Carotid StenosisDW-MRI OUSNCT03985774
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study
An observational study of Carotid Stenosis and Carotid Artery Diseases, run by Silk Road Medical at 3 sites in 3 countries.
Trial summary
The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis, Carotid Artery Diseases, Carotid Atherosclerosis
- What is being tested?
- Transcarotid revascularization
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 26 Feb 2015to 25 Mar 2021
- How long will I take part?
- 30 Days
- 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 enrolled into this study will be comprised of male and female symptomatic patients requiring carotid revascularization.
Who may be able to join
- Patient is symptomatic and has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 60 days of the procedure.
- Target vessel must meet diameter requirements for stent (refer to selected stent IFU for diameter requirements).
- Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
- Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
Who cannot join
- Patient has chronic atrial fibrillation.
- Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
- Patient has an evolving stroke.
- Patient has a history of spontaneous intracranial hemorrhage within the past 12 months.
- Patient has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure.
- Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
Show all 25Show fewer
- Patient has active bleeding diathesis or coagulopathy or will refuse blood transfusion.
- Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.
- Patient has had a recent GI bleed that would interfere with antiplatelet therapy.
- Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, prasugrel, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine, ASA and clopidogrel or ASA and prasugrel.
- Patient with a history of major stroke (CVA) with major neurological deficit likely to confound study endpoints within 1 month of index procedure.
- Patient has an intracranial tumor.
- Patient is actively participating in another drug or device trial (IND or IDE) that has not completed the required protocol follow-up period.
- Patient has inability to understand and cooperate with study procedures.
- Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery.
- Confirmed and uncorrected cardiac sources of emboli.
- Patient has a prosthetic heart valve
- Ostium of Common Carotid Artery (CCA) requires revascularization.
- Presence of extensive or diffuse atherosclerotic disease involving the proximal common carotid artery that would preclude the safe introduction of the study device.
- The patient has less than 5cm between the clavicle and bifurcation, as assessed by duplex Doppler ultrasound.
- Bilateral carotid stenosis if intervention is planned within 37 days of the index procedure.
- An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) that is not associated with an ulcerated target lesion.
- Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis greater in severity than the lesion to be treated, cerebral aneurysm > 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.
- Patient has had a previous intervention in the ipsilateral proximal CCA.
- Patient is otherwise unsuitable for intervention in the opinion of the investigator
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure.
Read the detailed description
The ENROUTE Transcarotid NPS has received CE Mark and is commercially available in the European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease in the context of this study.
This is a prospective, single-arm, multi-center clinical trial of the ENROUTE Transcarotid NPS in conjunction with all commercially approved carotid artery stents used for revascularization in patients with carotid disease.
The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure.
A patient is considered enrolled after:
- meeting all inclusion and none of the exclusion criteria,
- the transcarotid arterial sheath has entered into the patient's vasculature. Insertion of the venous sheath does not qualify a patient as enrolled.
Patients who are screened but do not meet all study criteria are considered screen failures and may not be enrolled. Patients in whom an arterial sheath is placed but who do not meet all study entry criteria are considered enrolled.
The Investigator is responsible for maintaining any information pertaining to the Ethics Committee review and approval as required by local law.
- Being tested
- Transcarotid revascularization
- Medical subject headings
- Carotid Stenosis, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcarotid revascularizationProcedure or surgery
Also called Transcarotid Revascularization (TCAR), Carotid Artery Stenting
The ENROUTE Transcarotid Neuroprotection System (NPS) has received CE Mark and is commercially available in the European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease The ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring carotid revascularization | Symptomatic patients, male or female, with atherosclerotic extracranial internal carotid stenosis (ICA) with or without involvement of the contiguous common artery (CCA), that require carotid revascularization. Receives: Procedure: Transcarotid revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
New White Lesions
Incidence of new white lesions by DW-MRI post procedure.
Measured: 30 days
Secondary outcomes (5)
Periprocedural SAEs
All stroke
Measured: 30 days
Periprocedural SAEs
All death
Measured: 30 days
post-procedure filter debris
filter debris morphology
Measured: 30 days
DW-MRI Lesions
Location of DW-MRI lesions
Measured: 30 days
DW-MRI Lesions
Volume of DW-MRI lesions
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start26 Feb 2015
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies 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
- 31 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Silk Road Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Complejo Hospitalario Toledo, University Ghent, Technical University of Munich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985774
- Sponsor's protocol ID
- SRM-2014-03
- Acronym
- DW-MRI OUS
- Status last verified
- Apr 2021
- First submitted
- 10 Jun 2019
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study
- ClinicalTrials.gov ID
- NCT03985774
- Acronym / sponsor ID
- DW-MRI OUS / SRM-2014-03
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Silk Road MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Complejo Hospitalario Toledo, University Ghent, Technical University of Munich
- Study start
- 26 Feb 2015 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 14 Jun 2019 (actual)
- 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 goal of this study is to evaluate the incidence of post procedure DW-MRI lesions (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure.
Detailed description
The ENROUTE Transcarotid NPS has received CE Mark and is commercially available in the European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease in the context of this study.
This is a prospective, single-arm, multi-center clinical trial of the ENROUTE Transcarotid NPS in conjunction with all commercially approved carotid artery stents used for revascularization in patients with carotid disease.
The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure.
A patient is considered enrolled after:
- meeting all inclusion and none of the exclusion criteria,
- the transcarotid arterial sheath has entered into the patient's vasculature. Insertion of the venous sheath does not qualify a patient as enrolled.
Patients who are screened but do not meet all study criteria are considered screen failures and may not be enrolled. Patients in whom an arterial sheath is placed but who do not meet all study entry criteria are considered enrolled.
The Investigator is responsible for maintaining any information pertaining to the Ethics Committee review and approval as required by local law.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring carotid revascularization | – | Procedure: Transcarotid revascularizationSymptomatic patients, male or female, with atherosclerotic extracranial internal carotid stenosis (ICA) with or without involvement of the contiguous common artery (CCA), that require carotid revascularization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled into this study will be comprised of male and female symptomatic patients requiring carotid revascularization.
Key inclusion criteria (4 listed)
- Patient is symptomatic and has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 60 days of the procedure.
- Target vessel must meet diameter requirements for stent (refer to selected stent IFU for diameter requirements).
- Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
- Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
Key exclusion criteria (25 listed)
- Patient has chronic atrial fibrillation.
- Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
- Patient has an evolving stroke.
- Patient has a history of spontaneous intracranial hemorrhage within the past 12 months.
- Patient has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure.
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 |
|---|---|---|
| Transcarotid revascularizationAlso: Transcarotid Revascularization (TCAR), Carotid Artery StentingThe ENROUTE Transcarotid Neuroprotection System (NPS) has received CE Mark and is commercially available in the European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease The ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis | Procedure or surgery | Patients requiring carotid revascularization |
Primary outcome
New White Lesions
Time frame: 30 days
Incidence of new white lesions by DW-MRI post procedure.
5 secondary outcomes
Periprocedural SAEs
Time frame: 30 days
Periprocedural SAEs
Time frame: 30 days
post-procedure filter debris
Time frame: 30 days
DW-MRI Lesions
Time frame: 30 days
DW-MRI Lesions
Time frame: 30 days
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 19 Apr 2021.
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Stenosis and Carotid Artery Diseases, run by Silk Road Medical at 3 sites in 3 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 4 inclusion and 25 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 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Germany, Spain. 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?
New White Lesions (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 19 Apr 2021.