Stent ThrombosisFRISTNCT00905008
Long-Term Safety of Drug Eluting Stents in the "Real World" (FReIburger STent Registry)
An observational study of Stent Thrombosis, run by University Hospital Freiburg.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stent Thrombosis
- What is being tested?
- transluminal percutaneous coronary intervention and Drug-Eluting and Bare-Metal stents
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 1,502 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Consecutive patients undergoing percutaneous coronary intervention
Who cannot join
- Patient refusal or inability to provide written informed consent
About this study
Official title: Long-Term Safety and Efficacy of Drug Eluting Stents in "Real World" - Results From the FReIburger STent Registry
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
- Being tested
- transluminal percutaneous coronary intervention, Drug-Eluting and Bare-Metal stents
- Keywords
- drug-eluting stent, bare-metal stent, long-term safety, mortality, stent thrombosis, Angioplasty, Transluminal, Percutaneous Coronary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transluminal percutaneous coronary interventionProcedure or surgery
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.
Drug-Eluting and Bare-Metal stentsDevice
Sirolimus-eluting stents (Cypher®), Paclitaxel-eluting stents (Taxus®) Zotarolimus-eluting stents (Endeavor®) and uncoated (bare-metal) stents
| Study group | Role | What they receive |
|---|---|---|
| DES | Patients underwent percutaneous coronary intervention and received at least one drug-eluting stent during their index hospitalisation. Receives: Procedure: transluminal percutaneous coronary intervention; Device: Drug-Eluting and Bare-Metal stents | |
| BMS | Patients underwent percutaneous coronary intervention and received at least one uncoated stent during their index hospitalisation. Receives: Procedure: transluminal percutaneous coronary intervention; Device: Drug-Eluting and Bare-Metal stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality (cardiac- and non-cardiac death).
Measured: 5 years
Secondary outcomes (2)
The composite of death and MI and stent thrombosis.
Measured: 5 years
The occurrence of TVR, stroke, major bleeding, sepsis and tumor were also assessed.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startOct 2006
- Primary completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stent ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Thorsten Grumann, MD, Principal investigator, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905008
- Sponsor's protocol ID
- FRIST_GH0102
- Acronym
- FRIST
- Status last verified
- May 2009
- First submitted
- 15 May 2009
- Last updated
- 20 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kersting S, Grumann T, Hummel J, Hauschke D, Bode C, Hehrlein C. Impact of chronic kidney disease on long-term clinical outcomes after percutaneous coronary intervention with drug-eluting or bare-metal stents. Crit Pathw Cardiol. 2012 Sep;11(3):152-9. doi: 10.1097/HPC.0b013e31825d267a.
PubMed 22825536
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Safety and Efficacy of Drug Eluting Stents in "Real World" - Results From the FReIburger STent Registry
- ClinicalTrials.gov ID
- NCT00905008
- Acronym / sponsor ID
- FRIST / FRIST_GH0102
- Conditions
- Stent Thrombosis
- Keywords
- drug-eluting stent, bare-metal stent, long-term safety, mortality, stent thrombosis, Angioplasty, Transluminal, Percutaneous Coronary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,502 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- May 2009 (estimated)
- First posted
- 20 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DES | – | Procedure: transluminal percutaneous coronary intervention, Device: Drug-Eluting and Bare-Metal stentsPatients underwent percutaneous coronary intervention and received at least one drug-eluting stent during their index hospitalisation. |
| BMS | – | Procedure: transluminal percutaneous coronary intervention, Device: Drug-Eluting and Bare-Metal stentsPatients underwent percutaneous coronary intervention and received at least one uncoated stent during their index hospitalisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Consecutive patients undergoing percutaneous coronary intervention
Key exclusion criteria (1 listed)
- Patient refusal or inability to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transluminal percutaneous coronary interventionAll 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. | Procedure or surgery | BMS, DES |
| Drug-Eluting and Bare-Metal stentsSirolimus-eluting stents (Cypher®), Paclitaxel-eluting stents (Taxus®) Zotarolimus-eluting stents (Endeavor®) and uncoated (bare-metal) stents | Device | BMS, DES |
Primary outcome
All cause mortality (cardiac- and non-cardiac death).
Time frame: 5 years
2 secondary outcomes
The composite of death and MI and stent thrombosis.
Time frame: 5 years
The occurrence of TVR, stroke, major bleeding, sepsis and tumor were also assessed.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2009.
- Derived from this study: PubMed 22825536Kersting S, Grumann T, Hummel J, Hauschke D, Bode C, Hehrlein C. Impact of chronic kidney disease on long-term clinical outcomes after percutaneous coronary intervention with drug-eluting or bare-metal stents. Crit Pathw Cardiol. 2012 Sep;11(3):152-9. doi: 10.1097/HPC.0b013e31825d267a.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten Grumann, MD principal investigator
University of Freiburg
Questions about this trial
What is this clinical trial studying?
An observational study of Stent Thrombosis, run by University Hospital Freiburg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (cardiac- and non-cardiac death). (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00905008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2009.