AtherosclerosisPhase 1NCT00349908

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

A Phase 1 study testing Cordis Neurovascular ENTERPRISE Self Expanding Stent System in people with Atherosclerosis and Aneurysm, run by Codman & Shurtleff at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Atherosclerosis, Aneurysm
What is being tested?: Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteArgentina
Study dates: Sep 2006to Mar 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Argentina1 site

Eneri-Clinica Adventista Belgrano
Belgrano

Other trials in Argentina

About this study

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

Read the 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.

Conditions: Atherosclerosis, Aneurysm
Being tested: Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Keywords: Atherosclerosis,Wide Neck Aneurysm
Medical subject headings: Atherosclerosis, Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cordis Neurovascular ENTERPRISE Self Expanding Stent SystemDevice
Also called Other Names:, ENTERPRISE Vascular Reconstruction Device (VRD), ENTERPRISE VRD, ENTERPRISE
Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.
Cordis Neurovascular ENTERPRISE Self Expanding Stent SystemDevice
Also called ENTERPRISE Vascular Reconstruction Device (VRD), ENTERPRISE VRD, ENTERPRISE
Implantation of the device ENTERPRISE to treat wide-necked aneurysms

Study groups in NCT00349908
Study group	Role	What they receive
Group 1: Atherosclerosis Arm	Experimental	Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System Receives: Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Group 2: Aneurysm Arm	Active comparator	Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System Receives: Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)
Successful placement of the product assessed immediately post procedure
Measured: post procedure
Technical Feasibility- Percent Occlusion (Post Procedure)
Occlusion evaluated immediately post procedure
Measured: post procedure
Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)
6 Months post
Measured: 6 mo
Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)
Successful stent/coil placement assessed at 6 mo post
Measured: 6 mo
Technical Feasibility- Percent Stenosis (6 mo Post Procedure)
Percent Stenosis assessed 6 mo Post Procedure from pre-procedure
Measured: 6 mo
Technical Feasibility- Percent Stenosis (Post Procedure)
Percent Stenosis assessed immediately post procedure from pre procedure
Measured: Post 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.
An adverse event was defined as any untoward medical occurrence in a subject.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Mar 2009

First posted10 Jul 2006 (estimated)
Study startSep 2006
Primary completionOct 2008
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AtherosclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00349908
Sponsor's protocol ID: CNV:ARG:P-01
Status last verified: May 2014
First submitted: 6 Jul 2006
Last updated: 30 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Atherosclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
ClinicalTrials.gov ID: NCT00349908
Acronym / sponsor ID: CNV:ARG:P-01
Conditions: Atherosclerosis, Aneurysm
Keywords: Atherosclerosis,Wide Neck Aneurysm
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Codman & ShurtleffIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Oct 2008 (actual)
Study completion: Mar 2009 (actual)
First posted: 10 Jul 2006 (estimated)
Results: Posted 11 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1: Atherosclerosis Arm	Experimental	Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent SystemImplant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Group 2: Aneurysm Arm	Active comparator	Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent SystemImplant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cordis Neurovascular ENTERPRISE Self Expanding Stent SystemAlso: Other Names:, ENTERPRISE Vascular Reconstruction Device (VRD), ENTERPRISE VRD, ENTERPRISEImplantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.	Device	Group 1: Atherosclerosis Arm
Cordis Neurovascular ENTERPRISE Self Expanding Stent SystemAlso: ENTERPRISE Vascular Reconstruction Device (VRD), ENTERPRISE VRD, ENTERPRISEImplantation of the device ENTERPRISE to treat wide-necked aneurysms	Device	Group 2: Aneurysm Arm

Primary outcome

Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)
Time frame: post procedure
Successful placement of the product assessed immediately post procedure
Technical Feasibility- Percent Occlusion (Post Procedure)
Time frame: post procedure
Occlusion evaluated immediately post procedure
Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)
Time frame: 6 mo
6 Months post
Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)
Time frame: 6 mo
Successful stent/coil placement assessed at 6 mo post
Technical Feasibility- Percent Stenosis (6 mo Post Procedure)
Time frame: 6 mo
Percent Stenosis assessed 6 mo Post Procedure from pre-procedure
Technical Feasibility- Percent Stenosis (Post Procedure)
Time frame: Post Procedure
Percent Stenosis assessed immediately post procedure from pre procedure

1 secondary outcome

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

Results and safety

Results posted to the registry on 11 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aneurysm Arm	10	10
Atherosclerosis Arm	10	6

Primary outcome: Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)

Time frame: post procedure. Number. Unit: percentage of stable placement

Measure	Group 1 n = 10	Group 2 n = 10
Value	100 (47.3)	90 (14.7)

Primary outcome: Technical Feasibility- Percent Occlusion (Post Procedure)

Time frame: post procedure. Mean (Full Range). Unit: percent occlusion

Measure	Group 1 n = 0	Group 2 n = 10
Value	–	86.8 (0 to 100)

Population analysed: Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.

Primary outcome: Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)

Time frame: 6 mo. Mean (Full Range). Unit: percent occlusion

Measure	Group 1 n = 0	Group 2 n = 10
Value	–	88.8 (0 to 100)

Population analysed: Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.

Primary outcome: Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)

Time frame: 6 mo. Number. Unit: Percentage of stable stent/coil placemen

Measure	Group 1 n = 10	Group 2 n = 10
Value	100	100

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Atherosclerosis Arm	3 of 10 (30%)	8 of 10 (80%)	Not reported
Group 2: Aneurysm Arm	3 of 10 (30%)	9 of 10 (90%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atherosclerosis

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Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
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Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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RecruitingPhase 3
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pedro Lylyk, MD principal investigator

ENERI-CLINICA ADVENTISTA BELGRANO

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cordis Neurovascular ENTERPRISE Self Expanding Stent System in people with Atherosclerosis and Aneurysm, run by Codman & Shurtleff at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) (time frame: post procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00349908.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2014.