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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349908
• Other study ID #: CNV:ARG:P-01
• Status: Completed
• Phase: Phase 1
• First received: July 6, 2006
• Last updated: May 28, 2014
• Start date: September 2006
• Est. completion date: March 2009

Study information

• Verified date: May 2014
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Atherosclerosis

Intervention

Device:
• Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.
• Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Implantation of the device ENTERPRISE to treat wide-necked aneurysms

Locations

Country	Name	City	State
Argentina	Eneri-Clinica Adventista Belgrano	Belgrano

Sponsors (1)

Lead Sponsor	Collaborator
Codman & Shurtleff

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)	Successful placement of the product assessed immediately post procedure	post procedure	No
Primary	Technical Feasibility- Percent Occlusion (Post Procedure)	Occlusion evaluated immediately post procedure	post procedure	No
Primary	Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)	6 Months post	6 mo	No
Primary	Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)	Successful stent/coil placement assessed at 6 mo post	6 mo	No
Primary	Technical Feasibility- Percent Stenosis (6 mo Post Procedure)	Percent Stenosis assessed 6 mo Post Procedure from pre-procedure	6 mo	No
Primary	Technical Feasibility- Percent Stenosis (Post Procedure)	Percent Stenosis assessed immediately post procedure from pre procedure	Post Procedure	No
Secondary	The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately.	An adverse event was defined as any untoward medical occurrence in a subject.	6 months	Yes