Promus - Registry Experience at the Washington Hospital C... | NCT01003795

Studies
Promus - Registry Experience at the Washington Hospital Center, Drug-eluting Stent (DES)

NCT01003795

Sponsor

Medstar Health Research Institute

Status

Withdrawn

Last Update Posted

Oct 19, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not Funded

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Jul 2012Actual

Completion Date

Oct 2013Actual

First Submitted Date

Oct 20, 2009

First Submission Date that Met QC Criteria

Oct 28, 2009

First Posted Date

Oct 29, 2009Estimated

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

Oct 15, 2020

Last Update Posted Date

Oct 19, 2020Actual

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

Single-center registry of patients treated with at least one Promus, everolimus-eluting, Stent, with the primary objective to assess clinical success and safety at 30 days, 6 months and 1 year post-implantation.

Detailed Description

Interventional cardiology was revolutionized by the invention of stents, initially with the bare-metal stents (BMS) and recently with the drug-eluting stents (DES). The everolimus eluting stents have shown very promising results in randomized clinical trials, demonstrating a reduction of clinical and angiographic restenosis in comparison to BMS, and comparable clinically-driven target lesion revascularization rates in comparison with sirolimus-eluting stents. While registry data is available from outside of the United States, it will be important to collect "real-world" data regarding the stent usage and outcomes in the United States. In this study we propose to follow patients who received at least one Promus® Stent for at least 1 year post initial stent implantation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Promus		Patients treated with at least one Promus, everolimus-eluting, Stent

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of Major Adverse Cardiac Events (MACE) post Promus Stent implantation		Follow up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients, male or female, >18 years of age
Patients who received at least one Promus drug-eluting stent at the Washington Hospital Center

Exclusion Criteria:

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 treated with at least one Promus, everolimus-eluting, Stent at the Washington Hospital Center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ron Waksman, MD	Medstar Research Institute/Cardiovascular Research Institute	Principal Investigator

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