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NCT00530504 Clinical Trial

Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

Carotid Artery Disease Clinical Trial

— CREATE PAS  

Official title:
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00530504
Other study ID # P-2611
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2007
Est. completion date January 2014

Study information
Verified date February 2019
Source Medtronic Endovascular
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purposes of this study are:

1. To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device.

2. To evaluate rare and unanticipated adverse events.

3. To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.

Recruitment information / eligibility
Status Completed
Enrollment 1500
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years and above

- Informed consent

- Intent to use the PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX and SpiderFX™ to treat carotid artery disease per Instructions for Use

- Meet Instruction for Use (IFU)/ Centers for Medicare & Medicaid Services (CMS)defined anatomical or clinical high risk criteria

Exclusion Criteria:

- Subjects with contraindications as outlined in the Instructions for Use

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device
Carotid artery stenting with distal embolic protection.

Locations
Country Name City State
United States Wellmont Medical Center Kingsport Tennessee
United States Stony Brook University Hospital Stony Brook New York

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure. Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation. 30 Days
See also
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Completed NCT00744523 - Proximal Protection With The Mo.Ma Device During Carotid Stenting N/A
Completed NCT00231231 - Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS) Phase 3
Completed NCT00597974 - Neurological Outcome With Carotid Artery Stenting N/A
Completed NCT00587717 - The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue N/A
Completed NCT02536378 - POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE
Completed NCT02126982 - Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence
Active, not recruiting NCT01445613 - Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy N/A
Terminated NCT01414387 - Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting N/A
Completed NCT00406055 - CHOICE: Carotid Stenting For High Surgical-Risk Patients Phase 4
Completed NCT00403078 - SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
Terminated NCT01968226 - TRACER RGD-K5 Carotid Plaque Imaging Study Phase 2
Completed NCT01685567 - Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure Phase 3
Completed NCT00402740 - Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT) N/A
Completed NCT00287508 - Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study) Phase 4
Completed NCT00178672 - A Single Center of Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease Phase 4
Recruiting NCT02850588 - SVS VQI TransCarotid Revascularization Surveillance Project
Completed NCT02759653 - Norwegian Carotid Plaque Study
Withdrawn NCT01042912 - Frequency Analysis of Carotid Artery Disease N/A

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