has not received dual antiplatelet agents prior to the procedure
  4. Pre-existing stent is in place in the parent artery at the target aneurysm location
  5. Angiography demonstrates inappropriate anatomy, e.g., severe pre-or post-aneurysm narrowing
  6. Acutely ruptured aneurysm, defined as rupture of the target aneurysm Each site should refer to their country specific Instructions for Use/Approval(France) to determine final eligibility into the ASPIRe Registry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aneurysms treated with Pipleline
Aneurysms treated with Pipleline. All patients independently treated according to the labeled indications for use with the Pipeline Embolization Device
Device: Pipeline Embolization Device
Aneurysms treated independent of study entry with the Pipeline Embolization Device. This is an observational, non-interventional study.
Other Names:
  • PED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Neurological Adverse Events following PED use
Time Frame: From Device placement until last follow up, for an average of 3 years of follow up for each subject enrolled

The primary endpoint will consist of a composite of any/all of the events listed below.

  • Incidence of spontaneous rupture of Pipeline treated aneurysm
  • Incidence of other (non-aneurysmal) intracranial hemorrhage, ipsilateral and contralateral
  • Incidence of ischemic stroke
  • Incidence of symptomatic and asymptomatic parent artery stenosis
  • Incidence of permanent cranial neuropathy
  • Incidence of change in baseline neurologic signs/symptoms related to Pipeline treated ICA(s) at last assessment
From Device placement until last follow up, for an average of 3 years of follow up for each subject enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Neurovascular Clinical Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (ESTIMATE)

March 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Aneurysm

Clinical Trials on Pipeline Embolization Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe