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

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ClinicalTrials.gov Identifier: NCT00905008
Recruitment Status : Unknown
Verified May 2009 by University Hospital Freiburg.
Recruitment status was:  Active, not recruiting
First Posted : May 20, 2009
Last Update Posted : May 20, 2009
Sponsor:
Information provided by:
University Hospital Freiburg

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.


Condition or disease Intervention/treatment
Stent Thrombosis Procedure: transluminal percutaneous coronary intervention Device: Drug-Eluting and Bare-Metal stents

Study Type : Observational
Actual Enrollment : 1502 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Long-Term Safety and Efficacy of Drug Eluting Stents in "Real World" - Results From the FReIburger STent Registry
Study Start Date : October 2006
Estimated Primary Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
U.S. FDA Resources

Group/Cohort Intervention/treatment
DES
Patients underwent percutaneous coronary intervention and received at least one drug-eluting stent during their index hospitalisation.
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
BMS
Patients underwent percutaneous coronary intervention and received at least one uncoated stent during their index hospitalisation.
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



Primary Outcome Measures :
  1. All cause mortality (cardiac- and non-cardiac death). [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. The composite of death and MI and stent thrombosis. [ Time Frame: 5 years ]
  2. The occurrence of TVR, stroke, major bleeding, sepsis and tumor were also assessed. [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
FRIST (FReIburger STent) is a single-centre, long-term stent registry in a high volume tertiary referral cardiovascular centre. FRIST included patients treated with drug-eluting stents and uncoated stents at the University Hospital of Freiburg, Germany, according to non-restrictive inclusion criterions, in which virtually all consecutive patient subsets were considered eligible.
Criteria

Inclusion Criteria:

  • Consecutive patients undergoing percutaneous coronary intervention

Exclusion Criteria:

  • Patient refusal or inability to provide written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905008


Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Thorsten Grumann, MD University of Freiburg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Thorsten Grumann, Department of Cardiology and Angiology, University Freiburg
ClinicalTrials.gov Identifier: NCT00905008     History of Changes
Other Study ID Numbers: FRIST_GH0102
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: May 20, 2009
Last Verified: May 2009

Keywords provided by University Hospital Freiburg:
drug-eluting stent
bare-metal stent
long-term safety
mortality
stent thrombosis
Angioplasty
Transluminal
Percutaneous Coronary

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases