Viewing Study NCT00001364



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001364
Status: COMPLETED
Last Update Posted: 2017-07-02
First Post: 1999-11-03

Brief Title: Evaluation and Treatment of Patients Spinal Blood Vessel Abnormalities
Sponsor: National Institute of Neurological Disorders and Stroke NINDS
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Evaluation and Treatment of Patients With Spinal Vascular Abnormalities
Status: COMPLETED
Status Verified Date: 2007-12-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Arteriovenous malformations AVM are abnormally formed blood vessels that can be located throughout the brain and spinal cord Patients with abnormalities of the blood vessels located in and around the spinal cord can develop many neurological problems Some problems include weakness pain difficulty walking paralysis and even death

The treatment for these AVMs depends on their location the type of malformation the area of the spine involved and the condition of the patient at the time of treatment The treatment is aimed at stopping the neurologic problems from worsening and possibly correcting the existing problems There are two commonly used treatments for AVMs surgery and embolization blocking off of blood flow to the AVM

However researchers have limited experience treating these conditions because they are rare In addition it has been difficult to classify different kinds of AVMs and to develop new treatments for them

This study is designed to increase researchers understanding of AVMs by admitting and following patients diagnosed with the condition By increasing the amount of patients studied diagnosed with spinal blood vessel abnormalities researchers can begin to develop new management plans for patients with AVMs
Detailed Description: Spinal Arteriovenous Malformations are rare lesions that frequently effect young patients and adults in their most productive years They cause progressive myelopathy ultimately causing paraplegia or quadriplegia if untreated Because they are rare lesions experience with treating them in sufficient numbers to permit classification of them investigation of the pathophysiology of myelopathy and the introduction of new techniques for treatment has been possible in only a very few centers in this country One essential element of investigation of them is selective spinal arteriography Since selective spinal arteriography was first introduced for these lesions here at the NIH in the mid 1960s by Drs John Doppman and Giovanni DiChiro the NIH has been such a center of expertise for patients with spinal arteriovenous malformations Because of this NIH has been and is a national referral center for these patients However there has never been an approved protocol at the NIH for investigation or treatment of these patients The purpose of this proposal is to present a plan of investigation and treatment which will serve as a protocol under which to admit these patients and to permit continued accrual of clinical experience with them that will serve to guide others in the management of these patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
93-N-0151 None None None