Peripheral Arterial DiseasePhase 2/3NCT02529345
Clear-Road Trial, Investigating the Efficacy of the RoadSaver Stent
A Phase 2/3 study testing RoadSaver stent in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 4 sites in Belgium.
Trial summary
The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- RoadSaver stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesBelgium
- Study dates
- Apr 2015to May 2017
- Phase
- Phase 2/3
- 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
- High risk for carotid endarterectomy due to anatomical or co-morbid conditions and either:
- has neurological symptoms and ≥ 50% stenosis via angiography, or
- is asymptomatic and has ≥ 80% stenosis via angiography.
- Target lesion located in the distal common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation.
- Arterial segment to be stented has a diameter between 4mm and 9mm
- Age ≥ 18 years.
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- Life expectancy > 12 months from the date of the index procedure.
- Provides a signed, IRB (Institutional Review Board) / IEC (Institutional Ethical Committee) approved informed consent form prior to participation.
- Willing and able to comply with follow-up requirements.
Who cannot join
- Contra-indication to percutaneous transluminal angioplasty (PTA).
- Sever vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system.
- Lesions in the ostium of the common carotid artery.
- Occlusion of the target vessel.
- Evidence of intraluminal thrombus.
- Known sensitivity to nickel-titanium.
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- Known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies, or is unable or unwilling to tolerate such therapies.
- Uncorrectable bleeding disorders, or will refuse block transfusion.
- History of prior life-threatening contrast media reaction.
- Previous stent placement in the target vessel.
- Evolving stroke or intracranial haemorrhage.
- Previous intracranial haemorrhage or brain surgery within the past 12 months.
- Clinical condition that makes endovascular therapy impossible or hazardous.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
OLV Aalst
Aalst, Oost-Vlaanderen, 9300
Imelda Hospital
Bonheiden, Antwerp, 2820
AZ Sint-Blasius
Dendermonde, Oost-Vlaanderen, 9200
RZ Heilig Hart Hospital
Tienen, 3300
About this study
Official title: CLEAR-ROAD; a Physician-initiated Carotid Trial Investigating the Efficacy of Endovascular Treatment of Carotid Arterial Disease With the Multi-layer RoadSaver Stent
The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.
Read the detailed description
It is a Prospective, multi-center, physician-sponsored clinical study.
The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.
- Conditions
- Peripheral Arterial Disease
- Being tested
- RoadSaver stent
- 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.
RoadSaver stentDevice
lesion treated with RoadSaver stent of Terumo
| Study group | Role | What they receive |
|---|---|---|
| RoadSaver stent | Experimental | patient treated with the RoadSaver stent of Terumo Receives: Device: RoadSaver stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day rate of Major Adverse events (MAE)
The primary endpoint of this study is the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any peri-procedural (≤ 30 days post-procedure) death, stroke or myocardial infarction (MI).
Measured: 30 days
Secondary outcomes (7)
Late Ipsilateral stroke
number of patients presenting late ipsilateral stroke within day 31 through 365 days
Measured: day 31 through 365 days
System Technical Success
Defined as the ability to cross and stent the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging.
Measured: procedure (day 0)
device malfunctions
number of device malfunctions during procedure
Measured: procedure (day 0)
Major Adverse Events (MAE's)
number of MAE's at the different time frames
Measured: at 1,6 and 12 month follow-up
serious device-related and procedure-related Adverse Events (SAE's)
number of SAE's at the different time frames
Measured: at 1, 6 and 12 month follow-up
freedom from Target Lesion Revascularization (TLR)
Defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal an distal to the treated lesion edge.
Measured: at 1, 6 and 12-month follow-up
in-stent restenosis (ISR)
patients representing ISR at the different time frames
Measured: at 1, 6 and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016
- Study completionMay 2017
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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flanders Medical Research Program
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Marc Bosiers, MD, Principal investigator, A.Z. Sint-Blasius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529345
- Sponsor's protocol ID
- FMRP-130919
- Status last verified
- Jul 2017
- First submitted
- 27 Apr 2015
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLEAR-ROAD; a Physician-initiated Carotid Trial Investigating the Efficacy of Endovascular Treatment of Carotid Arterial Disease With the Multi-layer RoadSaver Stent
- ClinicalTrials.gov ID
- NCT02529345
- Acronym / sponsor ID
- FMRP-130919
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Flanders Medical Research ProgramResearch network
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 20 Aug 2015 (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 objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.
Detailed description
It is a Prospective, multi-center, physician-sponsored clinical study.
The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RoadSaver stent | Experimental | Device: RoadSaver stentpatient treated with the RoadSaver stent of Terumo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- High risk for carotid endarterectomy due to anatomical or co-morbid conditions and either:
- has neurological symptoms and ≥ 50% stenosis via angiography, or
- is asymptomatic and has ≥ 80% stenosis via angiography.
Key exclusion criteria (13 listed)
- Contra-indication to percutaneous transluminal angioplasty (PTA).
- Sever vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system.
- Lesions in the ostium of the common carotid artery.
- Occlusion of the target vessel.
- Evidence of intraluminal thrombus.
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 |
|---|---|---|
| RoadSaver stentlesion treated with RoadSaver stent of Terumo | Device | RoadSaver stent |
Primary outcome
30-day rate of Major Adverse events (MAE)
Time frame: 30 days
The primary endpoint of this study is the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any peri-procedural (≤ 30 days post-procedure) death, stroke or myocardial infarction (MI).
7 secondary outcomes
Late Ipsilateral stroke
Time frame: day 31 through 365 days
System Technical Success
Time frame: procedure (day 0)
device malfunctions
Time frame: procedure (day 0)
Major Adverse Events (MAE's)
Time frame: at 1,6 and 12 month follow-up
serious device-related and procedure-related Adverse Events (SAE's)
Time frame: at 1, 6 and 12 month follow-up
freedom from Target Lesion Revascularization (TLR)
Time frame: at 1, 6 and 12-month follow-up
in-stent restenosis (ISR)
Time frame: at 1, 6 and 12 month follow-up
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 1 Aug 2017.
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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.
Marc Bosiers, MD principal investigator
A.Z. Sint-Blasius Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RoadSaver stent in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 4 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 13 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 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
30-day rate of Major Adverse events (MAE) (time frame: 30 days). 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 1 Aug 2017.