Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-28 @ 2:05 AM
Study NCT ID:
NCT01003795
Status:
WITHDRAWN
Last Update Posted:
2020-10-19
First Post:
2009-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promus - Registry Experience at the Washington Hospital Center, Drug-eluting Stent (DES)
Sponsor:
Medstar Health Research Institute
Organization:
Study Overview
Official Title:
P-REWARDS (Promus - Registry Experience at the Washington Hospital Center, DES)
Status:
WITHDRAWN
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Funded
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P-REWARDS
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: