Superficial Femoral Artery LesionsSTANCENCT01403077
480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo Superficial Femoral Artery (SFA) Lesions
A study testing 480 Biomedical Bioresorbable Scaffold System in people with Superficial Femoral Artery Lesions and Atherosclerosis of Femoral Artery, run by 480 Biomedical at 6 sites in 4 countries.
Trial summary
This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the treatment of subjects with de novo native superficial femoral artery lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Femoral Artery Lesions, Atherosclerosis of Femoral Artery
- What is being tested?
- 480 Biomedical Bioresorbable Scaffold System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Oct 2011to Oct 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 18 years
- De novo stenotic lesion(s) in the superficial femoral artery located at least 1cm distal to the femoral bifurcation and > 3 cm above the knee joint
- Lifestyle-limiting claudication defined as symptomatic subjects with Rutherford Becker Category 2-3
- Target lesion native reference vessel diameter 4.6 - 6.0 mm by on-line QVA; target lesion native reference vessel diameter less than 5.0 mm only if lesion residual stenosis is ≤ 25%
- Lesion length: up to a maximum that can be covered by one 100mm scaffold
- Target lesion > 50% stenosis or total occlusion
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- Undisturbed flow to the foot via at least 2 patent infrapopliteal vessel on the treated side with one vessel free from > 50% stenosis to the ankle joint
- Patent common and external iliac; TASC A \& B lesions may be successfully treated (<30% residual stenosis) at the time of the index procedure
- The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Human Research Ethics Committee (HREC) of the respective clinical site
- The study patient agrees to comply with all required post-procedure follow-up visits
Who cannot join
- Previously implanted stent(s) or stent graft(s) in the target lesion
- Previous endovascular treatment of the target lesion
- Femoral access in the target limb within 30 days of study procedure
- Target lesion residual stenosis > 30% after pre-dilatation with nominally sized balloon
- Severely calcified lesions as determined by a balloon deformity during dilatation with a nominally sized balloon inflated at nominal pressure.
- Acute embolic complication at the trifurcation following pre-dilatation not resolved by aspiration
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- Target vessel contains acute thrombus
- Aneurysm in target vessel
- Critical limb ischemia defined as Rutherford-Becker Category 4-6
- Intolerance, or allergies which cannot be adequately pre-medicated, to the following: aspirin, clopidogrel or ticlopidine, heparin, any scaffold components, contrast agents
- Life expectancy of less than 12 months
- Pregnancy or breast feeding (negative pregnancy test within 7 days required in females of child bearing potential)
- Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease)
- Renal insufficiency (serum creatinine level > 220 µmol/L, or subject is on dialysis)
- Immunocompromised
- Active systemic infection or lower limb infection of any nature
- WBC < 3,000 cells/mm3
- Myocardial infarction within the past 1 month
- Stroke within 3 months
- Un-controlled Atrial-Fibrillation
- Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany3 sites
Universitaet Freiburg-Bad Krozingen
Freiburg im Breisgau
Park Hospital - Heart Center Leipzig
Leipzig
RoMed Klinikum Rosenheim
Rosenheim
About this study
Official title: A Safety Assessment of the 480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo SFA Lesions
This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the treatment of subjects with de novo native superficial femoral artery lesions.
- Being tested
- 480 Biomedical Bioresorbable Scaffold System
- Keywords
- Superficial femoral artery, Peripheral arterial disease, Atherosclerosis, Intermittent Claudication, Vascular Diseases, Cardiovascular Diseases
- Medical subject headings
- Peripheral Arterial Disease, Atherosclerosis, Intermittent Claudication, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
480 Biomedical Bioresorbable Scaffold SystemDevice
480 Biomedical Bioresorbable Scaffold System
| Study group | Role | What they receive |
|---|---|---|
| Scaffold Treatment | Experimental | Not described Receives: Device: 480 Biomedical Bioresorbable Scaffold System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse events at 6 months post procedure
Measured: 6 Months
Secondary outcomes (7)
Major adverse events at 1 month post procedure
Measured: 1 Month
Major adverse events at 3, 12 months and 24 months post procedure
Measured: 3, 12 & 24 Months
Patency in the treated vessel at 1, 3, 6, 12 and 24 months post procedure
Measured: 1, 3, 6, 12, 24 Months
Change in Rutherford Becker Category at 1, 3, 6,12 and 24 months post procedure
Measured: 1, 3, 6, 12, 24 Months
Walking Impairment Questionnaire
Measured: 1, 3, 6, 12, 24 Months
Ankle-Brachial Index (ABI) at 1, 3, 6, 12, and 24 months post procedure
Measured: 1, 3, 6, 12, 24 Months
Clinically driven TLR at 3, 12 and 24 months post procedure
Measured: 3,12, 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Femoral Artery LesionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- 480 Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403077
- Sponsor's protocol ID
- AVI-SFA2011-01
- Acronym
- STANCE
- Status last verified
- Feb 2016
- First submitted
- 25 Jul 2011
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Assessment of the 480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo SFA Lesions
- ClinicalTrials.gov ID
- NCT01403077
- Acronym / sponsor ID
- STANCE / AVI-SFA2011-01
- Keywords
- Superficial femoral artery, Peripheral arterial disease, Atherosclerosis, Intermittent Claudication, Vascular Diseases, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- 480 BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 27 Jul 2011 (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 an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the treatment of subjects with de novo native superficial femoral artery lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scaffold Treatment | Experimental | Device: 480 Biomedical Bioresorbable Scaffold System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >/= 18 years
- De novo stenotic lesion(s) in the superficial femoral artery located at least 1cm distal to the femoral bifurcation and > 3 cm above the knee joint
- Lifestyle-limiting claudication defined as symptomatic subjects with Rutherford Becker Category 2-3
- Target lesion native reference vessel diameter 4.6 - 6.0 mm by on-line QVA; target lesion native reference vessel diameter less than 5.0 mm only if lesion residual stenosis is ≤ 25%
- Lesion length: up to a maximum that can be covered by one 100mm scaffold
Key exclusion criteria (21 listed)
- Previously implanted stent(s) or stent graft(s) in the target lesion
- Previous endovascular treatment of the target lesion
- Femoral access in the target limb within 30 days of study procedure
- Target lesion residual stenosis > 30% after pre-dilatation with nominally sized balloon
- Severely calcified lesions as determined by a balloon deformity during dilatation with a nominally sized balloon inflated at nominal pressure.
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 |
|---|---|---|
| 480 Biomedical Bioresorbable Scaffold System480 Biomedical Bioresorbable Scaffold System | Device | Scaffold Treatment |
Primary outcome
Major adverse events at 6 months post procedure
Time frame: 6 Months
7 secondary outcomes
Major adverse events at 1 month post procedure
Time frame: 1 Month
Major adverse events at 3, 12 months and 24 months post procedure
Time frame: 3, 12 & 24 Months
Patency in the treated vessel at 1, 3, 6, 12 and 24 months post procedure
Time frame: 1, 3, 6, 12, 24 Months
Change in Rutherford Becker Category at 1, 3, 6,12 and 24 months post procedure
Time frame: 1, 3, 6, 12, 24 Months
Walking Impairment Questionnaire
Time frame: 1, 3, 6, 12, 24 Months
Ankle-Brachial Index (ABI) at 1, 3, 6, 12, and 24 months post procedure
Time frame: 1, 3, 6, 12, 24 Months
Clinically driven TLR at 3, 12 and 24 months post procedure
Time frame: 3,12, 24 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 6 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 480 Biomedical Bioresorbable Scaffold System in people with Superficial Femoral Artery Lesions and Atherosclerosis of Femoral Artery, run by 480 Biomedical at 6 sites in 4 countries.
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 10 inclusion and 21 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Australia, Austria, New Zealand. 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?
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?
Major adverse events at 6 months post procedure (time frame: 6 Months). 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 6 Sep 2019.