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Clinical Trial Details

NCT ID: NCT01054391
Date Last Changed: January 20, 2010

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Intracranial Aneurysms, Cavernous Carotid Fistula or Vertebrobasilar Fistula

Research Study Title

NEC Trial - Nfocus - Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae - A Non-Randomized Pilot Study

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

To Learn more

Recruitment Details

Gender
Both Male and Female
Age
19 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Nfocus Neuromedical
Duration
26 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 19 Years to 80 Years

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

Site Locations (2)

Country State City Zip Facility and Contact
Germany Kiel 24105 Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur Neuroradiologie
Olav Jansen, Prof. Dr. med.
0431-587 4808
o.jansen@neurorad.uni-kiel.de

Olav Jansen, Prof. Dr. med.
Principal Investigator
Germany Lubeck 23538 Universitatsklinikum Schleswig-Holstein Institut fur Neuroradiologie
Christoph Koch, PD Dr. med.
0451-500-4506
koch@neuroradiologie.uni-luebeck.de

Christoph Koch, PD Dr. med.
Principal Investigator

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