Aneurysm Study of Pipeline in an Observational Registry (ASPIRE)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
ev3
ClinicalTrials.gov Identifier:
NCT01557036
First received: March 13, 2012
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Brain Aneurysm
Device: Pipeline Embolization Device

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Aneurysm Study of Pipeline in an Observational Registry

Resource links provided by NLM:


Further study details as provided by ev3:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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


Estimated Enrollment: 1500
Study Start Date: May 2012
Groups/Cohorts Assigned Interventions
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 Name: PED

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557036

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Barrow Neurosurgical Associates
Phoenix, Arizona, United States, 85013
United States, California
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Colorado
Radiology Imaging Associates / Colorado Neurological Institute
Englewood, Colorado, United States, 80113
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Neurointerventional Associates, P.A.
St. Petersburg, Florida, United States, 33701
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kentucky
Neurosurgical Associates at Central Baptist
Lexington, Kentucky, United States, 40503
Norton Neuroscience Institute
Louisville, Kentucky, United States, 40241
United States, Minnesota
Abbott Northwestern Hospital/Consulting Radiologists
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55905
St. Paul Radiology
St. Paul, Minnesota, United States, 55102
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
University of Buffalo Neurosurgery, Buffalo General Hospital
Buffalo, New York, United States, 14203
The State University of New York, Stony Brook
Stony Brook, New York, United States, 11794
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Medical College Of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Argentina
Clínica La Sagrada Familia
Buenos Aires, Argentina, C1426EOB
Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
France
Besançon University Hospital
Besançon, France, 25030
Hôpital Gui de Chauliac
Montpellier, France, 34295
Hôpital Maison Blanche - CHU
Reims, France, 51100
Germany
Alfried Krupp Krankenhaus
Essen, Germany, 45131
Klinikum Stuttgart
Stuttgart, Germany, 70174
Italy
Niguarda CA Granda Hospital of Milan
Milan, Italy, 20162
Fondazione Istituto Neurologico "Besta"
Milano, Italy, 20133
Ospedale San Giovanni Bosco ASL Napoli 1 Centro
Napoli, Italy, 80144
Switzerland
University Hospitals of Geneva (HUG)
Geneva, Switzerland, 1211
Sponsors and Collaborators
ev3
  More Information

No publications provided

Responsible Party: ev3
ClinicalTrials.gov Identifier: NCT01557036     History of Changes
Other Study ID Numbers: PED002
Study First Received: March 13, 2012
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by ev3:
Brain Aneurysm

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 15, 2014