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

Coronary Artery Disease Clinical Trial

— EXCEED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731237
• Other study ID #: 08-382
• Status: Completed
• Phase: N/A
• First received: August 5, 2008
• Last updated: October 15, 2009
• Start date: October 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 2517
• Est. completion date: October 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	Coast Cardiovascular Consultants, P.L.L.C	Biloxi	Mississippi
United States	Bradenton Heart Research Center	Bradenton	Florida
United States	Wellmont Bristol Regional Medical Center	Bristol	Tennessee
United States	CAMC Health Education and Research Institute, Inc.	Charleston	West Virginia
United States	Pikes Peak Cardiology	Colorado Springs	Colorado
United States	Palmetto Health Clinic	Columbia	South Carolina
United States	Iowa Heart Center	Des Moines	Iowa
United States	Sherman Hospital	Elgin	Illinois
United States	Fairfield Cardiac Cath Lab, LLC	Fairfield	Ohio
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Northern Indiana Research Alliance	Fort Wayne	Indiana
United States	Tri Lakes Research-Central Arkansas Cardiovascular	Hot Springs National Park	Arkansas
United States	Tri Lakes Research-Central Arkansas Cardiovascular	Hot Springs Village	Arkansas
United States	The Heart Center, PC	Huntsville	Alabama
United States	Promise Regional Medical Center - Hutchinson	Hutchinson	Kansas
United States	Clarian Health Partners - Methodist Hospital	Indianapolis	Indiana
United States	University of Iowa Hospital	Iowa City	Iowa
United States	Allegiance Health	Jackson	Michigan
United States	Conemaugh Valley Memorial Hospital	Johnstown	Pennsylvania
United States	NEA Baptist Memorial Hospital	Jonesboro	Arkansas
United States	St. Luke's	Kansas City	Missouri
United States	La Mesa Cardiac Center	La Mesa	California
United States	The Good Samaritan Hospital	Lebanon	Pennsylvania
United States	Smith Clinic	Marion	Ohio
United States	Arizona Regional Medical Center	Mesa	Arizona
United States	Michigan Cardiovascular Institute	Midland	Michigan
United States	Heart Care Research Foundation	Mokena	Illinois
United States	Medical Consultants PC	Muncie	Indiana
United States	Ocala Regional Medical Center	Ocala	Florida
United States	St. Anthony Hospital	Oklahoma City	Oklahoma
United States	Phoenixville Hospital	Phoenixville	Pennsylvania
United States	First Health Moore Regional Hospital	Pinehurst	North Carolina
United States	University Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian Shadyside Hospital	Pittsburgh	Pennsylvania
United States	AtlantiCare Regional Medical Center	Pomona	New Jersey
United States	Renown Regional Medical Center	Reno	Nevada
United States	Virginia Cardiovascular Specialists	Richmond,	Virginia
United States	Piedmont Medical Center / Carolina Cardiology Associates	Rock Hill	South Carolina
United States	Harbin Clinic LLC	Rome	Georgia
United States	Michigan Cardio Vascular Institute at St. Mary's of MI	Saginaw	Michigan
United States	St. Johns Mercy Medical Center	St. Louis	Missouri
United States	Tomball Regional Medical Center	Tomball	Texas
United States	Cardiovascular Associates, Ltd.	Virginia Beach,	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall physician-determined XIENCE V® EECSS acute performance and deliverability.		acute	No
Primary	Physician-determined procedure success		acute	No
Secondary	Individual component of adjunctive devices and drugs used during procedure. Number and type of guide wires		acute	No
Secondary	Individual component of adjunctive devices and drugs used during procedure. Number and type of guiding catheters		acute	No
Secondary	Individual component of adjunctive devices and drugs used during procedure. Number and type of balloon dilation catheters		acute	No
Secondary	Individual component of adjunctive devices and drugs used during procedure: Balloon pressures (pre-dilation/post-dilation pressures)		acute	No
Secondary	Individual component of adjunctive devices and drugs used during procedure: Number of stents		acute	No
Secondary	Individual component of adjunctive devices and drugs used during procedure: Amount of radiographic contrast		acute	No
Secondary	Individual component of adjunctive devices and drugs used during procedure: Fluoroscopy time		acute	No
Secondary	Individual component of adjunctive devices and drugs used during procedure: Duration of PCI procedure		acute	No
Secondary	Individual component of adjunctive devices and drugs used during procedure: IVUS use		acute	No
Secondary	Individual component of adjunctive devices and drugs used during procedure: Thienopyridine loading dose (prior to, during or after procedure)		acute	No
Secondary	Individual component of adjunctive devices and drugs used during procedure: Aspirin loading dose (prior to, during or after procedure)		acute	No
Secondary	Device Success		acute	No