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

C

Codman & Shurtleff

Status and phase

Completed
Phase 1

Conditions

Aneurysm
Atherosclerosis

Treatments

Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00349908
CNV:ARG:P-01

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Group 1: Atherosclerosis Arm
Experimental group
Description:
Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Treatment:
Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Group 2: Aneurysm Arm
Active Comparator group
Description:
Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Treatment:
Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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