Peripheral Artery DiseasePhase 2SIROCCONCT00232869
A Study of the SMART Stent in the Treatment SFA Disease.
A Phase 2 study testing drug-eluting stent and bare-metal stent in people with Peripheral Artery Disease, run by Cordis US Corp. at 1 site in Germany.
Trial summary
The main objective of this study is to assess the safety and performance of the sirolimus coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the treatment of obstructive superficial femoral artery (SFA) disease in reducing percent in-stent mean lumen diameter stenosis in de novo or… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- drug-eluting stent and bare-metal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2001to May 2009
- Phase
- Phase 2
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One superficial femoral artery presenting > 70% stenosis(es) or total occlusion
- Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3 or 4)
Who cannot join
- Tissue loss due to ischemic disease (Rutherford category 5 or 6).
- Tandem lesion requiring non overlapping stents;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Investigation of the SIROlimus Coated Cordis SMART™ Nitinol Selfexpandable Stent for the Treatment of Obstructive Superficial Femoral Artery Disease.
The main objective of this study is to assess the safety and performance of the sirolimus coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the treatment of obstructive superficial femoral artery (SFA) disease in reducing percent in-stent mean lumen diameter stenosis in de novo or restenotic native lesions as compared to the uncoated SMART™ stent.
Read the detailed description
This is a multi-center, prospective, randomized, double blind, two-arm feasibility study evaluating the safety and performance of the sirolimus coated Cordis SMART™ nitinol self-expanding stent and delivery system as compared to the uncoated SMART™ stent and delivery system. It is anticipated that a total of 90 patients will be entered into the study. Patients will be randomized on a 1:1 basis of coated to uncoated stents.
Ninety (90) patients with de novo or restenotic native SFA lesions will be randomized to the Sirolimus Coated SMART™ nitinol self-expanding stent or to the uncoated (bare) SMART™ stent.
Patients will be followed for 24 months post-procedure, with all patients having duplex ultrasound and clinical assessments at discharge, 1, 6, 9, 18 and 24 months, angiography at 6 six months and plain X-ray at 18 months. This study will be conducted at nine investigational sites. (Protocol was amended where 56 additional patients were recruited and followed for up to 5 years.)
- Conditions
- Peripheral Artery Disease
- Being tested
- drug-eluting stent, bare-metal stent
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug-eluting stentDevice
Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent
bare-metal stentDevice
SMART™ bare-metal stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent Receives: Device: drug-eluting stent |
| 2 | Active comparator | SMART™ bare-metal stent Receives: Device: bare-metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent mean lumen diameter percent stenosis via quantitative angiography.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startFeb 2001
- Primary completionJun 2003
- Study completionMay 2009
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 Peripheral 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stephan H Duda, MD, Principal investigator, Tübingen - Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232869
- Sponsor's protocol ID
- EE00-02
- Acronym
- SIROCCO
- Status last verified
- Feb 2010
- First submitted
- 4 Oct 2005
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H, Beregi JP. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006 Dec;13(6):701-10. doi: 10.1583/05-1704.1.
PubMed 17154704
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation of the SIROlimus Coated Cordis SMART™ Nitinol Selfexpandable Stent for the Treatment of Obstructive Superficial Femoral Artery Disease.
- ClinicalTrials.gov ID
- NCT00232869
- Acronym / sponsor ID
- SIROCCO / EE00-02
- Conditions
- Peripheral Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Jun 2003 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 5 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 safety and performance of the sirolimus coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the treatment of obstructive superficial femoral artery (SFA) disease in reducing percent in-stent mean lumen diameter stenosis in de novo or restenotic native lesions as compared to the uncoated SMART™ stent.
Detailed description
This is a multi-center, prospective, randomized, double blind, two-arm feasibility study evaluating the safety and performance of the sirolimus coated Cordis SMART™ nitinol self-expanding stent and delivery system as compared to the uncoated SMART™ stent and delivery system. It is anticipated that a total of 90 patients will be entered into the study. Patients will be randomized on a 1:1 basis of coated to uncoated stents.
Ninety (90) patients with de novo or restenotic native SFA lesions will be randomized to the Sirolimus Coated SMART™ nitinol self-expanding stent or to the uncoated (bare) SMART™ stent.
Patients will be followed for 24 months post-procedure, with all patients having duplex ultrasound and clinical assessments at discharge, 1, 6, 9, 18 and 24 months, angiography at 6 six months and plain X-ray at 18 months. This study will be conducted at nine investigational sites. (Protocol was amended where 56 additional patients were recruited and followed for up to 5 years.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: drug-eluting stentSirolimus Coated Cordis SMART™ nitinol selfexpandable stent |
| 2 | Active comparator | Device: bare-metal stentSMART™ bare-metal stent |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- One superficial femoral artery presenting > 70% stenosis(es) or total occlusion
- Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3 or 4)
Key exclusion criteria (2 listed)
- Tissue loss due to ischemic disease (Rutherford category 5 or 6).
- Tandem lesion requiring non overlapping stents;
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 |
|---|---|---|
| drug-eluting stentSirolimus Coated Cordis SMART™ nitinol selfexpandable stent | Device | 1 |
| bare-metal stentSMART™ bare-metal stent | Device | 2 |
Primary outcome
In-stent mean lumen diameter percent stenosis via quantitative angiography.
Time frame: 6 months.
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 4 Feb 2010.
- Results publication: PubMed 17154704Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H, Beregi JP. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006 Dec;13(6):701-10. doi: 10.1583/05-1704.1.
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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.
Stephan H Duda, MD principal investigator
Tübingen - Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing drug-eluting stent and bare-metal stent in people with Peripheral Artery Disease, run by Cordis US Corp. at 1 site in Germany.
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 2 inclusion and 2 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 4 Feb 2010. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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-stent mean lumen diameter percent stenosis via quantitative angiography. (time frame: 6 months.). 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 NCT00232869, 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 4 Feb 2010.