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

  Show 36 Study Locations
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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014