Peripheral Arterial DiseaseBOSSNCT01499342
Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent in the Superficial Femoral Artery
An observational study of Peripheral Arterial Disease, run by be Medical at 2 sites in Belgium.
Trial summary
This is a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions. Target number is 500 patients in approximately 11 centres. Patients will be followed for a period of 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 435 participants
- Where
- 2 sitesBelgium
- Study dates
- Nov 2009to Feb 2014
- Phase
- Observational
- 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
Study population: Stenosis (> 75%) or occlusion of the superficial femoral artery.
Who may be able to join
- Signed informed consent
- Stenosis (> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal and 4 cm proximal to the patella)
- TASC II (2007)type A, B or C lesions
- Target vessel diameter between 4.5 and 7 mm
- Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
- At least 1 outflow vessel down to the ankle
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- Patient is at least 18 years old
- Life expectancy > 2 years
- Patient is compliant with the requested follow-up visits
Who cannot join
- No informed consent
- Rutherford 6
- TASC II type D lesions
- Patient is not 18 years old
- Patient is pregnant
- Acute ischemia
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- Patient is not compliant with the requested follow-up visits
- Unable to cross target lesion with guidewire
- Patient is allergic to nickel-titanium
- Presence of an aneurysm in the SFA
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ziekenhuis Oost Limburg
Genk, Limburg, 3600
University Hospital Leuven
Leuven, Vlaams Brabant, 3000
About this study
Official title: Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent to Treat Atherosclerotic Lesions in the Superficial Femoral Artery
This is a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions. Target number is 500 patients in approximately 11 centres. Patients will be followed for a period of 2 years.
- Conditions
- Peripheral Arterial Disease
- Keywords
- Stent, Atherosclerotic occlusive disease, Peripheral arterial disease, Superficial femoral artery, SFA
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Rutherford category 2 - 5 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
Primary patency rate at 12 and 24 months as determined by Duplex ultrasound, defined as <50% diameter restenosis(systolic velocity ratio no greater than 2.4) at the level of the treated lesion, without occurrence of target lesion revasularization between the index-procedure and the 12 and 24 months follow-up.
Measured: 12, 24 months
Secondary outcomes (5)
Secondary patency
Patency as defined by absence of >50% restenosis , whether or not after additional intervention to maintain this patency
Measured: 12 and 24 months
Target lesion revascularization
Target lesion revascularisation rate as defined by the number of new revascularizations (endovascular or surgery) carried out due to restenosis or thrombosis at the level of the stented lesion
Measured: 12 and 24 months
Target vessel revascularization
Target vessel revascularization rate as defined by the number of new revascularizations (endovascular or surgery) carried out due to restenosis or a new stenosis in the SFA
Measured: 12 and 24 months
Limb-salvage rate
Measured: 12 and 24 months
Clinical success rate
Clinical success rate defined asimprovement in symptoms according to the Rutherford classification by a minimum of 1 class.
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startNov 2009
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- be Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Ziekenhuis Oost-Limburg
- Responsible party
- Sponsor
- Investigators
- Sabrina Houthoofd, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenHerman Schroë, MD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499342
- Sponsor's protocol ID
- BM/BOSS 02-002
- Acronym
- BOSS
- Status last verified
- May 2014
- First submitted
- 21 Apr 2011
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent to Treat Atherosclerotic Lesions in the Superficial Femoral Artery
- ClinicalTrials.gov ID
- NCT01499342
- Acronym / sponsor ID
- BOSS / BM/BOSS 02-002
- Conditions
- Peripheral Arterial Disease
- Keywords
- Stent, Atherosclerotic occlusive disease, Peripheral arterial disease, Superficial femoral artery, SFA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- be MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Ziekenhuis Oost-Limburg
- Study start
- Nov 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Dec 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 a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions. Target number is 500 patients in approximately 11 centres. Patients will be followed for a period of 2 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rutherford category 2 - 5 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stenosis (> 75%) or occlusion of the superficial femoral artery.
Key inclusion criteria (9 listed)
- Signed informed consent
- Stenosis (> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal and 4 cm proximal to the patella)
- TASC II (2007)type A, B or C lesions
- Target vessel diameter between 4.5 and 7 mm
- Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
Key exclusion criteria (10 listed)
- No informed consent
- Rutherford 6
- TASC II type D lesions
- Patient is not 18 years old
- Patient is pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary patency
Time frame: 12, 24 months
Primary patency rate at 12 and 24 months as determined by Duplex ultrasound, defined as <50% diameter restenosis(systolic velocity ratio no greater than 2.4) at the level of the treated lesion, without occurrence of target lesion revasularization between the index-procedure and the 12 and 24 months follow-up.
5 secondary outcomes
Secondary patency
Time frame: 12 and 24 months
Target lesion revascularization
Time frame: 12 and 24 months
Target vessel revascularization
Time frame: 12 and 24 months
Limb-salvage rate
Time frame: 12 and 24 months
Clinical success rate
Time frame: 12 and 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 22 Aug 2022.
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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.
Sabrina Houthoofd, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
Herman Schroë, MD principal investigator
Ziekenhuis Oost-Limburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by be Medical at 2 sites in Belgium.
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 9 inclusion and 10 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 22 Aug 2022. 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 Belgium. 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?
Primary patency (time frame: 12, 24 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 22 Aug 2022.