Peripheral Vascular DiseaseNCT00496041
Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classification
A study testing Registry in people with Peripheral Vascular Disease, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This is a Belgian prospective multicentre registry on the performance of the Smart stent in the superficial femoral artery according to the new tasc II-classification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Registry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2007to 31 Dec 2008
- 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
- Stenosis (> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal)
- New TASC (2007) A, B, or C lesions
- Vessel diameter between 4.5 and 6.5 cm
- Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
- At least 1 outflow vessel down to the ankle
- Signed informed consent
- > Age 50, life expectancy > 1 year
- Capable of concluding the necessary follow-up visits
Who cannot join
- Refusal to participate in the study
- Acute ischemia
- Inflow lesions > 50%, not successfully corrected before the procedure
- Combination with other treatment with the exception of treatment to improve the inflow
Trial locations and contacts
1 site in 1 country.
About this study
This is a Belgian prospective multicentre registry on the performance of the Smart stent in the superficial femoral artery according to the new tasc II-classification.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Registry
- Keywords
- Stenosis (> 75%) or occlusion of the superficial femoral artery
- Medical subject headings
- Peripheral Vascular Diseases, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryProcedure or surgery
A Registry will be used.
| Study group | Role | What they receive |
|---|---|---|
| Smart Stent in the Superficial Femoral Artery . | Experimental | Not described Receives: Procedure: Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency as defined by absence of occlusion or >50% restenosis rate at the level the treated lesion as determined by duplex control.
Measured: 1 year
Secondary outcomes (5)
Patency as defined by absence of occlusion, whether or not after additional intervention to maintain this patency (primary and secondary patency rate)
Measured: 1 year
Target lesion revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis at the level of the stented lesion
Measured: 1 year
Target vessel revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis or a new stenosis in the SFA.
Measured: 1 year
Limbs-salvage rate
Measured: 1 year
Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class.
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 posted4 Jul 2007 (estimated)
- Study startJul 2007
- Primary completion31 Dec 2008
- Study completion31 Dec 2008
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.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Vermassen, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496041
- Sponsor's protocol ID
- 2007/208
- Status last verified
- Mar 2023
- First submitted
- 3 Jul 2007
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classification
- ClinicalTrials.gov ID
- NCT00496041
- Acronym / sponsor ID
- 2007/208
- Conditions
- Peripheral Vascular Disease
- Keywords
- Stenosis (> 75%) or occlusion of the superficial femoral artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jul 2007 (actual)
- Primary completion
- 31 Dec 2008 (actual)
- Study completion
- 31 Dec 2008 (actual)
- First posted
- 4 Jul 2007 (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 on the performance of the Smart stent in the superficial femoral artery according to the new tasc II-classification.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smart Stent in the Superficial Femoral Artery . | Experimental | Procedure: Registry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Stenosis (> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal)
- New TASC (2007) A, B, or C lesions
- Vessel diameter between 4.5 and 6.5 cm
- Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
- At least 1 outflow vessel down to the ankle
Key exclusion criteria (4 listed)
- Refusal to participate in the study
- Acute ischemia
- Inflow lesions > 50%, not successfully corrected before the procedure
- Combination with other treatment with the exception of treatment to improve the inflow
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 |
|---|---|---|
| RegistryA Registry will be used. | Procedure or surgery | Smart Stent in the Superficial Femoral Artery . |
Primary outcome
Patency as defined by absence of occlusion or >50% restenosis rate at the level the treated lesion as determined by duplex control.
Time frame: 1 year
5 secondary outcomes
Patency as defined by absence of occlusion, whether or not after additional intervention to maintain this patency (primary and secondary patency rate)
Time frame: 1 year
Target lesion revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis at the level of the stented lesion
Time frame: 1 year
Target vessel revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis or a new stenosis in the SFA.
Time frame: 1 year
Limbs-salvage rate
Time frame: 1 year
Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class.
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 16 Mar 2023.
- Website of the University Hospital GhentLink provided by the sponsor.
Related trials for Peripheral Vascular Disease
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
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.
Frank Vermassen, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Registry in people with Peripheral Vascular Disease, run by University Hospital, Ghent at 1 site 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 8 inclusion and 4 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 16 Mar 2023. 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 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?
Patency as defined by absence of occlusion or >50% restenosis rate at the level the treated lesion as determined by duplex control. (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 16 Mar 2023.