XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery
This study has been completed.
Sponsor:
Abbott Vascular
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00731237
First received: August 5, 2008
Last updated: October 15, 2009
Last verified: October 2009
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Purpose
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
| Condition |
|---|
|
Atherosclerosis Coronary Artery Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery |
Resource links provided by NLM:
Further study details as provided by Abbott Vascular:
Primary Outcome Measures:
- Overall physician-determined XIENCE V® EECSS acute performance and deliverability. [ Time Frame: acute ] [ Designated as safety issue: No ]
- Physician-determined procedure success [ Time Frame: acute ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Individual component of adjunctive devices and drugs used during procedure. Number and type of guide wires [ Time Frame: acute ] [ Designated as safety issue: No ]
- Individual component of adjunctive devices and drugs used during procedure. Number and type of guiding catheters [ Time Frame: acute ] [ Designated as safety issue: No ]
- Individual component of adjunctive devices and drugs used during procedure. Number and type of balloon dilation catheters [ Time Frame: acute ] [ Designated as safety issue: No ]
- Individual component of adjunctive devices and drugs used during procedure: Balloon pressures (pre-dilation/post-dilation pressures) [ Time Frame: acute ] [ Designated as safety issue: No ]
- Individual component of adjunctive devices and drugs used during procedure: Number of stents [ Time Frame: acute ] [ Designated as safety issue: No ]
- Individual component of adjunctive devices and drugs used during procedure: Amount of radiographic contrast [ Time Frame: acute ] [ Designated as safety issue: No ]
- Individual component of adjunctive devices and drugs used during procedure: Fluoroscopy time [ Time Frame: acute ] [ Designated as safety issue: No ]
- Individual component of adjunctive devices and drugs used during procedure: Duration of PCI procedure [ Time Frame: acute ] [ Designated as safety issue: No ]
- Individual component of adjunctive devices and drugs used during procedure: IVUS use [ Time Frame: acute ] [ Designated as safety issue: No ]
- Individual component of adjunctive devices and drugs used during procedure: Thienopyridine loading dose (prior to, during or after procedure) [ Time Frame: acute ] [ Designated as safety issue: No ]
- Individual component of adjunctive devices and drugs used during procedure: Aspirin loading dose (prior to, during or after procedure) [ Time Frame: acute ] [ Designated as safety issue: No ]
- Device Success [ Time Frame: acute ] [ Designated as safety issue: No ]
| Enrollment: | 2517 |
| Study Start Date: | October 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All patients undergoing planned or possible PCI should be invited to participate in the study.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731237
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| The Heart Center, PC | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Arizona Regional Medical Center | |
| Mesa, Arizona, United States, 85206 | |
| United States, Arkansas | |
| Tri Lakes Research-Central Arkansas Cardiovascular | |
| Hot Springs National Park, Arkansas, United States, 71913 | |
| Tri Lakes Research-Central Arkansas Cardiovascular | |
| Hot Springs Village, Arkansas, United States, 71909 | |
| NEA Baptist Memorial Hospital | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| La Mesa Cardiac Center | |
| La Mesa, California, United States, 91942 | |
| United States, Colorado | |
| Pikes Peak Cardiology | |
| Colorado Springs, Colorado, United States, 80907 | |
| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
| United States, Florida | |
| Bradenton Heart Research Center | |
| Bradenton, Florida, United States, 34209 | |
| Ocala Regional Medical Center | |
| Ocala, Florida, United States, 34471 | |
| United States, Georgia | |
| Harbin Clinic LLC | |
| Rome, Georgia, United States, 30165 | |
| United States, Illinois | |
| Sherman Hospital | |
| Elgin, Illinois, United States, 60120 | |
| Heart Care Research Foundation | |
| Mokena, Illinois, United States, 60448 | |
| United States, Indiana | |
| Northern Indiana Research Alliance | |
| Fort Wayne, Indiana, United States, 46804 | |
| Clarian Health Partners - Methodist Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| Medical Consultants PC | |
| Muncie, Indiana, United States, 47303 | |
| United States, Iowa | |
| Iowa Heart Center | |
| Des Moines, Iowa, United States, 50314 | |
| University of Iowa Hospital | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Promise Regional Medical Center - Hutchinson | |
| Hutchinson, Kansas, United States, 67502 | |
| United States, Michigan | |
| Allegiance Health | |
| Jackson, Michigan, United States, 49201 | |
| Michigan Cardiovascular Institute | |
| Midland, Michigan, United States, 48670 | |
| Michigan Cardio Vascular Institute at St. Mary's of MI | |
| Saginaw, Michigan, United States, 48601 | |
| United States, Mississippi | |
| Coast Cardiovascular Consultants, P.L.L.C | |
| Biloxi, Mississippi, United States, 39501 | |
| United States, Missouri | |
| St. Luke's | |
| Kansas City, Missouri, United States, 64111 | |
| St. Johns Mercy Medical Center | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nevada | |
| Renown Regional Medical Center | |
| Reno, Nevada, United States, 89502 | |
| United States, New Jersey | |
| AtlantiCare Regional Medical Center | |
| Pomona, New Jersey, United States, 08240 | |
| United States, New Mexico | |
| University of New Mexico Health Sciences Center | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, North Carolina | |
| First Health Moore Regional Hospital | |
| Pinehurst, North Carolina, United States, 28374 | |
| United States, Ohio | |
| Fairfield Cardiac Cath Lab, LLC | |
| Fairfield, Ohio, United States, 45014 | |
| Smith Clinic | |
| Marion, Ohio, United States, 43302 | |
| United States, Oklahoma | |
| St. Anthony Hospital | |
| Oklahoma City, Oklahoma, United States, 73102 | |
| United States, Pennsylvania | |
| Conemaugh Valley Memorial Hospital | |
| Johnstown, Pennsylvania, United States, 15905 | |
| The Good Samaritan Hospital | |
| Lebanon, Pennsylvania, United States, 17042 | |
| Phoenixville Hospital | |
| Phoenixville, Pennsylvania, United States, 19460 | |
| University Pittsburgh Medical Center (UPMC) | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| UPMC Presbyterian Shadyside Hospital | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, South Carolina | |
| Palmetto Health Clinic | |
| Columbia, South Carolina, United States, 29210 | |
| Piedmont Medical Center / Carolina Cardiology Associates | |
| Rock Hill, South Carolina, United States, 29732 | |
| United States, Tennessee | |
| Wellmont Bristol Regional Medical Center | |
| Bristol, Tennessee, United States, 37620 | |
| United States, Texas | |
| Tomball Regional Medical Center | |
| Tomball, Texas, United States, 77375 | |
| United States, Virginia | |
| Virginia Cardiovascular Specialists | |
| Richmond,, Virginia, United States, 23225 | |
| Cardiovascular Associates, Ltd. | |
| Virginia Beach,, Virginia, United States, 23454 | |
| United States, West Virginia | |
| CAMC Health Education and Research Institute, Inc. | |
| Charleston, West Virginia, United States, 25304 | |
Sponsors and Collaborators
Abbott Vascular
Investigators
| Principal Investigator: | John McPherson, MD | Vanderbuilt University |
More Information
No publications provided
| Responsible Party: | Matt Kiely, Manager Medical Information, Abbott Vascular |
| ClinicalTrials.gov Identifier: | NCT00731237 History of Changes |
| Other Study ID Numbers: | 08-382 |
| Study First Received: | August 5, 2008 |
| Last Updated: | October 15, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Abbott Vascular:
|
Drug Eluting Stent Percutaneous Coronary Intervention Everolimus |
Additional relevant MeSH terms:
|
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Cardiovascular Diseases Heart Diseases Everolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013