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Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)

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ClinicalTrials.gov Identifier: NCT00857662
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Micro Therapeutics Inc.
Information provided by:
Medtronic Neurovascular Clinical Affairs

Tracking Information
First Submitted Date  ICMJE March 5, 2009
First Posted Date  ICMJE March 9, 2009
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE May 2001
Actual Primary Completion Date April 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2009)
Angiographic reduction in AVM size (volume) of 50% or greater, where angiographic size reduction is defined as the change from the original AVM size prior to any embolization procedure, to the AVM size after the last embolization. [ Time Frame: Post final embolization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00857662 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • Safety will be assessed by the nature and severity of adverse events [ Time Frame: 3 months post discharge ]
  • Surgical blood loss
  • Surgical resection time
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2009)
  • Safety will be assessed by the nature and severity of adverse events [ Time Frame: 3 months post discharge ]
  • Blood Loss [ Time Frame: Post surgical resection ]
  • Surgical resection time [ Time Frame: Post surgical resection ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)
Official Title  ICMJE U.S. Multicenter, Randomized Controlled Study Comparing the Performance fo Onyx(EVOH) and TRUFILL® (n-BCA)in Presurgical Embolization of Brain Arteriovenous Malformations (BAVMs)
Brief Summary Test whether AVMs treated with Onyx is equivalent to treatment with n-BCA. Success is defined as an AVM size reduction greater than 50%
Detailed Description

Recent advances in the endovascular treatment of arteriovenous malformations (AVMs) have increased the number of patients with brain AVMs for whom embolization therapy may be appropriate. The permanency of obliterated nidi and occurrence of procedural complications are thought to be at least partially influenced by the characteristics of the material used, with liquid agents more likely to reach and occlude the AVM nidus compared to particulate embolic agents.

The only liquid embolic agent approved in the U.S. for the presurgical embolization of AVMs is TRUFILL®. TRUFILL n-butyl cyanoacrylate (n-BCA) is a liquid adhesive that polymerizes into a solid material upon contact with blood fluids or tissue, via an anionic mechanism. TRUFILL Ethiodized Oil is mixed into the n-BCA monomer as a radiopaque polymerizing retardant. TRUFILL Tantalum Powder may also be added for radiopacity. The TRUFILL n-BCA Liquid Embolic System received U.S. FDA premarket approval on September 25, 2000 (P990040) for use in the embolization of cerebral AVMs, when presurgical devascularization is desired.

Onyx™ is a non-adhesive liquid embolic agent comprised of ethylene vinyl alcohol (EVOH) copolymer dissolved in dimethyl sulfoxide (DMSO), and of micronized tantalum powder. Onyx precipitates into a solid on contact with blood fluids, due to rapid diffusion of the DMSO solvent. The Onyx Liquid Embolic System received the European "CE mark" in July 1999, and has been available outside of the U.S. since September 1999 for use in the embolization of AVMs.

The purpose of this randomized-controlled study is to obtain prospective clinical data on the performance of Onyx (investigational device) and TRUFILL (control device) in the presurgical embolization of brain AVMs. Device safety will be assessed by comparing overall and device-related morbidity and mortality. The primary efficacy endpoint is the angiographic reduction in AVM size (volume) achieved. The objective is to demonstrate that Onyx is no worse than TRUFILL within a specified clinical tolerance. Study results will be used to support a premarket approval application for Onyx in the presurgical embolization of brain AVMs.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Arteriovenous Malformations
Intervention  ICMJE
  • Device: Onyx
    Embolization
  • Device: TRUFILL
    Embolization
Study Arms  ICMJE
  • Experimental: Onyx
    Intervention: Device: Onyx
  • Active Comparator: TRUFILL
    Intervention: Device: TRUFILL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2009)
117
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date April 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient or patient's guardian understands and will sign the informed consent for the procedure
  • The patient has a confirmed diagnosis of a brain AVM in the cerebral cortex, cerebellum or dura mater as visualized by angiography or cross sectional imaging.
  • The brain AVM has a Spetzler-Martin grade of I, II, III, or IV. If the brain AVM has a Spetzler-Martin grade of I or II, the anticipated benefit of embolization for surgical resection is greater than the risk of the embolization procedure (e.g., patient stability).
  • The patient is a candidate for surgical resection of the AVM post embolization.
  • The patient is clinically and neurologically stable, for a minimum of 24 hours prior to embolization.
  • The patient agrees to have, and is capable of completing, all study-related exams and procedures.
  • Patient of any age.

Exclusion Criteria:

  • The patient is pregnant.
  • The patient has a brain AVM with high flow arteriovenous fistulae that the investigator has determined to be unsuitable for embolization.
  • The brain AVM has a Spetzler-Martin grade of V.
  • The patient is participating in another research study involving another investigational device, procedure or drug.
  • The brain AVM has been previously treated with another embolization agent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00857662
Other Study ID Numbers  ICMJE G000296
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Linda Simpson/Director of Clinical Affairs, Microtherapeutics, Inc dba ev3, Inc
Study Sponsor  ICMJE Medtronic Neurovascular Clinical Affairs
Collaborators  ICMJE Micro Therapeutics Inc.
Investigators  ICMJE
Principal Investigator: Gary Duckwiler, MD University of California, Los Angeles
PRS Account Medtronic Neurovascular Clinical Affairs
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP