XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery

Abbott Medical Devices43 sites in 1 country2,517 target enrollmentOctober 2008

ConditionsAtherosclerosis Coronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atherosclerosis
Sponsor: Abbott Medical Devices
Enrollment: 2517
Locations: 43
Primary Endpoint: Overall physician-determined XIENCE V® EECSS acute performance and deliverability.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

October 2009

Last Updated

16 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Eligibility Criteria

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.

Exclusion Criteria

•Inability to obtain an informed consent is an exclusion criterion.

Outcomes

Primary Outcomes

Overall physician-determined XIENCE V® EECSS acute performance and deliverability.

Time Frame: acute

Physician-determined procedure success

Time Frame: acute

Secondary Outcomes

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)