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

Stent Thrombosis Clinical Trial

— FRIST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00905008
• Other study ID #: FRIST_GH0102
• Status: Active, not recruiting
• Phase: N/A
• First received: May 15, 2009
• Last updated: May 19, 2009
• Start date: October 2006

Study information

• Verified date: May 2009
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1502
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive patients undergoing percutaneous coronary intervention

Exclusion Criteria:

• Patient refusal or inability to provide written informed consent

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Stent Thrombosis
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality (cardiac- and non-cardiac death).		5 years	Yes
Secondary	The composite of death and MI and stent thrombosis.		5 years	Yes
Secondary	The occurrence of TVR, stroke, major bleeding, sepsis and tumor were also assessed.		5 years	Yes