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A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00349908
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : October 11, 2013
Last Update Posted : June 30, 2014
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff

Brief Summary:
Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries.

Condition or disease Intervention/treatment Phase
Atherosclerosis Aneurysm Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System Phase 1

Detailed Description:
Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries. Patients will be followed for 6 months with assessments related to technical feasibility and adverse events.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
Study Start Date : September 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: Atherosclerosis Arm
Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.
Other Names:
  • Other Names:
  • ENTERPRISE Vascular Reconstruction Device (VRD)
  • ENTERPRISE VRD
  • ENTERPRISE

Active Comparator: Group 2: Aneurysm Arm
Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Implantation of the device ENTERPRISE to treat wide-necked aneurysms
Other Names:
  • ENTERPRISE Vascular Reconstruction Device (VRD)
  • ENTERPRISE VRD
  • ENTERPRISE




Primary Outcome Measures :
  1. Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) [ Time Frame: post procedure ]
    Successful placement of the product assessed immediately post procedure

  2. Technical Feasibility- Percent Occlusion (Post Procedure) [ Time Frame: post procedure ]
    Occlusion evaluated immediately post procedure

  3. Technical Feasibility- Percent Occlusion (6 Mo Post Procedure) [ Time Frame: 6 mo ]
    6 Months post

  4. Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure) [ Time Frame: 6 mo ]
    Successful stent/coil placement assessed at 6 mo post

  5. Technical Feasibility- Percent Stenosis (6 mo Post Procedure) [ Time Frame: 6 mo ]
    Percent Stenosis assessed 6 mo Post Procedure from pre-procedure

  6. Technical Feasibility- Percent Stenosis (Post Procedure) [ Time Frame: Post Procedure ]
    Percent Stenosis assessed immediately post procedure from pre procedure


Secondary Outcome Measures :
  1. The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately. [ Time Frame: 6 months ]
    An adverse event was defined as any untoward medical occurrence in a subject.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Contact site for specific information

Inclusion Criteria:

  • Subject meet specific criteria for treatment
  • Subject must be willing to return to site for 30 day and 6 month follow up evaluations

Exclusion Criteria:

  • Stenting, angioplasty or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date
  • Previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349908


Locations
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Argentina
Eneri-Clinica Adventista Belgrano
Belgrano, Argentina
Sponsors and Collaborators
Codman & Shurtleff
Investigators
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Principal Investigator: Pedro Lylyk, MD ENERI-CLINICA ADVENTISTA BELGRANO

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Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00349908    
Other Study ID Numbers: CNV:ARG:P-01
First Posted: July 10, 2006    Key Record Dates
Results First Posted: October 11, 2013
Last Update Posted: June 30, 2014
Last Verified: May 2014
Keywords provided by Codman & Shurtleff:
Atherosclerosis,Wide Neck Aneurysm
Additional relevant MeSH terms:
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Aneurysm
Atherosclerosis
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases