REWARDS Premier Taxus-Liberte vs Xience V | NCT02256527

Studies
REWARDS Premier Taxus-Liberte vs Xience V

NCT02256527

Sponsor

Medstar Health Research Institute

Status

Completed

Last Update Posted

Jul 14, 2016Estimated

Enrollment

917Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Observational

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Oct 1, 2014

First Submission Date that Met QC Criteria

Oct 1, 2014

First Posted Date

Oct 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2016

Last Update Posted Date

Jul 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Multicenter, retrospective registry to collect baseline, clinical, procedural, in hospital and 9-12 month follow-up data to compare major adverse cardiac events in patients receiving Promus Premier drug eluting stent to data already collected from the REWARDS-TLX Registry in which patients received either the Taxus Liberte or XIENCE V drug eluting stent.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

917Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Promus Premier		observational data	Other: Observational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	compare data	Promus Premier

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major adverse cardiac event	composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 years of age or older
Underwent PCI with Promus Premier (alone) DES

Exclusion Criteria:

Underwent PCI with a non-Promus Premier DES during the same index procedure
Patients not taking, or unable to take, dual antiplatelet therapy (aspirin plus clopidogrel, prasugrel, or ticagrelor)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients male or female, 18 years or older who have undergone percutaneous coronary intervention with Promus Premier (alone) drug eluting stent

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington Hospital Center		Washington D.C.	District of Columbia	20010	United States

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided