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

Abbott Medical Devices2,517 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

2,517

Conditions

Atherosclerosis Coronary Artery Disease

Eligibility

Sex: ALL

Medical Language ↔ Plain English

General 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. General Exclusion Criteria: * Inability to obtain an informed consent is an exclusion criterion.

Locations (44)

Outcomes

Primary Outcomes

Overall physician-determined XIENCE V® EECSS acute performance and deliverability.

Time frame: acute

Physician-determined procedure success

Time frame: acute

Secondary Outcomes

Individual component of adjunctive devices and drugs used during procedure. Number and type of guide wires

Time frame: acute

Individual component of adjunctive devices and drugs used during procedure. Number and type of guiding catheters

Time frame: acute

Individual component of adjunctive devices and drugs used during procedure. Number and type of balloon dilation catheters

Time frame: acute

Individual component of adjunctive devices and drugs used during procedure: Balloon pressures (pre-dilation/post-dilation pressures)

Time frame: acute

Individual component of adjunctive devices and drugs used during procedure: Number of stents

Time frame: acute

Individual component of adjunctive devices and drugs used during procedure: Amount of radiographic contrast

Time frame: acute

Individual component of adjunctive devices and drugs used during procedure: Fluoroscopy time

Time frame: acute

Individual component of adjunctive devices and drugs used during procedure: Duration of PCI procedure

Time frame: acute

Data from ClinicalTrials.gov

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The Heart Center, PC

Huntsville, Alabama, United States

Arizona Regional Medical Center

Mesa, Arizona, United States

Tri Lakes Research-Central Arkansas Cardiovascular

Hot Springs, Arkansas, United States

Tri Lakes Research-Central Arkansas Cardiovascular

Hot Springs Village, Arkansas, United States

NEA Baptist Memorial Hospital

Jonesboro, Arkansas, United States

La Mesa Cardiac Center

La Mesa, California, United States

Pikes Peak Cardiology

Colorado Springs, Colorado, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

Bradenton Heart Research Center

Bradenton, Florida, United States

Ocala Regional Medical Center

Ocala, Florida, United States

...and 34 more locations