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XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery

Completed
Conditions
Atherosclerosis
Coronary 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
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall physician-determined XIENCE V® EECSS acute performance and deliverability.acute
Physician-determined procedure successacute
Secondary Outcome Measures
NameTimeMethod
Individual component of adjunctive devices and drugs used during procedure. Number and type of guide wiresacute
Individual component of adjunctive devices and drugs used during procedure. Number and type of guiding cathetersacute
Individual component of adjunctive devices and drugs used during procedure. Number and type of balloon dilation cathetersacute
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 stentsacute
Individual component of adjunctive devices and drugs used during procedure: Amount of radiographic contrastacute
Individual component of adjunctive devices and drugs used during procedure: Fluoroscopy timeacute
Individual component of adjunctive devices and drugs used during procedure: Duration of PCI procedureacute
Individual component of adjunctive devices and drugs used during procedure: IVUS useacute
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 Successacute

Trial Locations

Locations (43)

The Heart Center, PC

🇺🇸

Huntsville, Alabama, United States

Arizona Regional Medical Center

🇺🇸

Mesa, Arizona, United States

Tri Lakes Research-Central Arkansas Cardiovascular

🇺🇸

Hot Springs Village, Arkansas, United States

NEA Baptist Memorial Hospital

🇺🇸

Jonesboro, Arkansas, United States

La Mesa Cardiac Center

🇺🇸

La Mesa, California, United States

Pikes Peak Cardiology

🇺🇸

Colorado Springs, Colorado, United States

University of Connecticut Health Center

🇺🇸

Farmington, Connecticut, United States

Bradenton Heart Research Center

🇺🇸

Bradenton, Florida, United States

Ocala Regional Medical Center

🇺🇸

Ocala, Florida, United States

Harbin Clinic LLC

🇺🇸

Rome, Georgia, United States

Scroll for more (33 remaining)
The Heart Center, PC
🇺🇸Huntsville, Alabama, United States

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