Trials / Withdrawn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- Withdrawn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.