Atherosclerotic Heart DiseaseNCT01816854
Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent
An observational study of Atherosclerotic Heart Disease, run by be Medical at 1 site in Belgium.
Trial summary
In this prospective study, a newly developed self-expanding nitinol stent is evaluated for the treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Heart Disease
- What is being tested?
- Stenting
- Type of treatment
- Medical device
- How many people
- 117 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Oct 2012to 29 Mar 2017
- How long will I take part?
- 12 Months
- 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: Patients who suffer from intermittent claudication and critical limb ischemia (TASC A, B and C lesions).
Who may be able to join
- Patient must sign informed consent prior to the index-procedure
- Patient must be older than 18 years
- Patient must be compliant with follow-up dates at 1 month and 12 months
- Patients with intermittent claudication (Rutherford 2-3) and critical limb ischemia (Rutherford 4-5)
- Target lesion is located in the superficial femoral artery (minimal 1 cm from origin of SFA and minimal 1 cm above the edge of the patella)
- Reference vessel diameter ≥4.5 and ≤6.5 mm (visual estimate)
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- Patients with a TASC A, B or C lesion
- Diameter stenosis of target lesion >50% or chronic occlusions
- Inflow arteries are free of hemodynamically significant obstruction (i.e. ≥50%)
- The popliteal artery (outflow) is free of hemodynamically significant obstruction (i.e. ≥50%)
- At least 1 patent below-the-knee vessel (anterior tibial artery, posterior tibial artery or peroneal artery) till the ankle confirmed by baseline angiography
Who cannot join
- Patients with Rutherford 1 and 6
- Patiens with Serum creatinine > 2.0 mg/dL or renal dialysis
- Patient takes esomeprazole or omeprazole
- Patient is pregnant
- Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability
- Target lesion cannot be crossed with a guidewire
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- Target lesion is located in the popliteal artery
- Patients with a nickel-titanium allergy
- Patients with an aneurysm in the superficial femoral artery and popliteal artery
- Patients with a TASC D lesion
- Patients with a life expectancy <1 year
- Patients with scheduled elective non-vascular procedures within 3 months after index-procedure, vascular procedures are allowed within 3 months after index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted
- Patients with previous bypass surgery in the SFA
- Patients with intolerance to antithrombotic medication (acetylic salicylic acid, clopidogrel, ticlopidine, glycoprotein IIb/IIIa inhibitors, direct thrombin inhibitors, etc)
- Patient has not been premedicated with acetylic salicylic acid (at least 80 mg/day) 2 hours before the index-procedure
- Patient has not been premedicated with clopidogrel (600 mg/day) 2 hours before the index-procedure
Trial locations and contacts
1 site in 1 country.
About this study
In this prospective study, a newly developed self-expanding nitinol stent is evaluated for the treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery.
- Conditions
- Atherosclerotic Heart Disease
- Being tested
- Stenting
- Keywords
- Peripheral artery disease, SFA, PPA, Self-expandable nitinol stent, Endovascular, Stenosis, Primary pantency
- Medical subject headings
- Coronary Artery Disease, Peripheral Arterial Disease, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentingDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients with PAD | Not described Receives: Device: Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary restenosis
Binary restenosis is defined as a re-obstruction ≥ 50% of the target lesion (peak systolic velocity ratio > 2.4).
Measured: 12 months
Secondary outcomes (10)
Immediate procedural outcome (procedural, technical and device success)
Procedural success: combination of technical success, device success and absence of procedural complications.
Technical success: successful vascular access and completion of the endovascular procedure and immediate morphological success with less than 30% residual diameter reduction of the treated lesion on completion angiography.
Device success: exact deployment of the device according to the instructions for use as documented with suitable imaging modalities and in case of digital substraction angiography, in at least two different imaging projections.
Measured: peri-procedural
Distribution of Rutherford stages
Measured: 12 months
Primary sustained clinical improvement
Defined as sustained upward shift of at least one category on the Rutherford classification without the need for repeated target lesion revascularization (TLR) in surviving patients.
Measured: 12 months
Secondary sustained clinical improvement at 12 months
Defined as sustained upward shift of at least one category on the Rutherford classification including the need for repeated TLR in surviving patients.
Measured: 12 months
Mortality
post-procedural
Measured: 30-day mortality
Mortality
Measured: 12 months
Repeated target lesion revascularization (TLR) rate
Measured: 12 months
Repeated target extremity revascularization (TER) rate
Measured: 12 months
Amputation rate
Measured: 12 months
Rate of patient clopidogrel resistance
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study start8 Oct 2012
- Primary completion29 Mar 2017
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Heart 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
- 117 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- be Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeroen Hendriks, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816854
- Sponsor's protocol ID
- BM-HERO-07-001
- Status last verified
- Dec 2018
- First submitted
- 20 Mar 2013
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent
- ClinicalTrials.gov ID
- NCT01816854
- Acronym / sponsor ID
- BM-HERO-07-001
- Conditions
- Atherosclerotic Heart Disease
- Keywords
- Peripheral artery disease, SFA, PPA, Self-expandable nitinol stent, Endovascular, Stenosis, Primary pantency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- be MedicalIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2012 (actual)
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 22 Mar 2013 (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.
In this prospective study, a newly developed self-expanding nitinol stent is evaluated for the treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PAD | – | Device: Stenting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who suffer from intermittent claudication and critical limb ischemia (TASC A, B and C lesions).
Key inclusion criteria (11 listed)
- Patient must sign informed consent prior to the index-procedure
- Patient must be older than 18 years
- Patient must be compliant with follow-up dates at 1 month and 12 months
- Patients with intermittent claudication (Rutherford 2-3) and critical limb ischemia (Rutherford 4-5)
- Target lesion is located in the superficial femoral artery (minimal 1 cm from origin of SFA and minimal 1 cm above the edge of the patella)
Key exclusion criteria (16 listed)
- Patients with Rutherford 1 and 6
- Patiens with Serum creatinine > 2.0 mg/dL or renal dialysis
- Patient takes esomeprazole or omeprazole
- Patient is pregnant
- Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability
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 | Device | Patients with PAD |
Primary outcome
Binary restenosis
Time frame: 12 months
Binary restenosis is defined as a re-obstruction ≥ 50% of the target lesion (peak systolic velocity ratio > 2.4).
10 secondary outcomes
Immediate procedural outcome (procedural, technical and device success)
Time frame: peri-procedural
Distribution of Rutherford stages
Time frame: 12 months
Primary sustained clinical improvement
Time frame: 12 months
Secondary sustained clinical improvement at 12 months
Time frame: 12 months
Mortality
Time frame: 30-day mortality
Mortality
Time frame: 12 months
Repeated target lesion revascularization (TLR) rate
Time frame: 12 months
Repeated target extremity revascularization (TER) rate
Time frame: 12 months
Amputation rate
Time frame: 12 months
Rate of patient clopidogrel resistance
Time frame: 1 month
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 20 Dec 2018.
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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.
Jeroen Hendriks, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Heart Disease, run by be Medical 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 11 inclusion and 16 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 20 Dec 2018. 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?
Binary restenosis (time frame: 12 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 20 Dec 2018.