Trial record 1 of 1 for:    NCT00777088
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Pipeline for Uncoilable or Failed Aneurysms (PUFS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ev3
ClinicalTrials.gov Identifier:
NCT00777088
First received: October 20, 2008
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms.


Condition Intervention
Intracranial Aneurysm
Device: Pipeline Embolization Device (PED)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pipeline for Uncoilable or Failed Aneurysms

Resource links provided by NLM:


Further study details as provided by ev3:

Primary Outcome Measures:
  • Occurrence of ipsilateral stroke or neurovascular death. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of complete target aneurysm occlusion [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]
  • Incidence of device-related adverse events [ Time Frame: 3 and 5 years ] [ Designated as safety issue: Yes ]
  • Stenosis of the parent artery in PED [ Time Frame: 3 and 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 135
Study Start Date: October 2008
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pipeline
Placement of Pipeline Embolization Device in the parent artery at the aneurysm location
Device: Pipeline Embolization Device (PED)
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach

Detailed Description:

Patients with large or giant aneurysms of the internal carotid artery treated with PED. Angiographic follow-up occurs at 3 and 5 years.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21 to 75 years, inclusive
  • Patient has a single target IA in the anterior or posterior circulation that:

    a) Is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous

    b) Has a neck >4 mm or no discernible neck AND a size (maximum fundus diameter) >10 mm

    c) Has a parent vessel with diameter 2.5 - 5.0 mm distal/proximal to the target IA

  • Subject has provided written informed consent using the IRB-approved consent form
  • Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements

Exclusion Criteria:

  • More than one IA requires treatment in the next 6 months
  • Subarachnoid hemorrhage from target IA in the past 60 days
  • Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
  • Irreversible bleeding disorder
  • Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
  • Inability to tolerate, documented evidence of adverse reaction or contraindication to study medications
  • Stent in place at the target IA
  • Contraindication to CT scan or MRI
  • Allergy to contrast used in angiography that cannot be medically controlled
  • Known severe allergy to platinum or cobalt/chromium alloys
  • Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL)
  • Woman of child-bearing potential who cannot provide a negative pregnancy test
  • Evidence of active infection at the time of treatment
  • Other conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events (e.g., severe heart failure, atrial fibrillation, known carotid stenosis)
  • Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days
  • Extracranial stenosis greater than 50% in the carotid artery for anterior circulation aneurysms
  • Intracranial stenosis greater than 50% in the treated vessel
  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: NCT00777088

Locations
United States, Arizona
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
United States, Illinois
Rush University
Chicago, Illinois, United States
Central Du Page Hospital
Winfield, Illinois, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States
United States, Missouri
Washington University St. Louis
St. Louis, Missouri, United States
United States, New York
University of Buffalo
Buffalo, New York, United States
New York University
New York, New York, United States
Stony Brook University
Stony Brook, New York, United States
Hungary
National Institute of Neurosurgery
Budapest, Hungary
Turkey
Hacettepe University
Ankara, Turkey
Sponsors and Collaborators
ev3
Investigators
Principal Investigator: Tibor Bescke, MD New York University
  More Information

No publications provided

Responsible Party: ev3
ClinicalTrials.gov Identifier: NCT00777088     History of Changes
Other Study ID Numbers: COVPUFS0398
Study First Received: October 20, 2008
Last Updated: August 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ev3:
neurovascular embolization
therapeutic embolization

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 July 29, 2014