XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery

NCT ID: NCT00731237

Last Updated: 2009-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2517 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-10-31

Brief Summary

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This trial is to assess physician-determined XIENCE V® EECSS acute performance, deliverability and resource utilization in the catheterization lab during commercial use by various physicians with a range of coronary stenting experience

Detailed Description

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This study will evaluate overall physician-determined XIENCE V® Everolimus Eluting Coronary Stent system (XIENCE V®) acute performance, deliverability and resource utilization in the catheterization lab in the "real world" as used by a broad group of physicians at a variety of health care facilities. This study will include all consecutively enrolled patients in the United States of America (USA) who consent to participate and receive XIENCE V® stents.

Conditions

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Atherosclerosis Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

The procedures undergone by this group will be evaluated for: Acute performance, deliverability and resource utilization during the procedure in the catheterization lab during commercial use by various physicians with a range of coronary stenting experience.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* The patient agrees to participate in this study by signing the IRB approved informed consent form prior to the index procedure.
* Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form prior to the index procedure.

Exclusion Criteria

* Inability to obtain an informed consent is an exclusion criterion.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott Vascular

Principal Investigators

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John McPherson, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbuilt University

Locations

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The Heart Center, PC

Huntsville, Alabama, United States

Site Status

Arizona Regional Medical Center

Mesa, Arizona, United States

Site Status

Tri Lakes Research-Central Arkansas Cardiovascular

Hot Springs, Arkansas, United States

Site Status

Tri Lakes Research-Central Arkansas Cardiovascular

Hot Springs Village, Arkansas, United States

Site Status

NEA Baptist Memorial Hospital

Jonesboro, Arkansas, United States

Site Status

La Mesa Cardiac Center

La Mesa, California, United States

Site Status

Pikes Peak Cardiology

Colorado Springs, Colorado, United States

Site Status

University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Bradenton Heart Research Center

Bradenton, Florida, United States

Site Status

Ocala Regional Medical Center

Ocala, Florida, United States

Site Status

Harbin Clinic LLC

Rome, Georgia, United States

Site Status

Sherman Hospital

Elgin, Illinois, United States

Site Status

Heart Care Research Foundation

Mokena, Illinois, United States

Site Status

Northern Indiana Research Alliance

Fort Wayne, Indiana, United States

Site Status

Clarian Health Partners - Methodist Hospital

Indianapolis, Indiana, United States

Site Status

Medical Consultants PC

Muncie, Indiana, United States

Site Status

Iowa Heart Center

Des Moines, Iowa, United States

Site Status

University of Iowa Hospital

Iowa City, Iowa, United States

Site Status

Promise Regional Medical Center - Hutchinson

Hutchinson, Kansas, United States

Site Status

Allegiance Health

Jackson, Michigan, United States

Site Status

Michigan Cardiovascular Institute

Midland, Michigan, United States

Site Status

Michigan Cardio Vascular Institute at St. Mary's of MI

Saginaw, Michigan, United States

Site Status

Coast Cardiovascular Consultants, P.L.L.C

Biloxi, Mississippi, United States

Site Status

St. Luke's

Kansas City, Missouri, United States

Site Status

St. Johns Mercy Medical Center

St Louis, Missouri, United States

Site Status

Renown Regional Medical Center

Reno, Nevada, United States

Site Status

AtlantiCare Regional Medical Center

Pomona, New Jersey, United States

Site Status

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

Site Status

First Health Moore Regional Hospital

Pinehurst, North Carolina, United States

Site Status

Fairfield Cardiac Cath Lab, LLC

Fairfield, Ohio, United States

Site Status

Smith Clinic

Marion, Ohio, United States

Site Status

St. Anthony Hospital

Oklahoma City, Oklahoma, United States

Site Status

Conemaugh Valley Memorial Hospital

Johnstown, Pennsylvania, United States

Site Status

The Good Samaritan Hospital

Lebanon, Pennsylvania, United States

Site Status

Phoenixville Hospital

Phoenixville, Pennsylvania, United States

Site Status

University Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

Site Status

UPMC Presbyterian Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Palmetto Health Clinic

Columbia, South Carolina, United States

Site Status

Piedmont Medical Center / Carolina Cardiology Associates

Rock Hill, South Carolina, United States

Site Status

Wellmont Bristol Regional Medical Center

Bristol, Tennessee, United States

Site Status

Tomball Regional Medical Center

Tomball, Texas, United States

Site Status

Virginia Cardiovascular Specialists

Richmond, Virginia, United States

Site Status

Cardiovascular Associates, Ltd.

Virginia Beach, Virginia, United States

Site Status

CAMC Health Education and Research Institute, Inc.

Charleston, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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08-382

Identifier Type: -

Identifier Source: org_study_id

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