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 by ev3 Endovascular, Inc., December 2008

First Received: September 14, 2007 Last Updated: December 5, 2008 History of Changes

Sponsor:	ev3 Endovascular, Inc.
Information provided by:	ev3 Endovascular, Inc.
ClinicalTrials.gov Identifier:	NCT00530504

Purpose

The purposes of this study are:

To confirm the PROTÉGÉ ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device are safe and effective in the treatment of carotid artery stenosis for subjects with a high risk for complications during carotid endarterectomy.
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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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 Endovascular, Inc.:

Primary Outcome Measures:

Composite rate of death, ipsilateral CVA, procedure-related CVA, or myocardial infarction (MI) at 30 days post-procedure; and the rate of ipsilateral stroke from 31 days to one year. [ Time Frame: 30 Days and One Year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1500
Study Start Date:	May 2007
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (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 protocol defined anatomical or clinical high risk criteria

Exclusion Criteria:

Subjects must not meet general or angiographic exclusion criteria as defined in the protocol
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: Marie Steinbrink

763-398-7336

msteinbrink@ev3.net

Locations

United States, Michigan
William Beaumont	Recruiting
Royal Oak, Michigan, United States
United States, Ohio
Midwest Cardiology	Recruiting
Columbus, Ohio, United States

Sponsors and Collaborators

ev3 Endovascular, Inc.

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 carotid artery disease. This link exits the ClinicalTrials.gov site

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

No publications provided

Responsible Party:	William Beaumont Hospital ( Robert Safian, National Principal Investigator )
Study ID Numbers:	P-2611
Study First Received:	September 14, 2007
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00530504 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ev3 Endovascular, Inc.:

Carotid Artery Disease
Embolic Protection

Additional relevant MeSH terms:

Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Cardiovascular Diseases

Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on February 08, 2010