XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery
- Conditions
- AtherosclerosisCoronary Artery Disease
- Registration Number
- NCT00731237
- Lead Sponsor
- Abbott Medical Devices
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2517
- 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
- Inability to obtain an informed consent is an exclusion criterion.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall physician-determined XIENCE V® EECSS acute performance and deliverability. acute Physician-determined procedure success acute
- Secondary Outcome Measures
Name Time Method 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 Individual component of adjunctive devices and drugs used during procedure: Amount of radiographic contrast acute Individual component of adjunctive devices and drugs used during procedure: Fluoroscopy time acute Individual component of adjunctive devices and drugs used during procedure: Duration of PCI procedure acute Individual component of adjunctive devices and drugs used during procedure: IVUS use acute Individual component of adjunctive devices and drugs used during procedure: Thienopyridine loading dose (prior to, during or after procedure) acute Individual component of adjunctive devices and drugs used during procedure: Aspirin loading dose (prior to, during or after procedure) acute Device Success acute
Trial Locations
- Locations (43)
NEA Baptist Memorial Hospital
🇺🇸Jonesboro, Arkansas, United States
University Pittsburgh Medical Center (UPMC)
🇺🇸Pittsburgh, Pennsylvania, United States
Palmetto Health Clinic
🇺🇸Columbia, South Carolina, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Ocala Regional Medical Center
🇺🇸Ocala, Florida, United States
Harbin Clinic LLC
🇺🇸Rome, Georgia, United States
Sherman Hospital
🇺🇸Elgin, Illinois, United States
Northern Indiana Research Alliance
🇺🇸Fort Wayne, Indiana, United States
Heart Care Research Foundation
🇺🇸Mokena, Illinois, United States
Smith Clinic
🇺🇸Marion, Ohio, United States
Medical Consultants PC
🇺🇸Muncie, Indiana, United States
Tomball Regional Medical Center
🇺🇸Tomball, Texas, United States
Promise Regional Medical Center - Hutchinson
🇺🇸Hutchinson, Kansas, United States
Pikes Peak Cardiology
🇺🇸Colorado Springs, Colorado, United States
St. Anthony Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Clarian Health Partners - Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Arizona Regional Medical Center
🇺🇸Mesa, Arizona, United States
The Heart Center, PC
🇺🇸Huntsville, Alabama, United States
La Mesa Cardiac Center
🇺🇸La Mesa, California, United States
Bradenton Heart Research Center
🇺🇸Bradenton, Florida, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
St. Johns Mercy Medical Center
🇺🇸St. Louis, Missouri, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
AtlantiCare Regional Medical Center
🇺🇸Pomona, New Jersey, United States
First Health Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
University of New Mexico Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
Fairfield Cardiac Cath Lab, LLC
🇺🇸Fairfield, Ohio, United States
UPMC Presbyterian Shadyside Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
The Good Samaritan Hospital
🇺🇸Lebanon, Pennsylvania, United States
Tri Lakes Research-Central Arkansas Cardiovascular
🇺🇸Hot Springs Village, Arkansas, United States
Michigan Cardiovascular Institute
🇺🇸Midland, Michigan, United States
Allegiance Health
🇺🇸Jackson, Michigan, United States
University of Iowa Hospital
🇺🇸Iowa City, Iowa, United States
Coast Cardiovascular Consultants, P.L.L.C
🇺🇸Biloxi, Mississippi, United States
Michigan Cardio Vascular Institute at St. Mary's of MI
🇺🇸Saginaw, Michigan, United States
St. Luke's
🇺🇸Kansas City, Missouri, United States
Conemaugh Valley Memorial Hospital
🇺🇸Johnstown, Pennsylvania, United States
Phoenixville Hospital
🇺🇸Phoenixville, Pennsylvania, United States
Wellmont Bristol Regional Medical Center
🇺🇸Bristol, Tennessee, United States
Virginia Cardiovascular Specialists
🇺🇸Richmond,, Virginia, United States
Piedmont Medical Center / Carolina Cardiology Associates
🇺🇸Rock Hill, South Carolina, United States
CAMC Health Education and Research Institute, Inc.
🇺🇸Charleston, West Virginia, United States
Cardiovascular Associates, Ltd.
🇺🇸Virginia Beach,, Virginia, United States