Coronary Artery DiseasePhase 4SVELTENCT00235066
The CYPHER™ Stent Study in Patients With Small de Novo Coronary Artery Lesions.
A Phase 4 study testing PCI in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Switzerland.
Trial summary
The main objective of this study is to assess the effectiveness of the CYPHER™ (sirolimus-eluting) stent in reducing in-lesion late lumen loss in de novo native coronary artery lesions in small vessels (2.25 - 2.75 mm) as compared to the small vessel tercile of the uncoated Bx VELOCITYTM Stent patients from the SIRIUS… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2002to Apr 2006
- Phase
- Phase 4
- 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
Who may be able to join
- Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS 1, 2, 3, 4) OR unstable angina pectoris (Braunwald Classification B\&C 1-2) OR patients with documented silent ischemia;
- Single treatment of de novo lesion in a small vessel (2.25 - 2.75 mm) in a major coronary artery in patients with single or multivessel disease. Patients with multiple lesions can be included if the other lesions are successfully treated prior to the treatment of the intended lesion in the small vessel.
- Target vessel diameter >=2.25 and <=2.75mm (by visual estimation);
- Target lesion length >=15 and <=30 mm.
Who cannot join
- Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 24 hours or the CK and CK-MB remains above normal at the time of the treatment;
- Has unstable angina classified as Braunwald A (1, 2, 3) or B \& C 3;
- Unprotected left main coronary disease with >=50% stenosis;
- Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
- Have an ostial target lesion;
- Lesion < 2.25 or > 2.75 mm in diameter;
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- Totally occluded vessel (TIMI 0 level);
- Documented left ventricular ejection fraction £30%;
- Intention to treat the target lesion by direct stenting procedure.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital, Swiss Cardiovascular CenterBern
Bern, 3010
About this study
Official title: A Multicenter, Nonrandomized, Historical Controlled Study In Patients With De Novo Coronary Artery Lesions In Small VessELs Treated With The CYPHER™ STEnt
The main objective of this study is to assess the effectiveness of the CYPHER™ (sirolimus-eluting) stent in reducing in-lesion late lumen loss in de novo native coronary artery lesions in small vessels (2.25 - 2.75 mm) as compared to the small vessel tercile of the uncoated Bx VELOCITYTM Stent patients from the SIRIUS Trial, using a stenting technique that minimizes balloon trauma to the vessel and assures full coverage of the lesion with the stent.
Read the detailed description
This is an international, multicenter (up to 10 sites), nonrandomized, historically controlled study in patients with De Novo coronary artery lesions in small vessels treated with the CYPHER™ (sirolimus-eluting) stent as compared to the small vessel tercile uncoated Bx VELOCITYTM Stent patients from the SIRIUS Trial. A total of up to 100 patients will be enrolled in this study.
Patients with de novo native coronary artery lesions >=15mm and <=30mm in length and >=2.25 mm to <=2.75 mm in diameter by visual estimation will be treated with the CYPHER™ (sirolimus-eluting) stent. Patients will be followed at 30 days, 6, 8, 9 months and at 1, 2 and 3 years post-procedure, with a repeat angiography at 8 months. In all patients Intravascular Ultrasound (IVUS) will be performed before (only in case of crossing success) and after the initial procedure. An IVUS control will also be done at 8 months follow up to assess neo-intimal growth and remodeling.
This is a single lesion treatment study. Patients may have other lesions treated before the treatment of the intended lesion in the small vessel (a non-target lesion may not be located in the target vessel!). Post-procedural treatment of another lesion is only allowed after the 30-day follow-up contact has been completed or in case this is clinically needed.
It is anticipated that the total length of the study will be 39 months: 3 months to complete patient enrollment and 3 years for follow-up.
- Conditions
- Coronary Artery Disease
- Being tested
- PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIDevice
Also called drug-eluting stent
PCI with Cypher Sirolimus-Eluting Stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cypher Sirolimus-Eluting Stent Receives: Device: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-lesion late lumen loss
Measured: 8-moths post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startNov 2002
- Primary completionNov 2003
- Study completionApr 2006
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 Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bernhard Meier, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235066
- Sponsor's protocol ID
- EC02-04
- Acronym
- SVELTE
- Status last verified
- Sep 2008
- First submitted
- 6 Oct 2005
- Last updated
- 16 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meier B, Sousa E, Guagliumi G, Van den Branden F, Grenadier E, Windecker S, te Riele H, Voudris V, Eltchaninoff H, Lindvall B, Snead D, Talen A; SVELTE Study Group. Sirolimus-eluting coronary stents in small vessels. Am Heart J. 2006 May;151(5):1019.e1-7. doi: 10.1016/j.ahj.2006.02.025.
PubMed 16644326
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Nonrandomized, Historical Controlled Study In Patients With De Novo Coronary Artery Lesions In Small VessELs Treated With The CYPHER™ STEnt
- ClinicalTrials.gov ID
- NCT00235066
- Acronym / sponsor ID
- SVELTE / EC02-04
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Nov 2003 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 10 Oct 2005 (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 main objective of this study is to assess the effectiveness of the CYPHER™ (sirolimus-eluting) stent in reducing in-lesion late lumen loss in de novo native coronary artery lesions in small vessels (2.25 - 2.75 mm) as compared to the small vessel tercile of the uncoated Bx VELOCITYTM Stent patients from the SIRIUS Trial, using a stenting technique that minimizes balloon trauma to the vessel and assures full coverage of the lesion with the stent.
Detailed description
This is an international, multicenter (up to 10 sites), nonrandomized, historically controlled study in patients with De Novo coronary artery lesions in small vessels treated with the CYPHER™ (sirolimus-eluting) stent as compared to the small vessel tercile uncoated Bx VELOCITYTM Stent patients from the SIRIUS Trial. A total of up to 100 patients will be enrolled in this study.
Patients with de novo native coronary artery lesions >=15mm and <=30mm in length and >=2.25 mm to <=2.75 mm in diameter by visual estimation will be treated with the CYPHER™ (sirolimus-eluting) stent. Patients will be followed at 30 days, 6, 8, 9 months and at 1, 2 and 3 years post-procedure, with a repeat angiography at 8 months. In all patients Intravascular Ultrasound (IVUS) will be performed before (only in case of crossing success) and after the initial procedure. An IVUS control will also be done at 8 months follow up to assess neo-intimal growth and remodeling.
This is a single lesion treatment study. Patients may have other lesions treated before the treatment of the intended lesion in the small vessel (a non-target lesion may not be located in the target vessel!). Post-procedural treatment of another lesion is only allowed after the 30-day follow-up contact has been completed or in case this is clinically needed.
It is anticipated that the total length of the study will be 39 months: 3 months to complete patient enrollment and 3 years for follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: PCICypher Sirolimus-Eluting Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS 1, 2, 3, 4) OR unstable angina pectoris (Braunwald Classification B\&C 1-2) OR patients with documented silent ischemia;
- Single treatment of de novo lesion in a small vessel (2.25 - 2.75 mm) in a major coronary artery in patients with single or multivessel disease. Patients with multiple lesions can be included if the other lesions are successfully treated prior to the treatment of the intended lesion in the small vessel.
- Target vessel diameter >=2.25 and <=2.75mm (by visual estimation);
- Target lesion length >=15 and <=30 mm.
Key exclusion criteria (9 listed)
- Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 24 hours or the CK and CK-MB remains above normal at the time of the treatment;
- Has unstable angina classified as Braunwald A (1, 2, 3) or B \& C 3;
- Unprotected left main coronary disease with >=50% stenosis;
- Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
- Have an ostial target lesion;
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 |
|---|---|---|
| PCIAlso: drug-eluting stentPCI with Cypher Sirolimus-Eluting Stent | Device | 1 |
Primary outcome
In-lesion late lumen loss
Time frame: 8-moths post-procedure
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 16 Sep 2008.
- Results publication: PubMed 16644326Meier B, Sousa E, Guagliumi G, Van den Branden F, Grenadier E, Windecker S, te Riele H, Voudris V, Eltchaninoff H, Lindvall B, Snead D, Talen A; SVELTE Study Group. Sirolimus-eluting coronary stents in small vessels. Am Heart J. 2006 May;151(5):1019.e1-7. doi: 10.1016/j.ahj.2006.02.025.
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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.
Bernhard Meier, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCI in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Switzerland.
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 4 inclusion and 9 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 16 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
In-lesion late lumen loss (time frame: 8-moths post-procedure). 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 NCT00235066, 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 16 Sep 2008.