Peripheral Vascular DiseaseNCT01139177
SAMBA EU Femoropopliteal Trial
A study testing Stenting of atherosclerotic lesion(s) in people with Peripheral Vascular Disease, run by NovoStent Corporation at 2 sites in Germany.
Trial summary
The primary objective of this study is to evaluate the safety and performance of the SAMBA Stent and Delivery System in the treatment of femoropopliteal lesions. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Stenting of atherosclerotic lesion(s)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2009to Sep 2010
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screening
- Patient must be ≥ 21 years of age with life expectancy > 1 year.
- Symptomatic leg ischemia requiring treatment of the superficial femoral and/or popliteal artery (Rutherford category 2-4; claudication, rest pain).
- Patient must be a suitable candidate for PTA and stenting.
- Patient is willing and able to return to the site of the investigation at the specified study intervals and undergo follow-up requirements.
- The patient or legal representative has provided written informed consent using a form that is reviewed and approved by the EC for the Clinical Site.
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- Pre-Intervention
- Target lesion has ≥ 50% stenosis as demonstrated angiographically.
- Lesion length ≤ 15 cm.
- Reference vessel diameter of 5 to 6 mm.
- Patient has at least 1 vessel run-off prior to treatment.
Who cannot join
- Screening
- The subject is pregnant or will become pregnant during the study or has any other condition that would preclude having x-rays. (Pre-menopausal women must have a negative pregnancy test within 7 days of the procedure.)
- Patients who have experienced a cardiovascular accident (CVA) or a myocardial infarction (MI) within 3 months prior to the procedure.
- Subject has had or plans to have a surgical or interventional procedure within 30 days before or after the implantation procedure of the SAMBA Stent.
- Existing hemorrhagic disease or coagulation problems or inability to take dual anti-platelet therapy.
- Contrast allergy that cannot be corrected with medication (e.g. steroids, etc.).
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- Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment.
- Patient is currently participating in another investigational drug or device study.
- Pre-Intervention
- Uncorrectable severe aorto-iliac occlusive disease or severe common femoral artery stenosis preventing access or limiting inflow (e.g., stenosis greater than 50%).
- Uncorrectable occlusive disease limiting outflow (e.g., stenosis greater than 50%)
- Patients with previous surgery in the target vessel or stent that will be closer than 2 cm to either edge of SAMBA Stent(s).
- Lack of 1 cm of healthy vessel proximal to proximal target
- Lack of popliteal reconstitution (at least 2 cm of normal distal popliteal).
- Inability to cross the lesion with a guidewire.
- More than 1 lesion in the same limb requiring treatment that will not be covered by continuous stenting.
- Unsuccessful balloon pre-dilation (i.e., the residual stenosis is greater than 30%).
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Herz Zentrum Bad Krozingen
Bad Krozingen, D 79189
Herz-Zentrum Leipzig
Leipzig, D-04289
About this study
The primary objective of this study is to evaluate the safety and performance of the SAMBA Stent and Delivery System in the treatment of femoropopliteal lesions.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Stenting of atherosclerotic lesion(s)
- Keywords
- Peripheral vascular disease - SFA and popliteal arteries.
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stenting of atherosclerotic lesion(s)Device
Also called SAMBA Stent and Delivery System
Stenting of atherosclerotic lesions post pre-dilatation of lesion(s)
| Study group | Role | What they receive |
|---|---|---|
| Stent placement | Experimental | Not described Receives: Device: Stenting of atherosclerotic lesion(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety endpoint is defined as freedom from all cause death, unplanned index limb amputation, and target lesion revascularization.
Measured: through 30 days
The primary efficacy endpoint is defined as stent patency via Color Duplex Ultrasound (Peak Velocity Ratio ≤ 2.5).
Measured: 3 months
Secondary outcomes (4)
Clinically-Driven Target Lesion Revascularization (i.e., with documented preintervention evidence of at least 50% diameter stenosis (quantitative angiographic ≥ 50% or PSVR > 2.5).
Measured: 12 months
Change in Rutherford Classification compared to pre-implant.
Measured: 12 months
Stent Patency via Color Duplex Ultrasound (Peak Systolic Velocity Ratio ≤ 2.5).
Measured: 12 months
Stent Fractures.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startApr 2009
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoStent Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dierk Scheinert, MD, Principal investigator, Herz-Zentrum Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139177
- Sponsor's protocol ID
- 60-00857-01
- Status last verified
- Jun 2010
- First submitted
- 4 Jun 2010
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAMBA EU Femoropopliteal Trial
- ClinicalTrials.gov ID
- NCT01139177
- Acronym / sponsor ID
- 60-00857-01
- Conditions
- Peripheral Vascular Disease
- Keywords
- Peripheral vascular disease - SFA and popliteal arteries.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- NovoStent CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 8 Jun 2010 (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 primary objective of this study is to evaluate the safety and performance of the SAMBA Stent and Delivery System in the treatment of femoropopliteal lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stent placement | Experimental | Device: Stenting of atherosclerotic lesion(s) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Screening
- Patient must be ≥ 21 years of age with life expectancy > 1 year.
- Symptomatic leg ischemia requiring treatment of the superficial femoral and/or popliteal artery (Rutherford category 2-4; claudication, rest pain).
- Patient must be a suitable candidate for PTA and stenting.
- Patient is willing and able to return to the site of the investigation at the specified study intervals and undergo follow-up requirements.
Key exclusion criteria (17 listed)
- Screening
- The subject is pregnant or will become pregnant during the study or has any other condition that would preclude having x-rays. (Pre-menopausal women must have a negative pregnancy test within 7 days of the procedure.)
- Patients who have experienced a cardiovascular accident (CVA) or a myocardial infarction (MI) within 3 months prior to the procedure.
- Subject has had or plans to have a surgical or interventional procedure within 30 days before or after the implantation procedure of the SAMBA Stent.
- Existing hemorrhagic disease or coagulation problems or inability to take dual anti-platelet therapy.
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 |
|---|---|---|
| Stenting of atherosclerotic lesion(s)Also: SAMBA Stent and Delivery SystemStenting of atherosclerotic lesions post pre-dilatation of lesion(s) | Device | Stent placement |
Primary outcome
The primary safety endpoint is defined as freedom from all cause death, unplanned index limb amputation, and target lesion revascularization.
Time frame: through 30 days
The primary efficacy endpoint is defined as stent patency via Color Duplex Ultrasound (Peak Velocity Ratio ≤ 2.5).
Time frame: 3 months
4 secondary outcomes
Clinically-Driven Target Lesion Revascularization (i.e., with documented preintervention evidence of at least 50% diameter stenosis (quantitative angiographic ≥ 50% or PSVR > 2.5).
Time frame: 12 months
Change in Rutherford Classification compared to pre-implant.
Time frame: 12 months
Stent Patency via Color Duplex Ultrasound (Peak Systolic Velocity Ratio ≤ 2.5).
Time frame: 12 months
Stent Fractures.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
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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.
Dierk Scheinert, MD principal investigator
Herz-Zentrum Leipzig
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stenting of atherosclerotic lesion(s) in people with Peripheral Vascular Disease, run by NovoStent Corporation at 2 sites 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 11 inclusion and 17 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 8 Jun 2010. 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 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.
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?
The primary safety endpoint is defined as freedom from all cause death, unplanned index limb amputation, and target lesion revascularization. (time frame: through 30 days). The study lists 2 primary outcomes in all. 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 8 Jun 2010; AzTrials last refreshed its copy on 6 Nov 2026.