ClinicalTrials.gg
Not yet recruitingNCT07934563Updated Nov 13, 2026

Single-Arm Trial of Carotid Stenting for Carotid Stenosis (Timing Trial)

An interventional study of Carotid Artery Stenting in Carotid Artery Stenosis, Carotid Artery Stenosis Asymptomatic and Atherosclerosis, sponsored by Suzhou Zenith Vascular SciTech Limited. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Suzhou Zenith Vascular SciTech Limited · Not applicable, Interventional, and Treatment

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
208
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 71 studies in Carotid Stenosis with a site in China — 33 open to participants now, 37 under way, 1 of them phase 3. Carotid Stenosis · China.

Planned enrollment
15th of 37
208 · median 178
Started
2026
with 7 others
No phase
26 of 71
13 open now
Primary completion
2028-12
later than 30 of 36 live
Registered
71st of 71
by date

Among the 71 studies in Carotid Stenosis with a site in China, this one is the 15th largest by planned enrollment of the 37 interventional ones that give a count, is one of 8 that started in 2026, is one of 26 with no phase, reaches primary completion later than 30 of the 36 other live ones, and was the 71st registered.

Carotid Stenosis

364 studies on the registry are indexed under Carotid Stenosis; 85 are open to participants now.

Browse Carotid Stenosis studies →

Open to participants now

33 of the 71 studies in Carotid Stenosis with a site in China are open now. Recruiting first, the newest first:

28 more — sign in →

All 33 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 60 Carotid Stenosis studies recruiting now, 38 (63%) set no upper age limit and none (0%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 71 studies in Carotid Stenosis with a site in China, or all of them as a file.
02

Study summary

This is a prospective, multicenter, single-group, target value clinical trial planning to enroll 208 eligible subjects. Participants will be treated with the investigational carotid artery stent system and followed up at discharge, 30 days, 6 months, and 12 months postoperatively to evaluate the safety and efficacy of the device for endovascular treatment of carotid artery stenosis.

03

Conditions studied

  • Carotid Artery Stenosis
  • Carotid Artery Stenosis Asymptomatic
  • Atherosclerosis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

General Inclusion Criteria (all must be satisfied):

  1. Age ≥18 years, either sex.
  2. Preoperative carotid duplex ultrasound (DUS) confirms stenosis of the common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation, and the subject is deemed suitable for endovascular intervention.
  3. Intraoperative digital subtraction angiography (DSA) confirms symptomatic carotid artery stenosis ≥50% or asymptomatic carotid artery stenosis ≥80% (measured by NASCET criteria). Symptomatic is defined as a non-disabling ischemic stroke or (TIA), including cerebral hemisphere events or amaurosis fugax, occurring within 6 months prior to the procedure.
  4. Reference vessel diameter at the target lesion ranges from 3.5 mm to 9.5 mm.
  5. Voluntarily participates in this trial and signs the form.

CEA High-Risk Inclusion Criteria (at least one criterion must be met):

Clinical High-Risk Factors:

  1. Age >80 years.
  2. Low cardiac output [ (LVEF) \<30%].
  3. Untreated or poorly controlled arrhythmia (recurrent despite standard medical therapy or other treatment).
  4. Cardiac insufficiency ( Class III-IV).
  5. Recent myocardial infarction (occurring between 72 hours and 30 days prior to the procedure).
  6. Unstable angina (Canadian Cardiovascular Society Class 3-4).
  7. Severe (COPD), defined as (FEV1) \<50% of predicted value.

Anatomic High-Risk Factors:

  1. Restenosis after prior carotid endarterectomy (CEA).
  2. Contralateral carotid artery occlusion.
  3. Tandem carotid artery lesions.
  4. Carotid artery dissection.
  5. Pseudoaneurysm.

Exclusion criteria

Exclusion Criteria:

  1. Target lesion caused by carotid arteritis.
  2. Target lesion located at the ostium of the common carotid artery.
  3. Severe, long-segment calcification or severe tortuosity at the target lesion preventing adequate stent delivery.
  4. Target lesion is a complete occlusion.
  5. Presence of large acute or subacute thrombus, or arteriovenous malformation adjacent to the target lesion.
  6. Requirement for concurrent stenting or stenting in other territories (intracranial or extracranial) within 30 days after the procedure.
  7. Intracranial hemorrhage within 3 months prior to the procedure.
  8. Large-scale ischemic stroke within 30 days prior to the procedure.
  9. Known intracranial aneurysm that cannot be treated in advance.
  10. Known coagulation disorder ( [APTT] >3 times the ) or abnormal bleeding diathesis.
  11. Known to heparin or antiplatelet agents.
  12. Known allergy to device components, contrast agent, or related materials.
  13. Severe hepatic or renal insufficiency ( [ALT] or aspartate aminotransferase [AST] >5 times the upper limit of normal; serum creatinine >3 times the upper limit of normal).
  14. Uncontrolled severe hypertension (persistent systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg).
  15. Preoperative bradycardia (heart rate \<40 beats per minute).
  16. Preoperative modified Rankin Scale (mRS) score ≥3.
  17. Malignant tumor with extensive .
  18. Currently participating in another drug or device clinical trial.
  19. Pregnant or lactating women, or women planning pregnancy within 1 year.
  20. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this trial.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
208 participants (estimated)

Study arms

  • Experimental
    Carotid Artery Stent System

    Device: Carotid Artery Stenting

Interventions

  • DeviceCarotid Artery Stenting

    All participants will undergo carotid artery stenting (CAS).

06

What researchers measure

Primary outcomes

  1. Incidence of In-Stent Restenosis (ISR)

    Restenosis is defined as ≥50% diameter stenosis occurring within the stent or within 5 mm of the proximal or distal stent edge of the target carotid artery, as assessed by carotid duplex ultrasound (DUS).

    Time frame: through study completion, an average of 1 year

  2. Incidence of Major Adverse Events (MAE)

    Major adverse events (MAE) are defined as the composite incidence of: (1) death, stroke (ischemic or hemorrhagic), or myocardial infarction (MI) occurring within 30 days after the procedure; and (2) death or ipsilateral ischemic stroke of the target vessel occurring from 31 to 365 days after the procedure.

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Device Success Rate

    Defined as the percentage of enrolled subjects in whom device success is achieved. Device success is defined as successful implantation (including delivery, deployment, and expansion) of the stent covering the target lesion, with successful retrieval of the delivery system.

    Time frame: Intraoperative

  2. Procedural Success Rate

    Defined as the percentage of enrolled subjects in whom procedural success is achieved. Procedural success is defined as successful implantation of the stent, with post-procedure angiography demonstrating ≤30% residual stenosis at the target lesion, and freedom from major adverse events (MAE; defined as all-cause death, stroke, or myocardial infarction) prior to hospital discharge.

    Time frame: Perioperative

  3. Incidence of In-Stent Restenosis (ISR)

    Defined as the percentage of enrolled subjects who develop ISR at 6 months post-procedure. ISR is defined as restenosis within the stent or within 5 mm proximal or distal to the stent edge of the target carotid artery, as assessed by carotid duplex ultrasound (DUS), with DUS criteria indicating ≥50% diameter stenosis.

    Time frame: 6 months

  4. Incidence of Target Lesion Revascularization (TLR)

    The percentage of enrolled subjects who undergo TLR within 30 days, at 6 months, and at 12 months post-procedure. TLR is defined as any repeat revascularization (including any surgical or percutaneous intervention) of the target lesion after the initial index procedure.

    Time frame: 30 days,6 months,12 months

  5. Incidence of Ipsilateral Ischemic Stroke

    Defined as the percentage of enrolled subjects who experience an ipsilateral ischemic stroke at 6 months and 12 months post-procedure. Ipsilateral ischemic stroke is defined as an ischemic stroke occurring in the cerebral hemisphere supplied by the target vessel (the carotid artery treated during the index procedure).

    Time frame: 6 months,12 months

  6. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: through study completion, an average of 1 year

  7. Incidence of Device Deficiencies

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.

Of 61 interventional studies with no phase under Carotid Stenosis, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 50. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 13, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Dec 1, 2028
CompletionEst.
Dec 1, 2028
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07934563
Lead sponsor
Suzhou Zenith Vascular SciTech Limited
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Nov 13, 2026

Study contacts

Liqun Jiao
Contact
13911224991@139.com
010-83198277

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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