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XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort (XVU-AV DAPT)

Primary Purpose

Chronic Total Occlusion of Coronary Artery, Vascular Disease, Myocardial Ischemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
placebo + aspirin
clopidogrel + aspirin OR prasugrel + aspirin
XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Total Occlusion of Coronary Artery focused on measuring drug eluting stents, Stents, Angioplasty, Stent thrombosis, antiplatelet treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are enrolled into the XIENCE V USA Study Phase I
  • The patient agrees to participate in this study by signing the Institutional Review Board (IRB) approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.

Exclusion Criteria:

  • The inability to obtain an informed consent is an exclusion criterion.

Patients must meet the following criteria to be eligible for randomization in the study:

  • Patient is "12 Month Clear": "12-Month Clear" patients are free from death, MI, stroke, repeat coronary revascularization, major bleeding - "severe" or "moderate" by GUSTO classification, and ST 12 months after stent implantation. Staged PCI is allowed (same stent type as index); repeat PCI and peri-procedural myocardial infarction occurring with the index procedure or repeat procedure within the first 6 weeks will not be considered exclusionary events for the definition of "12 Month Clear".
  • Patient is "DAPT Compliant": During the open label portion of this study (time 0-12 months), a patient is considered compliant with the thienopyridine therapy for the purposes of eligibility if they take between 80% and 120% of the prescribed drug in a given period without an interruption of therapy longer than 14 days. This information will be ascertained via data collected at the patient interviews at 6 and 12 months post-procedure. Compliance at both time points is required to be considered "clear".
  • Patient completes 1 year visit within ± 30 days window.

Patients will be excluded from randomization if any of the following criteria are met:

  • Pregnant women.
  • Switched thienopyridine type or dose within 6 months prior to randomization. Note: Thienopyridine switching during the open label portion of this study is discouraged.
  • PCI or cardiac surgery between 6 weeks post index procedure and randomization.
  • Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
  • Current medical condition with a life expectancy of less than 3 years.
  • Patients on warfarin or similar anticoagulant therapy.

Sites / Locations

  • Birmingham Heart Clinic, PC
  • Thomas Hospital
  • Scottsdale Healthcare
  • Arkansas Heart Hospital
  • California Cardiovascular Consultants
  • FACT/ Los Angeles Cardiology
  • University of Southern California
  • Eisenhower Medical Center, Desert Cardiology Center
  • Regional Cardiology Associates
  • Salinas Valley Memorial Healthcare System
  • Sansum Clinic
  • Torrance Memorial Medical Center
  • The Medical Center of Aurora
  • St. Anthony's Central Hospital
  • St. Vincent's Medical Center
  • Washington Hospital Center
  • Brandon Regional Hospital
  • Morton Plant Hospital
  • Memorial Regional Hospital
  • Sacred Heart Hospital
  • Sarasota Memorial Hospital
  • Cardiology Partners Clinical Research Institute (Formerly Palm Beach Gardens Medical Center)
  • Piedmont Hospital
  • Saint Joseph's Hospital of Atlanta
  • University Hospital Augusta Cardiology Clinic
  • NE Georgia Medical Center
  • WellStar Kennestone Hospital
  • Midwest Heart Foundation
  • Heart Care Midwest (OSF/St Francis)
  • St. John's Hospital / Prairie Education & Research Cooperative
  • Elkhart Midwest Cardiovascular Research & Education Foundation
  • The Care Group at Methodist
  • St. Francis Hospital and Health Centers
  • Indiana Heart Hospital
  • Cotton O'Neil Clinical Research Center
  • Galichia Heart Hospital
  • Central Baptist Hospital
  • Northeast Cardiology Associates
  • Maine Cardiology Associates
  • Union Memorial Hospital
  • Johns Hopkins Hospital
  • Peninsula Regional Medical Center
  • Washington Adventist Hospital
  • St. Joseph Medical Center
  • Boston Medical Center East
  • Lahey Clinic
  • Baystate Medical Center
  • UMass Memorial Medical Center
  • Oakwood Hospital and Medical Center
  • St John Hospital & Medical Center
  • Sparrow Hospital
  • Northern Michigan Hospital
  • St. Joseph Mercy Oakland Hospital
  • William Beaumont Hospital
  • Michigan Cardio Vascular Institute at St. Mary's of MI
  • Covenant Medical Center, INC.
  • Lakeland Hospital St. Joseph
  • St. Joseph Mercy Hospital
  • North Memorial Medical Center
  • Mercy Hospital
  • St. Paul Heart Clinic
  • Southern Heart Center
  • Jackson Heart Clinic
  • St. Luke's Hospital
  • North Kansas City Hospital
  • St. John's Research Institute, Inc., St. John's Hospital
  • Barnes Jewish Hospital
  • Billings Clinic Research Center
  • Dartmouth Hitchock Medical Center
  • Englewood Hospital & Medical Center
  • Hackensack Medical Center
  • CADV
  • St. Joseph's Regional Medical Center
  • The Valley Hospital
  • St. Peters Hospital
  • Jack D. Weiler Hospital of Montefiore Medical Center
  • Buffalo Heart group
  • Mount Sinai Medical Center
  • Rochester Cardiopulmonary Group
  • Stony Brook Hospital and Medical Center
  • St. Joseph's Hospital Health Center
  • University of North Carolina
  • Carolinas Medical Center
  • Mid Carolina Cardiology
  • Duke University Medical Center
  • Gaston Memorial Hospital
  • High Point Regional Health System
  • WakeMed Hospital
  • Forsyth Medical Center
  • Wake Forest University Baptist Medical Center
  • Altru Health System
  • The Christ Hospital
  • University of Cincinnati Medical Center
  • North Ohio Research LTD, Elyria Regional Medical Center
  • Fairview Hospital
  • The Toledo Hospital-Jobst Vascular Center
  • St. Vincent Mercy Medical Center
  • Cardiology Associates of Southeastern Ohio, Inc
  • Midwest Regional Medical Center
  • The University of Oklahoma Health Sciences Center
  • Integris Baptist Medical, Inc.
  • Hillcrest Medical Center
  • Sacred Heart Medical Center
  • Abington Memorial Hospital
  • Tri-State Medical Group
  • Bryn Mawr Hospital
  • Franklin County Heart Center at Summit Cardiology
  • Geisinger Medical Center
  • Doylestown Hospital
  • Harrisburg Hospital / Pinnacle Health
  • Lancaster Heart & Stroke Foundation
  • Hahnemann Hospital
  • Penn Presbyterian Medical Center
  • The Western Pennsylvania Hospital
  • Holy Spirit Hospital
  • Main Line Health Heart Center/The Lankenau Hospital
  • York Hospital
  • The Miriam Hospital
  • AnMed Health
  • Providence Hospital-SC
  • Sanford USD Medical Center
  • Memorial Health System
  • West Clinic d/b/a Memphis Heart Clinic
  • Centennial Heart Cardiovascular Consultants, LLC.
  • St. Thomas Hospital
  • Vanderbilt Vniversity Medical Center
  • Amarillo Heart Clinical Research Institute
  • Capital Cadiovascular Specialists
  • Baylor Heart and Vascular Hospital
  • The Methodist Hospital
  • Lubbock Heart Hospital
  • Permian Research Foundation
  • South Texas Methodist Hospital
  • Intermountain Medical Center
  • University of Virginia Health System
  • Virginia Cardiovascular Consultants
  • Sentara Norfolk General Hospital
  • Carilion Roanoke Memorial
  • Overlake Hospital Medical Center
  • Providence Everett Medical Center
  • St. Joseph's Tacoma
  • St Mary's Medical Hospital
  • Aurora St. Luke's Medical Center
  • Wisconsin Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

12 month DAPT arm

30 month DAPT arm

Arm Description

placebo + aspirin

clopidogrel + aspirin OR prasugrel + aspirin

Outcomes

Primary Outcome Measures

Incidence of Composite of All Death, MI and Stroke (Defined as MACE)
Incidence of ARC Definite or Probable ST
Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)

Secondary Outcome Measures

MACE for ITT Population
ST for ITT Population
Major Bleeding for ITT Population
MACE for Treatment Population
ST for Treatment Population
Major Bleeding for Treatment Population

Full Information

First Posted
April 16, 2010
Last Updated
May 12, 2016
Sponsor
Abbott Medical Devices
Collaborators
Baim Institute for Clinical Research, Bristol-Myers Squibb, Eli Lilly and Company, Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01106534
Brief Title
XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
Acronym
XVU-AV DAPT
Official Title
XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
Collaborators
Baim Institute for Clinical Research, Bristol-Myers Squibb, Eli Lilly and Company, Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives of this study are To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.
Detailed Description
This prospective, multi-center, randomized, double-blind AV-DAPT study cohort is designed to collect data to support the FDA DAPT initiative. The protocol for AV-DAPT cohort is designed according to the HCRI-DAPT (NCT00977938) study protocol, Study IDE # G080186. A total 8040 patients (5034 in initial enrollment phase and additional ~3000 patients in the second enrollment phase) enrolled in the XIENCE V USA (NCT00676520) had completed Phase I and were evaluated at 1 year. These patients were transferred to the following cohorts in Phase II and followed-up for 1-5 years: The long-term follow-up cohort of phase II (NCT01120379) consisted of 5020 patients from the first enrollment phase who were not transferred to the HCRI- DAPT study and remained in the study beyond 1 year. Patients from the additional 3000 treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular. The remaining patients from the additional 3000 patients who did not participate in AV-DAPT cohort will be followed for the first year only. A study completion form will be filled out and the patients will not be followed beyond their 1 year visit. The participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Total Occlusion of Coronary Artery, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
Keywords
drug eluting stents, Stents, Angioplasty, Stent thrombosis, antiplatelet treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
870 (Actual)

8. Arms, Groups, and Interventions

Arm Title
12 month DAPT arm
Arm Type
Placebo Comparator
Arm Description
placebo + aspirin
Arm Title
30 month DAPT arm
Arm Type
Active Comparator
Arm Description
clopidogrel + aspirin OR prasugrel + aspirin
Intervention Type
Drug
Intervention Name(s)
placebo + aspirin
Intervention Description
This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.
Intervention Type
Drug
Intervention Name(s)
clopidogrel + aspirin OR prasugrel + aspirin
Other Intervention Name(s)
Dual Antiplatelet Therapy
Intervention Description
This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.
Intervention Type
Device
Intervention Name(s)
XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
Intervention Description
XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.
Primary Outcome Measure Information:
Title
Incidence of Composite of All Death, MI and Stroke (Defined as MACE)
Time Frame
12-33 months post-stent
Title
Incidence of ARC Definite or Probable ST
Time Frame
12-33 months post-stent
Title
Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)
Time Frame
12-33 months post-stent
Secondary Outcome Measure Information:
Title
MACE for ITT Population
Time Frame
12 through 30 months
Title
ST for ITT Population
Time Frame
12 through 30 months
Title
Major Bleeding for ITT Population
Time Frame
12 through 30 months
Title
MACE for Treatment Population
Time Frame
12 through 30 months and 12 through 33 months
Title
ST for Treatment Population
Time Frame
12 through 30 months and 12 through 33 months
Title
Major Bleeding for Treatment Population
Time Frame
12 through 30 months and 12 through 33 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are enrolled into the XIENCE V USA Study Phase I The patient agrees to participate in this study by signing the Institutional Review Board (IRB) approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form. Exclusion Criteria: The inability to obtain an informed consent is an exclusion criterion. Patients must meet the following criteria to be eligible for randomization in the study: Patient is "12 Month Clear": "12-Month Clear" patients are free from death, MI, stroke, repeat coronary revascularization, major bleeding - "severe" or "moderate" by GUSTO classification, and ST 12 months after stent implantation. Staged PCI is allowed (same stent type as index); repeat PCI and peri-procedural myocardial infarction occurring with the index procedure or repeat procedure within the first 6 weeks will not be considered exclusionary events for the definition of "12 Month Clear". Patient is "DAPT Compliant": During the open label portion of this study (time 0-12 months), a patient is considered compliant with the thienopyridine therapy for the purposes of eligibility if they take between 80% and 120% of the prescribed drug in a given period without an interruption of therapy longer than 14 days. This information will be ascertained via data collected at the patient interviews at 6 and 12 months post-procedure. Compliance at both time points is required to be considered "clear". Patient completes 1 year visit within ± 30 days window. Patients will be excluded from randomization if any of the following criteria are met: Pregnant women. Switched thienopyridine type or dose within 6 months prior to randomization. Note: Thienopyridine switching during the open label portion of this study is discouraged. PCI or cardiac surgery between 6 weeks post index procedure and randomization. Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization. Current medical condition with a life expectancy of less than 3 years. Patients on warfarin or similar anticoagulant therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Hermiller, MD
Organizational Affiliation
Heart Center of Indianapolis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mitch Krucoff, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham Heart Clinic, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Thomas Hospital
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
California Cardiovascular Consultants
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
FACT/ Los Angeles Cardiology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Eisenhower Medical Center, Desert Cardiology Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Regional Cardiology Associates
City
Sacremento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Salinas Valley Memorial Healthcare System
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Torrance Memorial Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
The Medical Center of Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
St. Anthony's Central Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
St. Vincent's Medical Center
City
Norwalk,
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Brandon Regional Hospital
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Sacred Heart Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504-8721
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Cardiology Partners Clinical Research Institute (Formerly Palm Beach Gardens Medical Center)
City
Wellington
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Saint Joseph's Hospital of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
University Hospital Augusta Cardiology Clinic
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
NE Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
WellStar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Midwest Heart Foundation
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Heart Care Midwest (OSF/St Francis)
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
St. John's Hospital / Prairie Education & Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Facility Name
Elkhart Midwest Cardiovascular Research & Education Foundation
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
The Care Group at Methodist
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Francis Hospital and Health Centers
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Indiana Heart Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Cotton O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
Galichia Heart Hospital
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67220
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Northeast Cardiology Associates
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Maine Cardiology Associates
City
South Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Facility Name
Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Peninsula Regional Medical Center
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Facility Name
Washington Adventist Hospital
City
Tacoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
St. Joseph Medical Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Boston Medical Center East
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
St John Hospital & Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Sparrow Hospital
City
Lansing,
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
St. Joseph Mercy Oakland Hospital
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Michigan Cardio Vascular Institute at St. Mary's of MI
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Covenant Medical Center, INC.
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Lakeland Hospital St. Joseph
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
North Memorial Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Mercy Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
St. Paul Heart Clinic
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Southern Heart Center
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Jackson Heart Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
North Kansas City Hospital
City
North Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
St. John's Research Institute, Inc., St. John's Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Barnes Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Billings Clinic Research Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Dartmouth Hitchock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Englewood Hospital & Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Hackensack Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
CADV
City
Haddon Heights,
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Facility Name
St. Joseph's Regional Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
St. Peters Hospital
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Jack D. Weiler Hospital of Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Buffalo Heart group
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Mount Sinai Medical Center
City
NY
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Rochester Cardiopulmonary Group
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Stony Brook Hospital and Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
St. Joseph's Hospital Health Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13203
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Mid Carolina Cardiology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Gaston Memorial Hospital
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
High Point Regional Health System
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
WakeMed Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Altru Health System
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
North Ohio Research LTD, Elyria Regional Medical Center
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Fairview Hospital
City
Fairview Park
State/Province
Ohio
ZIP/Postal Code
44126
Country
United States
Facility Name
The Toledo Hospital-Jobst Vascular Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
St. Vincent Mercy Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Cardiology Associates of Southeastern Ohio, Inc
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Midwest Regional Medical Center
City
Midwest City
State/Province
Oklahoma
ZIP/Postal Code
73110
Country
United States
Facility Name
The University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Integris Baptist Medical, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Hillcrest Medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Sacred Heart Medical Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Tri-State Medical Group
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr,
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Franklin County Heart Center at Summit Cardiology
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Harrisburg Hospital / Pinnacle Health
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Lancaster Heart & Stroke Foundation
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17603
Country
United States
Facility Name
Hahnemann Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Holy Spirit Hospital
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Main Line Health Heart Center/The Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
AnMed Health
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Providence Hospital-SC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Memorial Health System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
West Clinic d/b/a Memphis Heart Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Centennial Heart Cardiovascular Consultants, LLC.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
St. Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt Vniversity Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Amarillo Heart Clinical Research Institute
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Capital Cadiovascular Specialists
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Baylor Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Lubbock Heart Hospital
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79416
Country
United States
Facility Name
Permian Research Foundation
City
Odessa
State/Province
Texas
ZIP/Postal Code
79761
Country
United States
Facility Name
South Texas Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Cardiovascular Consultants
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Carilion Roanoke Memorial
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Overlake Hospital Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Providence Everett Medical Center
City
Everett
State/Province
Washington
ZIP/Postal Code
98206
Country
United States
Facility Name
St. Joseph's Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
St Mary's Medical Hospital
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Wisconsin Heart Hospital
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort

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