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

Coronary Artery Disease Clinical Trial

— P-REWARDS  

Official title:

P-REWARDS (Promus - Registry Experience at the Washington Hospital Center, DES)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01003795
• Other study ID #: P REWARDS
• Status: Withdrawn
• Start date: October 2009
• Est. completion date: October 2013

Study information

• Verified date: October 2020
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• N/A

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Major Adverse Cardiac Events (MACE) post Promus Stent implantation		Follow up