XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery
EXCEED
XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery
1 other identifier
observational
2,517
1 country
44
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2008
Shorter than P25 for all trials
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedOctober 16, 2009
October 1, 2009
5 months
August 5, 2008
October 15, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall physician-determined XIENCE V® EECSS acute performance and deliverability.
acute
Physician-determined procedure success
acute
Secondary Outcomes (12)
Individual component of adjunctive devices and drugs used during procedure. Number and type of guide wires
acute
Individual component of adjunctive devices and drugs used during procedure. Number and type of guiding catheters
acute
Individual component of adjunctive devices and drugs used during procedure. Number and type of balloon dilation catheters
acute
Individual component of adjunctive devices and drugs used during procedure: Balloon pressures (pre-dilation/post-dilation pressures)
acute
Individual component of adjunctive devices and drugs used during procedure: Number of stents
acute
- +7 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
All patients undergoing planned or possible PCI should be invited to participate in the study.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
The Heart Center, PC
Huntsville, Alabama, 35801, United States
Arizona Regional Medical Center
Mesa, Arizona, 85206, United States
Tri Lakes Research-Central Arkansas Cardiovascular
Hot Springs, Arkansas, 71913, United States
Tri Lakes Research-Central Arkansas Cardiovascular
Hot Springs Village, Arkansas, 71909, United States
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, 72401, United States
La Mesa Cardiac Center
La Mesa, California, 91942, United States
Pikes Peak Cardiology
Colorado Springs, Colorado, 80907, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Bradenton Heart Research Center
Bradenton, Florida, 34209, United States
Ocala Regional Medical Center
Ocala, Florida, 34471, United States
Harbin Clinic LLC
Rome, Georgia, 30165, United States
Sherman Hospital
Elgin, Illinois, 60120, United States
Heart Care Research Foundation
Mokena, Illinois, 60448, United States
Northern Indiana Research Alliance
Fort Wayne, Indiana, 46804, United States
Clarian Health Partners - Methodist Hospital
Indianapolis, Indiana, 46202, United States
Medical Consultants PC
Muncie, Indiana, 47303, United States
Iowa Heart Center
Des Moines, Iowa, 50314, United States
University of Iowa Hospital
Iowa City, Iowa, 52242, United States
Promise Regional Medical Center - Hutchinson
Hutchinson, Kansas, 67502, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Michigan Cardiovascular Institute
Midland, Michigan, 48670, United States
Michigan Cardio Vascular Institute at St. Mary's of MI
Saginaw, Michigan, 48601, United States
Coast Cardiovascular Consultants, P.L.L.C
Biloxi, Mississippi, 39501, United States
St. Luke's
Kansas City, Missouri, 64111, United States
St. Johns Mercy Medical Center
St Louis, Missouri, 63141, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, 08240, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
First Health Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Fairfield Cardiac Cath Lab, LLC
Fairfield, Ohio, 45014, United States
Smith Clinic
Marion, Ohio, 43302, United States
St. Anthony Hospital
Oklahoma City, Oklahoma, 73102, United States
Conemaugh Valley Memorial Hospital
Johnstown, Pennsylvania, 15905, United States
The Good Samaritan Hospital
Lebanon, Pennsylvania, 17042, United States
Phoenixville Hospital
Phoenixville, Pennsylvania, 19460, United States
University Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213, United States
UPMC Presbyterian Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
Palmetto Health Clinic
Columbia, South Carolina, 29210, United States
Piedmont Medical Center / Carolina Cardiology Associates
Rock Hill, South Carolina, 29732, United States
Wellmont Bristol Regional Medical Center
Bristol, Tennessee, 37620, United States
Tomball Regional Medical Center
Tomball, Texas, 77375, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, 23225, United States
Cardiovascular Associates, Ltd.
Virginia Beach, Virginia, 23454, United States
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia, 25304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John McPherson, MD
Vanderbuilt University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 5, 2008
First Posted
August 8, 2008
Study Start
October 1, 2008
Primary Completion
March 1, 2009
Study Completion
October 1, 2009
Last Updated
October 16, 2009
Record last verified: 2009-10