Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01003795

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

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

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
Medstar Health Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2009-10-01
Primary completion
2012-07-01
Completion
2013-10-01
First posted
2009-10-29
Last updated
2020-10-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01003795. Inclusion in this directory is not an endorsement.