Clinical trial NCT00731237: XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery
Official title: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Coronary Artery Disease
Keywords: Drug Eluting Stent
Percutaneous Coronary Intervention
Everolimus
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 2517
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing planned or possible PCI should be invited to participate in the study.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall physician-determined XIENCE V® EECSS acute performance and deliverability.
timeFrame: acute
measure: Physician-determined procedure success
timeFrame: acute
Secondary outcomes:
measure: Individual component of adjunctive devices and drugs used during procedure. Number and type of guide wires
timeFrame: acute
measure: Individual component of adjunctive devices and drugs used during procedure. Number and type of guiding catheters
timeFrame: acute
measure: Individual component of adjunctive devices and drugs used during procedure. Number and type of balloon dilation catheters
timeFrame: acute
measure: Individual component of adjunctive devices and drugs used during procedure: Balloon pressures (pre-dilation/post-dilation pressures)
timeFrame: acute
measure: Individual component of adjunctive devices and drugs used during procedure: Number of stents
timeFrame: acute
measure: Individual component of adjunctive devices and drugs used during procedure: Amount of radiographic contrast
timeFrame: acute
measure: Individual component of adjunctive devices and drugs used during procedure: Fluoroscopy time
timeFrame: acute
measure: Individual component of adjunctive devices and drugs used during procedure: Duration of PCI procedure
timeFrame: acute
measure: Individual component of adjunctive devices and drugs used during procedure: IVUS use
timeFrame: acute
measure: Individual component of adjunctive devices and drugs used during procedure: Thienopyridine loading dose (prior to, during or after procedure)
timeFrame: acute
measure: Individual component of adjunctive devices and drugs used during procedure: Aspirin loading dose (prior to, during or after procedure)
timeFrame: acute
measure: Device Success
timeFrame: acute
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: The Heart Center, PC
state: Alabama
city: Mesa
country: United States
facility: Arizona Regional Medical Center
state: Arizona
city: Hot Springs National Park
country: United States
facility: Tri Lakes Research-Central Arkansas Cardiovascular
state: Arkansas
city: Hot Springs Village
country: United States
facility: Tri Lakes Research-Central Arkansas Cardiovascular
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Baptist Memorial Hospital
state: Arkansas
city: La Mesa
country: United States
facility: La Mesa Cardiac Center
state: California
city: Colorado Springs
country: United States
facility: Pikes Peak Cardiology
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Bradenton
country: United States
facility: Bradenton Heart Research Center
state: Florida
city: Ocala
country: United States
facility: Ocala Regional Medical Center
state: Florida
city: Rome
country: United States
facility: Harbin Clinic LLC
state: Georgia
city: Elgin
country: United States
facility: Sherman Hospital
state: Illinois
city: Mokena
country: United States
facility: Heart Care Research Foundation
state: Illinois
city: Fort Wayne
country: United States
facility: Northern Indiana Research Alliance
state: Indiana
city: Indianapolis
country: United States
facility: Clarian Health Partners - Methodist Hospital
state: Indiana
city: Muncie
country: United States
facility: Medical Consultants PC
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospital
state: Iowa
city: Hutchinson
country: United States
facility: Promise Regional Medical Center - Hutchinson
state: Kansas
city: Jackson
country: United States
facility: Allegiance Health
state: Michigan
city: Midland
country: United States
facility: Michigan Cardiovascular Institute
state: Michigan
city: Saginaw
country: United States
facility: Michigan Cardio Vascular Institute at St. Mary's of MI
state: Michigan
city: Biloxi
country: United States
facility: Coast Cardiovascular Consultants, P.L.L.C
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's
state: Missouri
city: St. Louis
country: United States
facility: St. Johns Mercy Medical Center
state: Missouri
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Pomona
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Pinehurst
country: United States
facility: First Health Moore Regional Hospital
state: North Carolina
city: Fairfield
country: United States
facility: Fairfield Cardiac Cath Lab, LLC
state: Ohio
city: Marion
country: United States
facility: Smith Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: St. Anthony Hospital
state: Oklahoma
city: Johnstown
country: United States
facility: Conemaugh Valley Memorial Hospital
state: Pennsylvania
city: Lebanon
country: United States
facility: The Good Samaritan Hospital
state: Pennsylvania
city: Phoenixville
country: United States
facility: Phoenixville Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Shadyside Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Health Clinic
state: South Carolina
city: Rock Hill
country: United States
facility: Piedmont Medical Center / Carolina Cardiology Associates
state: South Carolina
city: Bristol
country: United States
facility: Wellmont Bristol Regional Medical Center
state: Tennessee
city: Tomball
country: United States
facility: Tomball Regional Medical Center
state: Texas
city: Richmond,
country: United States
facility: Virginia Cardiovascular Specialists
state: Virginia
city: Virginia Beach,
country: United States
facility: Cardiovascular Associates, Ltd.
state: Virginia
city: Charleston
country: United States
facility: CAMC Health Education and Research Institute, Inc.
state: West Virginia
Study officials:
affiliation: Vanderbuilt University
name: John McPherson, MD
role: PRINCIPAL_INVESTIGATOR
References: