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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00905008

Acronym

FRIST

Enrollment

1502

Registered

2009-05-20

Start date

2006-10-31

Completion date

Unknown

Last updated

2009-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stent Thrombosis

Keywords

drug-eluting stent, bare-metal stent, long-term safety, mortality, stent thrombosis, Angioplasty, Transluminal, Percutaneous Coronary

Brief 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.

Interventions

PROCEDUREtransluminal 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.

DEVICEDrug-Eluting and Bare-Metal stents

Sirolimus-eluting stents (Cypher®), Paclitaxel-eluting stents (Taxus®) Zotarolimus-eluting stents (Endeavor®) and uncoated (bare-metal) stents

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Consecutive patients undergoing percutaneous coronary intervention

Exclusion criteria

* Patient refusal or inability to provide written informed consent

Design outcomes

Primary

Measure	Time frame
All cause mortality (cardiac- and non-cardiac death).	5 years

Secondary

Measure	Time frame
The composite of death and MI and stent thrombosis.	5 years
The occurrence of TVR, stroke, major bleeding, sepsis and tumor were also assessed.	5 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026