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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University Hospital Freiburg.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00905008
First received: May 15, 2009
Last updated: May 19, 2009
Last verified: May 2009
  Purpose

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 Intervention
Stent Thrombosis
Procedure: transluminal percutaneous coronary intervention
Device: Drug-Eluting and Bare-Metal stents

Study Type: Observational
Study Design: 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

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • All cause mortality (cardiac- and non-cardiac death). [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The composite of death and MI and stent thrombosis. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • The occurrence of TVR, stroke, major bleeding, sepsis and tumor were also assessed. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 1502
Study Start Date: October 2006
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905008

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

No publications provided by University Hospital Freiburg

Additional 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
Study First Received: May 15, 2009
Last Updated: May 19, 2009
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 24, 2014