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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Atherosclerosis

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.

• Study Type: Observational
• Enrollment (Actual): 2517

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • The Heart Center, PC
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Arizona Regional Medical Center
  • Arkansas
    • Hot Springs National Park, Arkansas, United States, 71913
      • Tri Lakes Research-Central Arkansas Cardiovascular
    • Hot Springs Village, Arkansas, United States, 71909
      • Tri Lakes Research-Central Arkansas Cardiovascular
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Memorial Hospital
  • California
    • La Mesa, California, United States, 91942
      • La Mesa Cardiac Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Pikes Peak Cardiology
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center
  • Florida
    • Bradenton, Florida, United States, 34209
      • Bradenton Heart Research Center
    • Ocala, Florida, United States, 34471
      • Ocala Regional Medical Center
  • Georgia
    • Rome, Georgia, United States, 30165
      • Harbin Clinic LLC
  • Illinois
    • Elgin, Illinois, United States, 60120
      • Sherman Hospital
    • Mokena, Illinois, United States, 60448
      • Heart Care Research Foundation
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Northern Indiana Research Alliance
    • Indianapolis, Indiana, United States, 46202
      • Clarian Health Partners - Methodist Hospital
    • Muncie, Indiana, United States, 47303
      • Medical Consultants PC
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Iowa Heart Center
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital
  • Kansas
    • Hutchinson, Kansas, United States, 67502
      • Promise Regional Medical Center - Hutchinson
  • Michigan
    • Jackson, Michigan, United States, 49201
      • Allegiance Health
    • Midland, Michigan, United States, 48670
      • Michigan Cardiovascular Institute
    • Saginaw, Michigan, United States, 48601
      • Michigan Cardio Vascular Institute at St. Mary's of MI
  • Mississippi
    • Biloxi, Mississippi, United States, 39501
      • Coast Cardiovascular Consultants, P.L.L.C
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's
    • St. Louis, Missouri, United States, 63141
      • St. Johns Mercy Medical Center
  • Nevada
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center
  • New Jersey
    • Pomona, New Jersey, United States, 08240
      • AtlantiCare Regional Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Health Sciences Center
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • First Health Moore Regional Hospital
  • Ohio
    • Fairfield, Ohio, United States, 45014
      • Fairfield Cardiac Cath Lab, Llc
    • Marion, Ohio, United States, 43302
      • Smith Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • St. Anthony Hospital
  • Pennsylvania
    • Johnstown, Pennsylvania, United States, 15905
      • Conemaugh Valley Memorial Hospital
    • Lebanon, Pennsylvania, United States, 17042
      • The Good Samaritan Hospital
    • Phoenixville, Pennsylvania, United States, 19460
      • Phoenixville Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University Pittsburgh Medical Center (UPMC)
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Presbyterian Shadyside Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29210
      • Palmetto Health Clinic
    • Rock Hill, South Carolina, United States, 29732
      • Piedmont Medical Center / Carolina Cardiology Associates
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Wellmont Bristol Regional Medical Center
  • Texas
    • Tomball, Texas, United States, 77375
      • Tomball Regional Medical Center
  • Virginia
    • Richmond,, Virginia, United States, 23225
      • Virginia Cardiovascular Specialists
    • Virginia Beach,, Virginia, United States, 23454
      • Cardiovascular Associates, Ltd.
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Health Education and Research Institute, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing planned or possible PCI should be invited to participate in the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall physician-determined XIENCE V® EECSS acute performance and deliverability.	acute
Physician-determined procedure success	acute

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: John McPherson, MD, Vanderbuilt University

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: August 5, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (Estimate): August 8, 2008

Study Record Updates

• Last Update Posted (Estimate): October 16, 2009
• Last Update Submitted That Met QC Criteria: October 15, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Everolimus; Drug Eluting Stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Atherosclerosis
• Other Study ID Numbers: 08-382