Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study - Full Text View

Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study (CREATE PAS)

This study is currently recruiting participants.

Verified April 2012 by ev3

First Received on September 14, 2007. Last Updated on April 3, 2012 History of Changes

Sponsor:	ev3
Information provided by (Responsible Party):	ev3
ClinicalTrials.gov Identifier:	NCT00530504

Purpose

The purposes of this study are:

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.
To evaluate rare and unanticipated adverse events.
To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.

Condition	Intervention	Phase
Carotid Artery Disease	Device: PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

Resource links provided by NLM:

MedlinePlus related topics: Carotid Artery Disease

U.S. FDA Resources

Further study details as provided by ev3:

Primary Outcome Measures:

Composite rate of death, ipsilateral CVA, procedure-related CVA, or myocardial infarction (MI) at 30 days post-procedure. [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	3500
Study Start Date:	May 2007
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Intervention Details:

Carotid artery stenting with distal embolic protection.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530504

Contacts

Contact: Marcus Wilborn, MSHS, RT(R)(CV)

Site Selection Complete

mwilborn@ev3.net

Locations

United States, New York
Stony Brook University Hospital	Recruiting
Stony Brook, New York, United States
Principal Investigator: Allen Jeremias, M.D.
United States, Tennessee
Wellmont Medical Center	Recruiting
Kingsport, Tennessee, United States
Principal Investigator: Christopher Metzger, M.D.

Sponsors and Collaborators

ev3

Investigators

Principal Investigator:	Gary Ansel, MD	MidWest Cardiology Research Foundation
Principal Investigator:	Robert Safian, MD	William Beaumont Hospitals

More Information

Additional Information:

Click here for information on ev3 Endovascular Inc. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	ev3
ClinicalTrials.gov Identifier:	NCT00530504 History of Changes
Other Study ID Numbers:	P-2611
Study First Received:	September 14, 2007
Last Updated:	April 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by ev3:

Carotid Artery Disease
Embolic Protection

Additional relevant MeSH terms:

Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2012