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Completed

NCT Number: NCT00349908

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

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

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Key information

Conditions

Atherosclerosis Aneurysm Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eneri-Clinica Adventista Belgrano

Belgrano, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Codman & Shurtleff

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jul 10, 2006
Registry last updated
Jun 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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