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

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

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

Study Overview

• Status: Unknown
• Conditions: Intracranial Aneurysms; Cavernous Carotid Fistula; Vertebrobasilar Fistula
• Intervention / Treatment: Device: NEC - Neurovascular Embolization Cover

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, 24105
    • Recruiting
    • Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur Neuroradiologie
    • Contact: Olav Jansen, Prof. Dr. med.; Phone Number: 0431-587 4808; Email: o.jansen@neurorad.uni-kiel.de
    • Principal Investigator: Olav Jansen, Prof. Dr. med.
  • Lubeck, Germany, 23538
    • Recruiting
    • Universitatsklinikum Schleswig-Holstein Institut fur Neuroradiologie
    • Contact: Christoph Koch, PD Dr. med.; Phone Number: 0451-500-4506; Email: koch@neuroradiologie.uni-luebeck.de
    • Principal Investigator: Christoph Koch, PD Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects who show complete occlusion of target aneurysm or or fistula as judged by Core Laboratory radiologist by angiography	6 month follow-up
Proportion of subjects who experience neurologic death or ipsilateral stroke	6 month follow-up

Collaborators and Investigators

• Sponsor: Nfocus Neuromedical
• Investigators: Principal Investigator: Olav Jansen, Prof. Dr. med., Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur Neuroradiologie

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Anticipated): December 1, 2010
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: January 20, 2010
• First Submitted That Met QC Criteria: January 20, 2010
• First Posted (Estimate): January 22, 2010

Study Record Updates

• Last Update Posted (Estimate): January 22, 2010
• Last Update Submitted That Met QC Criteria: January 20, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Intracranial Arterial Diseases; Fistula; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: NEC001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No