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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00731237

Acronym

EXCEED

Enrollment

2517

Registered

2008-08-08

Start date

2008-10-31

Completion date

2009-10-31

Last updated

2009-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Coronary Artery Disease

Keywords

Drug Eluting Stent, Percutaneous Coronary Intervention, Everolimus

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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. Number and type of guide wires	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
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. Number and type of guiding catheters	acute

Countries

United States

Outcome results