Carotid Artery StenosisASCENT-CNCT07458243
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
An observational study of Carotid Artery Stenosis, run by Boston Scientific Corporation.
Trial summary
The study is a prospective, non-randomized, single-arm, multi-center registry to confirm the safe delivery of the Carotid WALLSTENT Endoprosthesis when used with the ENROUTE® Transcarotid Neuroprotection System in the Chinese population Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- transcarotid artery revascularization
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2027to 30 Sep 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Subjects will come from patients in each sites.
Who may be able to join
- 1. Patients must meet one of the following criteria regarding neurological symptom status and degree of stenosis: Symptomatic: Stenosis must be >50% as determined by an angiogram (CTA/MRA or catheter angiogram prior to the index procedure) and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and/or amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be stented.
- OR Asymptomatic: Stenosis must be ≥70% as determined by angiogram (CTA/MRA or catheter angiogram prior to the index procedure) without any neurological symptoms within the prior 180 days.
- 2. Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and Carotid WALLSTENT Endoprosthesis (refer to IFU for requirements).
- 3. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
- 4. Patient is ≥18 years of age. 5. Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Institutional Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.
- 6. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
Who cannot join
- 1. Patient has an alternative source of cerebral embolus, including but not limited to:
- 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.
- Knowledge of any cardiac sources of emboli. (including but not limited to left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).
- Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.
- Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA/MRA ≤ 6 months prior to index procedure) 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.
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- 2. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or 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.
- 3. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
- 4. Patient with a history of major stroke attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS ≥ 3) likely to confound study endpoints within 1 month of index procedure.
- 5. Patient has an intracranial tumor. 6. Patient has an evolving stroke. 7. Patient has neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke, including but not limited to: moderate to severe dementia, partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, or intracranial hemorrhage).
- 8. Patient has had a TIA or amaurosis fugax within 48 hrs prior to the procedure.
- 9. Patient has an isolated hemisphere. 10. Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.
- 11. Myocardial Infarction within 72 hours prior to the intervention. 12. Presence of a previous placed intravascular stent in target vessel or ipsilateral CCA or significant CCA inflow lesion.
- 13. Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery.
- 14. 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) whether or not it is associated with an ulcerated target lesion.
- 15. Ostium of Common Carotid Artery (CCA) requires revascularization. 16. Patient has an open stoma in the neck. 17. Female patients who are pregnant or may become pregnant. 18. 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 (or other P2Y12 inhibitors) , statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine or ASA and clopidogrel or ASA and alternative P2Y12 inhibitor (e.g. ticagrelor [Brilinta], prasugrel [Effient]).
- 19. Patient has a life expectancy <1 year (for symptomatic group regardless of surgical risk designation), or <3 years (for asymptomatic HSR group), or < 5 years (for asymptomatic SSR group) without contingencies related to other medical, surgical, or interventional procedures as per the Wallaert Score (for asymptomatic patients) and patients with primary, recurrent or metastatic malignancy who do not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.
- 20. Patient has an unresolved or uncorrected bleeding disorder, known bleeding diathesis or hypercoagulable state.
About this study
The study is a prospective, non-randomized, single-arm, multi-center registry to confirm the safe delivery of the Carotid WALLSTENT Endoprosthesis when used with the ENROUTE® Transcarotid Neuroprotection System in the Chinese population
- Conditions
- Carotid Artery Stenosis
- Being tested
- transcarotid artery revascularization
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcarotid artery revascularizationDevice
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) 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 and who have appropriate anatomy described below:
- Adequate femoral venous access
- Common carotid artery reference diameter of at least 6 mm
- Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography.
What is being measured
The primary outcome is the main question the study is designed to answer.
• Procedural success
technical success in the absence of a Major Adverse Event
Measured: 30-days of the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start28 Feb 2027 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458243
- Sponsor's protocol ID
- S10093
- Acronym
- ASCENT-C
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
- ClinicalTrials.gov ID
- NCT07458243
- Acronym / sponsor ID
- ASCENT-C / S10093
- Conditions
- Carotid Artery Stenosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2027 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 Mar 2026 (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 study is a prospective, non-randomized, single-arm, multi-center registry to confirm the safe delivery of the Carotid WALLSTENT Endoprosthesis when used with the ENROUTE® Transcarotid Neuroprotection System in the Chinese population
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will come from patients in each sites.
Key inclusion criteria (6 listed)
- 1. Patients must meet one of the following criteria regarding neurological symptom status and degree of stenosis: Symptomatic: Stenosis must be >50% as determined by an angiogram (CTA/MRA or catheter angiogram prior to the index procedure) and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and/or amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be stented.
- OR Asymptomatic: Stenosis must be ≥70% as determined by angiogram (CTA/MRA or catheter angiogram prior to the index procedure) without any neurological symptoms within the prior 180 days.
- 2. Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and Carotid WALLSTENT Endoprosthesis (refer to IFU for requirements).
- 3. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
- 4. Patient is ≥18 years of age. 5. Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Institutional Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.
Key exclusion criteria (18 listed)
- 1. Patient has an alternative source of cerebral embolus, including but not limited to:
- 2. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or 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.
- 3. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
- 4. Patient with a history of major stroke attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS ≥ 3) likely to confound study endpoints within 1 month of index procedure.
- 5. Patient has an intracranial tumor. 6. Patient has an evolving stroke. 7. Patient has neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke, including but not limited to: moderate to severe dementia, partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, or intracranial hemorrhage).
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 artery revascularizationThe ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) 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 and who have appropriate anatomy described below: * Adequate femoral venous access * Common carotid artery reference diameter of at least 6 mm * Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography. | Device | – |
Primary outcome
• Procedural success
Time frame: 30-days of the index procedure
technical success in the absence of a Major Adverse Event
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis, run by Boston Scientific Corporation.
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 6 inclusion and 18 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
• Procedural success (time frame: 30-days of the index procedure). 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 30 Oct 2026.