Back to results

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

Primary Purpose

Intracranial Aneurysms, Cavernous Carotid Fistula, Vertebrobasilar Fistula

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

NEC - Neurovascular Embolization Cover

About this trial

This is an interventional treatment trial for Intracranial Aneurysms

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur NeuroradiologieRecruiting
Universitatsklinikum Schleswig-Holstein Institut fur NeuroradiologieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NEC Arm

Arm Description

Utilization of NEC (Neurovascular Embolization Cover) for the treatment of intracranial aneurysms and carotid/vertebrobasilar fistulae

Outcomes

Primary Outcome Measures

Proportion of subjects who show complete occlusion of target aneurysm or or fistula as judged by Core Laboratory radiologist by angiography

Proportion of subjects who experience neurologic death or ipsilateral stroke

Secondary Outcome Measures

Full Information

NCT ID

NCT01054391

First Posted

January 20, 2010

Last Updated

January 20, 2010

Sponsor

Nfocus Neuromedical

1. Study Identification

Unique Protocol Identification Number

NCT01054391

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

October 2008 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Nfocus Neuromedical

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Aneurysms, Cavernous Carotid Fistula, Vertebrobasilar Fistula

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NEC Arm

Arm Type

Experimental

Arm Description

Utilization of NEC (Neurovascular Embolization Cover) for the treatment of intracranial aneurysms and carotid/vertebrobasilar fistulae

Intervention Type

Device

Intervention Name(s)

NEC - Neurovascular Embolization Cover

Intervention Description

Implantation of NEC for the treatment of intracranial aneurysms and carotid/vertebrobasilar fistuale arising from a parent vessel of 2.5 to 4.5mm

Primary Outcome Measure Information:

Title

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

Title

Proportion of subjects who experience neurologic death or ipsilateral stroke

Time Frame

6 month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olav Jansen, Prof. Dr. med.

Organizational Affiliation

Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur Neuroradiologie

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur Neuroradiologie

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olav Jansen, Prof. Dr. med.

Phone

0431-587 4808

o.jansen@neurorad.uni-kiel.de

First Name & Middle Initial & Last Name & Degree

Olav Jansen, Prof. Dr. med.

Facility Name

Universitatsklinikum Schleswig-Holstein Institut fur Neuroradiologie

City

Lubeck

ZIP/Postal Code

23538

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christoph Koch, PD Dr. med.

Phone

0451-500-4506

koch@neuroradiologie.uni-luebeck.de

First Name & Middle Initial & Last Name & Degree

Christoph Koch, PD Dr. med.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs