Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Nfocus Neuromedical.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nfocus Neuromedical
ClinicalTrials.gov Identifier:
NCT01054391
First received: January 20, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

The purpose of this study is to determine whether the NEC device can effectively occlude the intracranial aneurysm or the carotid/vertebrobasilar fistula and maintain parent vessel patency


Condition Intervention
Intracranial Aneurysms
Cavernous Carotid Fistula
Vertebrobasilar Fistula
Device: NEC - Neurovascular Embolization Cover

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NEC Trial - Nfocus - Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae - A Non-Randomized Pilot Study

Resource links provided by NLM:


Further study details as provided by Nfocus Neuromedical:

Primary Outcome Measures:
  • Proportion of subjects who show complete occlusion of target aneurysm or or fistula as judged by Core Laboratory radiologist by angiography [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
  • Proportion of subjects who experience neurologic death or ipsilateral stroke [ Time Frame: 6 month follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: October 2008
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NEC Arm
Utilization of NEC (Neurovascular Embolization Cover) for the treatment of intracranial aneurysms and carotid/vertebrobasilar fistulae
Device: NEC - Neurovascular Embolization Cover
Implantation of NEC for the treatment of intracranial aneurysms and carotid/vertebrobasilar fistuale arising from a parent vessel of 2.5 to 4.5mm

Detailed Description:

SAH (subarachnoid hemorrhage) is a devastating medical emergency. As many as 60% of patients who are afflicted die in the first 30 days as a result of the SAH, or remain severely disabled from the bleed. Existing treatment options include: medical management; endovascular therapy and surgical therapy. Endovascular techniques using detachable coils have now been refined to include stents which serve to prevent the coil mass from dislodging. Further improvement is believed to be possible with the NEC which creates a seal to exclude the aneurismal lumen from blood flow without the need for coils. This study involves the endovascular placement of the NEC across the aneurysm neck in order to treat a subset of aneurysms without coils.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of unruptured aneurysm OR ruptured aneurysm in clinically stable patients in whom coils alone are not an efficient treatment in the opinion of the investigator (i.e., large neck or fusiform aneurysm) OR direct fistulae (Type A - traumatic or aneurismal) and indirect if dural branches come from the internal carotid or vertebral artery and cannot be embolized selectively
  • Subject has a confirmed diagnosis of an intracranial (including intracavernous and intrapetrous regions) sidewall saccular aneurysm or carotid vertebrobasilar fistula
  • Parent artery reference diameter is >2.5mm and <4.5mm
  • Subject is an adult above age 18
  • Subject is able to provide written Informed Consent
  • Subject has good general health, is clinically stable, and is considered to be mentally sound
  • Subject is able and is willing to meet all expected requirements of the clinical protocol, including attending the scheduled follow-up examinations for the duration of this trial.

Exclusion Criteria:

  • Subject has subarachnoid hemorrhage (SAH) < three (3) weeks prior to NEC procedure
  • Subject has had prior stenting of the target aneurysm.
  • Subject is contraindicated for antiplatelet therapy,anticoagulant therapy, or radiographic contrast media.
  • Subject has collagen vascular disease.
  • Subject has a contraindication to angiography (e.g., serum creatinine level > 2.5 mg/dL)
  • Subject has evidence of active infection at the time of treatment
  • Subject is pregnant or breastfeeding or unwilling to use birth control for duration of study
  • Subject has participated in a study involving an investigational drug or device within 30 days prior to proposed entry into subject study
  • Subject is unable to comply with study procedures or protocol
  • Subject has co-morbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days
  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: NCT01054391

Locations
Germany
Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur Neuroradiologie Recruiting
Kiel, Germany, 24105
Contact: Olav Jansen, Prof. Dr. med.    0431-587 4808    o.jansen@neurorad.uni-kiel.de   
Principal Investigator: Olav Jansen, Prof. Dr. med.         
Universitatsklinikum Schleswig-Holstein Institut fur Neuroradiologie Recruiting
Lubeck, Germany, 23538
Contact: Christoph Koch, PD Dr. med.    0451-500-4506    koch@neuroradiologie.uni-luebeck.de   
Principal Investigator: Christoph Koch, PD Dr. med.         
Sponsors and Collaborators
Nfocus Neuromedical
Investigators
Principal Investigator: Olav Jansen, Prof. Dr. med. Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur Neuroradiologie
  More Information

No publications provided

Responsible Party: Tom Ross, Vice-President, Nfocus Neuromedical Inc
ClinicalTrials.gov Identifier: NCT01054391     History of Changes
Other Study ID Numbers: NEC001
Study First Received: January 20, 2010
Last Updated: January 20, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Fistula
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 29, 2014