Coronary StenosisNCT00403338
The Impact of Stent Deployment Techniques on Clinical Outcomes of Patient Treated With the CYPHER® Stent (S.T.L.L.R.)
An observational study of Coronary Stenosis, run by Cordis US Corp..
Trial summary
1500 eligible patients will be treated with the commercially available CYPHER® sirolimus-eluting Bx Velocity™ stent. Patients will be followed to twelve months post-procedure, watching for patients that require a repeat procedure on the same diseased area of the coronary artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- CYPHER® Bx Velocity™ stent (sirolimus-eluting)
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Apr 2006
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients needing an intervention and receiving a CYPHER stent.
Who may be able to join
- Diagnosis of de novo stenosis in major coronary artery
- Can be treated with stents
- Candidate for bypass
Who cannot join
- Recent, severe MI
- Prior brachytherapy
- Impaired left ventricle function
- Heart transplant recipient
- Impaired renal function
- Disease in vein grafts from previous bypass
- Similar treatment within the last 30 days
About this study
Official title: Prospective Evaluation of the Impact of Stent Deployment Techniques on Clinical Outcomes of Patient Treated With the CYPHER® Stent, The e-CYPHER(SM)S.T.L.L.R., Registry [Study of Deployment Technique on Clinical Results]
1500 eligible patients will be treated with the commercially available CYPHER® sirolimus-eluting Bx Velocity™ stent. Patients will be followed to twelve months post-procedure, watching for patients that require a repeat procedure on the same diseased area of the coronary artery.
Read the detailed description
Geographical miss has been associated with treatment failures after intracoronary radiation therapy. This phenomenon, which is secondary to vascular injury outside the treated segment, was strongly correlated with the development of restenosis at the edges of the treated coronary segment. The European and Canadian SIRIUS trials (E and C-SIRIUS) randomized 350 patients with similar baseline characteristics of the US SIRIUS study. Operators used shorter post-dilatation balloons and direct stented 27% of the patients, achieving a 4.0% TLR rate and a 5.1% in-lesion binary restenosis. These somewhat superior results support the concept that refinement in deployment techniques may further improve clinical outcomes of drug-eluting stents.
- Conditions
- Coronary Stenosis
- Being tested
- CYPHER® Bx Velocity™ stent (sirolimus-eluting)
- Keywords
- myocardial ischemia, coronary disease, heart disease, Coronary Stenosis [MeSH heading: C14.280.647.250.285]
- Medical subject headings
- Coronary Stenosis, Myocardial Ischemia, Coronary Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYPHER® Bx Velocity™ stent (sirolimus-eluting)Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startDec 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary StenosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Amy Orlick, Study director, Cordis Corporation, a Johnson & Johnson Co.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403338
- Sponsor's protocol ID
- P03-6323
- Status last verified
- Oct 2009
- First submitted
- 22 Nov 2006
- Last updated
- 7 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Costa MA, Angiolillo DJ, Tannenbaum M, Driesman M, Chu A, Patterson J, Kuehl W, Battaglia J, Dabbons S, Shamoon F, Flieshman B, Niederman A, Bass TA; STLLR Investigators. Impact of stent deployment procedural factors on long-term effectiveness and safety of sirolimus-eluting stents (final results of the multicenter prospective STLLR trial). Am J Cardiol. 2008 Jun 15;101(12):1704-11. doi: 10.1016/j.amjcard.2008.02.053. Epub 2008 Apr 9.
PubMed 18549844Suzuki N, Angiolillo DJ, Tannenbaum MA, Driesman MH, Smith C, Bikkina M, Meckel CR, Morales CE, Xenopoulos NP, Coletta JE, Bezerra HG, Bass TA, Costa MA. Strategies for drug-eluting stent treatment of bifurcation coronary artery disease in the United States: insights from the e-Cypher S.T.L.L.R.trial. Catheter Cardiovasc Interv. 2009 Jun 1;73(7):890-7. doi: 10.1002/ccd.21796.
PubMed 19455662
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Impact of Stent Deployment Techniques on Clinical Outcomes of Patient Treated With the CYPHER® Stent, The e-CYPHER(SM)S.T.L.L.R., Registry [Study of Deployment Technique on Clinical Results]
- ClinicalTrials.gov ID
- NCT00403338
- Acronym / sponsor ID
- P03-6323
- Conditions
- Coronary Stenosis
- Keywords
- myocardial ischemia, coronary disease, heart disease, Coronary Stenosis [MeSH heading: C14.280.647.250.285]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Apr 2006 (actual)
- First posted
- 23 Nov 2006 (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.
1500 eligible patients will be treated with the commercially available CYPHER® sirolimus-eluting Bx Velocity™ stent. Patients will be followed to twelve months post-procedure, watching for patients that require a repeat procedure on the same diseased area of the coronary artery.
Detailed description
Geographical miss has been associated with treatment failures after intracoronary radiation therapy. This phenomenon, which is secondary to vascular injury outside the treated segment, was strongly correlated with the development of restenosis at the edges of the treated coronary segment. The European and Canadian SIRIUS trials (E and C-SIRIUS) randomized 350 patients with similar baseline characteristics of the US SIRIUS study. Operators used shorter post-dilatation balloons and direct stented 27% of the patients, achieving a 4.0% TLR rate and a 5.1% in-lesion binary restenosis. These somewhat superior results support the concept that refinement in deployment techniques may further improve clinical outcomes of drug-eluting stents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients needing an intervention and receiving a CYPHER stent.
Key inclusion criteria (3 listed)
- Diagnosis of de novo stenosis in major coronary artery
- Can be treated with stents
- Candidate for bypass
Key exclusion criteria (7 listed)
- Recent, severe MI
- Prior brachytherapy
- Impaired left ventricle function
- Heart transplant recipient
- Impaired renal function
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 |
|---|---|---|
| CYPHER® Bx Velocity™ stent (sirolimus-eluting) | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2009.
- Results publication: PubMed 18549844Costa MA, Angiolillo DJ, Tannenbaum M, Driesman M, Chu A, Patterson J, Kuehl W, Battaglia J, Dabbons S, Shamoon F, Flieshman B, Niederman A, Bass TA; STLLR Investigators. Impact of stent deployment procedural factors on long-term effectiveness and safety of sirolimus-eluting stents (final results of the multicenter prospective STLLR trial). Am J Cardiol. 2008 Jun 15;101(12):1704-11. doi: 10.1016/j.amjcard.2008.02.053. Epub 2008 Apr 9.
- Results publication: PubMed 19455662Suzuki N, Angiolillo DJ, Tannenbaum MA, Driesman MH, Smith C, Bikkina M, Meckel CR, Morales CE, Xenopoulos NP, Coletta JE, Bezerra HG, Bass TA, Costa MA. Strategies for drug-eluting stent treatment of bifurcation coronary artery disease in the United States: insights from the e-Cypher S.T.L.L.R.trial. Catheter Cardiovasc Interv. 2009 Jun 1;73(7):890-7. doi: 10.1002/ccd.21796.
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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.
Amy Orlick study director
Cordis Corporation, a Johnson & Johnson Co.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Stenosis, run by Cordis US Corp..
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 7 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00403338, which also lists 2 linked publications.
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 7 Oct 2009; AzTrials last refreshed its copy on 7 Nov 2026.