NCT00905008

Long-Term Safety of Drug Eluting Stents in the "Real World" (FReIburger STent Registry)

Long-Term Safety and Efficacy of Drug Eluting Stents in "Real World" - Results From the FReIburger STent Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,502 (actual)
• Sponsor: University Hospital Freiburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The FReIburger STent Registry (FRIST) is designed to determine the long term safety and efficacy of Drug Eluting Stents (DES) in a "real-world" patient population requiring stent implantation. FRIST included patients treated with DES and bare-metal stents (BMS) in the University Hospital of Freiburg, Germany, according to a non-restrictive inclusion criterion, in which virtually all consecutive patient subsets were considered eligible.

Conditions

• Stent Thrombosis

Interventions

Type	Name	Description
PROCEDURE	transluminal percutaneous coronary intervention	All interventions were done according to current practice guidelines. The operator was responsible for the decision to choose a specific treatment strategy. Angiographic success was defined as residual stenosis \<30% by visual analysis in the presence of TIMI 3 flow grade. The patients were prescribed aspirin plus clopidogrel 75 mg per day, after a loading dose of 300 mg or 600 mg, before or during the index coronary intervention. After procedure, all patients were advised to maintain lifelong use of aspirin. The use of clopidogrel (75 mg per day) was always adapted according to guideline recommendations. Heparin was infused throughout the procedure to maintain an activated clotting time of at least 250 sec. The administration of platelet glycoprotein IIb/IIIa receptor blocker was encouraged, unless in existing contraindications.
DEVICE	Drug-Eluting and Bare-Metal stents	Sirolimus-eluting stents (Cypher®), Paclitaxel-eluting stents (Taxus®) Zotarolimus-eluting stents (Endeavor®) and uncoated (bare-metal) stents

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-05-01
• First posted: 2009-05-20
• Last updated: 2009-05-20