Superficial Femoral Artery OcclusionsPhase 4SIT-UPNCT00309595
The Study to Compare SMART Nitinol Stent and Balloon Angioplasty
A Phase 4 study testing stent and balloon in people with Superficial Femoral Artery Occlusions, run by Cordis US Corp. at 2 sites in Switzerland.
Trial summary
This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ Nitinol Stent System compared to balloon angioplasty. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Superficial Femoral Artery Occlusions
- What is being tested?
- stent and balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Dec 2005to May 2009
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 3 months;
- One de-novo or restenotic SFA with an occluded length > 5 to < 22 cm;
- Patent popliteal artery on the index side (without > 50% stenotic (re) stenotic lesions) and at least single vessel infrapopliteal runoff (without > 50% stenotic (re) stenotic lesions). However, balloon angioplasty to further improve the blood flow is allowed at the index procedure.
Who cannot join
- Revascularization involving the same limb 30 days prior to the index procedure or a planned revascularization within 30 days after the index procedure;
- Patients having severe stenoses or total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow during the index procedure (prior to the treatment of the target lesion) is allowed;
- Requiring stent placement in the popliteal artery. For the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Univeristy Hospital Bern
Bern, CH-3010
University Hospital Zurich
Zurich, CH-8091
About this study
Official title: A Multi-Center Prospective, Randomized, Two-Arm Clinical Investigation of the Cordis SMARTTM Nitinol Self Expandable Stent Versus Balloon Angioplasty Only for the Treatment of Superficial Femoral Artery Occlusions.
This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ Nitinol Stent System compared to balloon angioplasty. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.
Objective of the study is: Performance of the Cordis S.M.A.R.T.™ (CONTROL™) Nitinol Stent System for the treatment of superficial femoral artery (SFA) long de novo or restenotic lesions (≥ 70% stenosis or occlusions) in comparison with balloon angioplasty as determined by Binary Restenosis (≥50% restenosis based on a peak systolic velocity ratio ≥ 2.5) at one year as demonstrated by Duplex sonography.
Read the detailed description
The study population will consist of 120 symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, de novo or restenotic occlusions (5 - 22 cm) on diagnostic imaging. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. At least one calf vessel must be patent. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.
Trial participants who meet all entry criteria, will be randomized to the SMART™ Nitinol Stent or balloon angioplasty.
Patients will be followed for 12 months after the procedure. Study examinations will be done at screening, procedure time, discharge, 1, 6 and 12 months after the study procedure.
This study will be conducted as an investigator initiated multicenter study with 6 study centers in Switzerland. Principal investigators will be Prof. Amann, PD Dr. med T. Pfammatter (University Hospital Zürich) and Prof. I. Baumgartner, Prof. J. Triller (University Hospital Bern).
- Conditions
- Superficial Femoral Artery Occlusions
- Being tested
- stent, balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stentDevice
Cordis SMART™ Nitinol Stent System
balloonDevice
balloon angioplasty
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cordis SMART™ nitinol self expandable stent Receives: Device: stent |
| 2 | Active comparator | balloon Receives: Device: balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary restenosis by Duplex Ultrasound.
Measured: 1 year
Secondary outcomes (14)
Technical success defined as a successful access and deployment of the device with recanalization.
Measured: at the time of deployment
Procedural complications.
Measured: up to the moment the catheter sheath introducer has been removed
Procedural success as defined by successful recanalization, without the occurence of a Serious Adverse Event (SAE).
Measured: up to the catheter sheath introducer has been removed
Occurrence of Adverse events (AE) and Serious Adverse Events (SAE) in-hospital.
Measured: 1, 6 and 12 months
Ankle Brachial Index (ABI).
Measured: discharge, 1, 6 and 12 months
Restenosis measured by Duplex sonography.
Measured: 1, 6 and 12 months
Target Lesion revascularisation (TLR).
Measured: 1 year
Target Vessel revascularisation (TVR).
Measured: 1 year
Target Limb revascularisation.
Measured: 1 year
The number of revascularisations in both limbs.
Measured: 1 year
Clinical categorization of chronic limb ischemia by means of the Rutherford classification.
Measured: 1, 6 and 12 months
Pain free and absolute walking distance (treadmill testing) as compared to baseline testing.
Measured: 1 and 12 months post index procedure
Amputation of the index limb.
Measured: 1 year
Cardiovascular events (ACS, TIA, stroke, vascular death).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startDec 2005
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Femoral Artery OcclusionsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Iris Baumgartner, MD, Principal investigator, Leitende Aerztin & Leiterin Vaskuläre Forschung - University Hospital BernBeatrice Amann, MD, Principal investigator, Leitende Ärztin Angiologie - University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309595
- Sponsor's protocol ID
- EE04-03
- Acronym
- SIT-UP
- Status last verified
- Jun 2009
- First submitted
- 31 Mar 2006
- Last updated
- 12 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Prospective, Randomized, Two-Arm Clinical Investigation of the Cordis SMARTTM Nitinol Self Expandable Stent Versus Balloon Angioplasty Only for the Treatment of Superficial Femoral Artery Occlusions.
- ClinicalTrials.gov ID
- NCT00309595
- Acronym / sponsor ID
- SIT-UP / EE04-03
- Conditions
- Superficial Femoral Artery Occlusions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 3 Apr 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.
This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ Nitinol Stent System compared to balloon angioplasty. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.
Objective of the study is: Performance of the Cordis S.M.A.R.T.™ (CONTROL™) Nitinol Stent System for the treatment of superficial femoral artery (SFA) long de novo or restenotic lesions (≥ 70% stenosis or occlusions) in comparison with balloon angioplasty as determined by Binary Restenosis (≥50% restenosis based on a peak systolic velocity ratio ≥ 2.5) at one year as demonstrated by Duplex sonography.
Detailed description
The study population will consist of 120 symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, de novo or restenotic occlusions (5 - 22 cm) on diagnostic imaging. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. At least one calf vessel must be patent. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.
Trial participants who meet all entry criteria, will be randomized to the SMART™ Nitinol Stent or balloon angioplasty.
Patients will be followed for 12 months after the procedure. Study examinations will be done at screening, procedure time, discharge, 1, 6 and 12 months after the study procedure.
This study will be conducted as an investigator initiated multicenter study with 6 study centers in Switzerland. Principal investigators will be Prof. Amann, PD Dr. med T. Pfammatter (University Hospital Zürich) and Prof. I. Baumgartner, Prof. J. Triller (University Hospital Bern).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: stentCordis SMART™ nitinol self expandable stent |
| 2 | Active comparator | Device: balloonballoon |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 3 months;
- One de-novo or restenotic SFA with an occluded length > 5 to < 22 cm;
- Patent popliteal artery on the index side (without > 50% stenotic (re) stenotic lesions) and at least single vessel infrapopliteal runoff (without > 50% stenotic (re) stenotic lesions). However, balloon angioplasty to further improve the blood flow is allowed at the index procedure.
Key exclusion criteria (3 listed)
- Revascularization involving the same limb 30 days prior to the index procedure or a planned revascularization within 30 days after the index procedure;
- Patients having severe stenoses or total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow during the index procedure (prior to the treatment of the target lesion) is allowed;
- Requiring stent placement in the popliteal artery. For the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella.
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 |
|---|---|---|
| stentCordis SMART™ Nitinol Stent System | Device | 1 |
| balloonballoon angioplasty | Device | 2 |
Primary outcome
Binary restenosis by Duplex Ultrasound.
Time frame: 1 year
14 secondary outcomes
Technical success defined as a successful access and deployment of the device with recanalization.
Time frame: at the time of deployment
Procedural complications.
Time frame: up to the moment the catheter sheath introducer has been removed
Procedural success as defined by successful recanalization, without the occurence of a Serious Adverse Event (SAE).
Time frame: up to the catheter sheath introducer has been removed
Occurrence of Adverse events (AE) and Serious Adverse Events (SAE) in-hospital.
Time frame: 1, 6 and 12 months
Ankle Brachial Index (ABI).
Time frame: discharge, 1, 6 and 12 months
Restenosis measured by Duplex sonography.
Time frame: 1, 6 and 12 months
Target Lesion revascularisation (TLR).
Time frame: 1 year
Target Vessel revascularisation (TVR).
Time frame: 1 year
Target Limb revascularisation.
Time frame: 1 year
The number of revascularisations in both limbs.
Time frame: 1 year
Clinical categorization of chronic limb ischemia by means of the Rutherford classification.
Time frame: 1, 6 and 12 months
Pain free and absolute walking distance (treadmill testing) as compared to baseline testing.
Time frame: 1 and 12 months post index procedure
Amputation of the index limb.
Time frame: 1 year
Cardiovascular events (ACS, TIA, stroke, vascular death).
Time frame: 1 year
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 12 Jun 2009.
Related trials for Superficial Femoral Artery Occlusions
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Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Embolic Protection for Superficial Femoral Artery Occlusions
Peripheral Artery Disease, Atherectomy in Diseased Lower Extremity Arteries
Not yet recruitingPhase 2/3
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Popliteal Artery Disease, Superficial Femoral Artery Disease
Recruiting
Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
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Active, not recruiting
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
Lower Limb Ischemia, Peripheral Arterial Disease
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.
Iris Baumgartner, MD principal investigator
Leitende Aerztin & Leiterin Vaskuläre Forschung - University Hospital Bern
Beatrice Amann, MD principal investigator
Leitende Ärztin Angiologie - University Hospital Zurich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing stent and balloon in people with Superficial Femoral Artery Occlusions, run by Cordis US Corp. at 2 sites 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 3 inclusion and 3 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 12 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Binary restenosis by Duplex Ultrasound. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2009.