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Not yet recruitingNCT07886775OASIS-CUpdated Oct 21, 2026

Optical Coherence Tomography-Assisted Strategy for Interventional Management of Symptomatic Carotid Stenosis (OASIS-C)

An interventional study of OCT guided endovascular treatment in Carotid Stenosis, sponsored by Beijing Tiantan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study summary

Optical Coherence Tomography-Assisted Strategy for Interventional Management of Symptomatic Carotid Stenosis (OASIS-C) is a multicenter, prospective, exploratory trial using optical coherence tomography to guide endovascular treatment of carotid stenosis.

Read the detailed description

Carotid artery stenosis is a major cause of ischemic stroke, and its prevalence has increased by 59.1% over 20 years. Among patients with symptomatic severe carotid stenosis receiving medical therapy, the 2-year ipsilateral stroke rate reaches 26%. Although endovascular therapy is considered comparable to carotid endarterectomy in reducing stroke risk, the CAVATAS study showed that carotid artery stenting and carotid balloon angioplasty were associated with 1-year restenosis rates of 13.1% and 25.3%, respectively, and carried a higher risk of stroke. Plaque characteristics may be important determinants of arterial restenosis and stroke events after endovascular treatment. Optical coherence tomography (OCT), currently the highest-resolution intravascular imaging technique, can help characterize plaques to guide the strategy of endovascular treatment for carotid stenosis, reducing restenosis and stroke event rates, and avoiding unnecessary stent placement. All enrolled patients underwent endovascular treatment according to a prespecified OCT-guided strategy. The purpose of this study is to evaluate the safety, feasibility, and clinical value of OCT-guided endovascular therapy in patients with symptomatic carotid stenosis through a multicenter, prospective, exploratory trial.

02

Conditions studied

  • Carotid Stenosis

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Keywords

  • Carotid Stenosis
  • Angioplasty
03

In context

Carotid Stenosis

349 studies on the registry are indexed under Carotid Stenosis; 82 are open to participants now.

This study's planned enrollment of 100 is close to the median of 104 across 188 interventional studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 481 studies on the registry; 287 are open to participants now.

Browse Beijing Tiantan Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
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

  1. Age 20-80 years old.
  2. Primary or recurrent symptomatic extracranial carotid artery stenosis (a recent TIA[\<180 days] or ischemic stroke [14-180 days] before enrollment attributed to 50-99% stenosis of extracranial carotid artery) receiving treatment with at least one antithrombotic drug and/or standard medical management of vascular risk factors.
  3. Diagnosed by DSA: an extracranial carotid artery stenosis (50-99% according to NASCET method) with lesion length ≤ 10mm, diameter ≥ 1.5mm, and normal distal artery. (Regarding the curvature and angle of the lesion, whether the patient is enrolled per the investigator's determination based on the patient's situation ).
  4. Informed consent signed.

Exclusion criteria

Exclusion Criteria:

  1. Acute ischemic stroke onset within 14 days before enrollment.
  2. Neurological deficits worsen within 24 hours before enrollment.
  3. Baseline modified Rankin Scale ≥ 3.
  4. Thrombolytic therapy within 24 hours before enrollment.
  5. Previous ipsilateral endovascular treatment.
  6. Intracranial hemorrhage within the past 3 months.
  7. Any major surgery, major trauma, revascularization procedure, or acute coronary syndrome within 1 month before enrollment.
  8. Major (non-carotid) surgery/procedures planned within 3 months after enrollment.
  9. Gastrointestinal hemorrhage within 1 month prior to enrollment.
  10. Allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and balloon components.
  11. Platelet count \< 100,000/microliter or history of heparin-induced thrombocytopenia.
  12. Severe dysfunction of liver (ALT > three-fold higher than the upper limit of normal value or AST > three-fold higher than the upper limit of normal value) or kidney (serum creatinine > two-fold higher than the upper limit of normal value).
  13. Non-atherosclerotic carotid stenosis (dissection, fibromuscular dysplasia, or stenosis following radiation therapy).
  14. Intracranial arteries, target artery's supplying artery or contralateral carotid artery with 50-99% stenosis.
  15. Coexistent with Intracranial tumors, aneurysms or arteriovenous malformations.
  16. Tortuous vascular approach that cannot be stabilized to obtain vascular access.
  17. Pregnant and lactating women.
  18. Expected survival expectation is less than \< 6 months.
05

Study design

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

Study arms

  • Experimental
    OCT guided endovascular treatment

    All the participants will undergo endovascular treatment guided by OCT.

    Procedure: OCT guided endovascular treatment

Interventions

  • ProcedureOCT guided endovascular treatment

    OCT guides carotid balloon angioplasty and/or stenting of the target artery.

06

What researchers measure

Primary outcomes

  1. Any stroke or death from enrollment to 30 days after endovascular treatment of the qualifying artery, or ipsilateral ischemic stroke or ischemic driven qualifying artery revascularization during the remaining follow-up period up to 6 months

    This outcome includes ischemic/hemorrhagic stroke or all-cause death from enrollment to 30 days after endovascular treatment of the qualifying artery, or ipsilateral ischemic stroke or ischemic driven qualifying artery revascularization during the remaining follow-up period up to 6 months.

    Time frame: 6 months

Secondary outcomes

  1. Any stroke or death from enrollment to 30 days after endovascular treatment of the qualifying artery

    Ischemic/hemorrhagic stroke or all-cause death from enrollment to 30 days after endovascular treatment of the qualifying artery.

    Time frame: 30 days

  2. Any ipsilateral stroke or death within 3 months after enrollment

    Ipsilateral ischemic/hemorrhagic stroke or all-cause death within 3 months after enrollment.

    Time frame: 3 months

  3. Any contralateral stroke within 3 months after enrollment

    Contralateral ischemic/hemorrhagic stroke within 3 months after enrollment.

    Time frame: 3 months

  4. Neurological improvement assessed by mRS at 3 months

    Modified Rankin Scale (mRS score) ranged from 0 to 6 is used to measure the recovery of neurological function in patients after stroke. Score 0 means completely no symptom. Score 6 means death. Higher values represent a worse outcome.

    Time frame: 3 months

  5. Any ipsilateral stroke or death within 6 months after enrollment

    Ipsilateral ischemic/hemorrhagic stroke or all-cause death within 6 months after enrollment.

    Time frame: 6 months

  6. Any contralateral stroke within 6 months after enrollment

    Contralateral ischemic/hemorrhagic stroke within 6 months after enrollment.

    Time frame: 6 months

  7. Ischemic driven qualifying artery revascularization within 6 months after enrollment

    Ischemic driven qualifying artery revascularization within 6 months after enrollment.

    Time frame: 6 months

  8. Neurological improvement assessed by mRS at 6 months

    Modified Rankin Scale (mRS score) ranged from 0 to 6 is used to measure the recovery of neurological function in patients after stroke. Score 0 means completely no symptom. Score 6 means death. Higher values represent a worse outcome.

    Time frame: 6 months

  9. Restenosis of the qualifying artery within 6 months

    Restenosis is defined as rate of stenosis \>70% or increased by 30% based on following-up neurovascular imaging.

    Time frame: 6 months

  10. Combined vascular events within 6 months after enrollment

    Combined vascular events include stroke, myocardial infarction and vascular death. Myocardial infarction occurs when blood stops flowing properly to a part of the heart, and the heart muscle is injured because it is not receiving enough oxygen; vascular death means the death is due to vessel rupture or clot.

    Time frame: 6 months

  11. Quality of life assessment (EuroQol-5-Dimensions Scale [EQ-5D] questionnaire) at 6 months after enrollment

    Quality of life evaluated by EuroQol-5-Dimensions Scale (EQ-5D) questionnaire at the 6 months follow-up. EQ-5D descriptive system covers five dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three response levels (no problem, some problems, and severe problems). The EQ-5D descriptive system generates 243 health states, each of which was assigned a utility. score ranging from -0.59 to 1.00 (full health).

    Time frame: 6 months

  12. Any ipsilateral stroke or death within 12 months after enrollment

    Ipsilateral ischemic/hemorrhagic stroke or all-cause death within 12 months after enrollment.

    Time frame: 12 months

  13. Any contralateral stroke within 12 months after enrollment

    Contralateral ischemic/hemorrhagic stroke within 12 months after enrollment.

    Time frame: 12 months

  14. Ischemic driven qualifying artery revascularization within 12 months after enrollment

    Ischemic driven qualifying artery revascularization within 12 months after enrollment.

    Time frame: 12 months

  15. Neurological improvement assessed by mRS at 12 months

    Modified Rankin Scale (mRS score) ranged from 0 to 6 is used to measure the recovery of neurological function in patients after stroke. Score 0 means completely no symptom. Score 6 means death. Higher values represent a worse outcome.

    Time frame: 12 months

  16. Restenosis of the qualifying artery within 12 months

    Restenosis is defined as rate of stenosis \>70% or increased by 30% based on following-up neurovascular imaging.

    Time frame: 12 months

  17. Combined vascular events within 12 months after enrollment

    Combined vascular events include stroke, myocardial infarction and vascular death. Myocardial infarction occurs when blood stops flowing properly to a part of the heart, and the heart muscle is injured because it is not receiving enough oxygen; vascular death means the death is due to vessel rupture or clot.

    Time frame: 12 months

  18. Any ipsilateral stroke or death within 24 months after enrollment

    Ipsilateral ischemic/hemorrhagic stroke or all-cause death within 24 months after enrollment.

    Time frame: 24 months

  19. Any contralateral stroke within 24 months after enrollment

    Contralateral ischemic/hemorrhagic stroke within 24 months after enrollment.

    Time frame: 24 months

  20. Ischemic driven qualifying artery revascularization within 24 months after enrollment

    Ischemic driven qualifying artery revascularization within 24 months after enrollment.

    Time frame: 24 months

  21. Neurological improvement assessed by mRS at 24 months

    Modified Rankin Scale (mRS score) ranged from 0 to 6 is used to measure the recovery of neurological function in patients after stroke. Score 0 means completely no symptom. Score 6 means death. Higher values represent a worse outcome.

    Time frame: 24 months

  22. Restenosis of the qualifying artery within 24 months

    Restenosis is defined as rate of stenosis \>70% or increased by 30% based on following-up neurovascular imaging.

    Time frame: 24 months

  23. Combined vascular events within 24 months after enrollment

    Combined vascular events include stroke, myocardial infarction and vascular death. Myocardial infarction occurs when blood stops flowing properly to a part of the heart, and the heart muscle is injured because it is not receiving enough oxygen; vascular death means the death is due to vessel rupture or clot.

    Time frame: 24 months

  24. Any ipsilateral stroke or death within 36 months after enrollment

    Ipsilateral ischemic/hemorrhagic stroke or all-cause death within 36 months after enrollment.

    Time frame: 36 months

  25. Any contralateral stroke within 36 months after enrollment

    Contralateral ischemic/hemorrhagic stroke within 36 months after enrollment.

    Time frame: 36 months

  26. Ischemic driven qualifying artery revascularization within 36 months after enrollment

    Ischemic driven qualifying artery revascularization within 36 months after enrollment.

    Time frame: 36 months

  27. Neurological improvement assessed by mRS at 36 months

    Modified Rankin Scale (mRS score) ranged from 0 to 6 is used to measure the recovery of neurological function in patients after stroke. Score 0 means completely no symptom. Score 6 means death. Higher values represent a worse outcome.

    Time frame: 36 months

  28. Restenosis of the qualifying artery within 36 months

    Restenosis is defined as rate of stenosis \>70% or increased by 30% based on following-up neurovascular imaging.

    Time frame: 36 months

  29. Combined vascular events within 36 months after enrollment

    Combined vascular events include stroke, myocardial infarction and vascular death. Myocardial infarction occurs when blood stops flowing properly to a part of the heart, and the heart muscle is injured because it is not receiving enough oxygen; vascular death means the death is due to vessel rupture or clot.

    Time frame: 36 months

07

Study locations

1 site
  • Beijing Tiantan Hospital
    Beijing, Beijing Municipality 100010, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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 Nov 2026; primary completion for May 2029, 30 months later.

Of 49 non-industry interventional studies with no phase under Carotid Stenosis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 50. This study's planned 30 months is above that.

Counting every sponsor, half of 60 studies reached it within 25 months; a quarter within 17 and three quarters within 50.

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

Registered
Oct 15, 2026
First posted
Oct 21, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
May 31, 2029
CompletionEst.
Dec 31, 2029
Last update
Oct 21, 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
Oct 21, 2026
Show all 1 update
  1. Oct 21, 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 ↗

10

Registry details

Key details

Study ID
NCT07886775
Lead sponsor
Beijing Tiantan Hospital
Responsible party
Yiming Deng (MD, Beijing Tiantan Hospital) — Principal investigator
First posted
Oct 21, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
May 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Oct 21, 2026

Study contacts

Yiming Deng, MD
Contact
dengyiming@bjtth.org
13910172189
Zhongrong Miao, MD
principal investigator · Beijing Tiantan Hospital
Ning Ma, MD
principal investigator · Beijing Tiantan Hospital

Oversight

Data monitoring committee
Yes
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 Oct 2026. You cannot join it, but the record below documents what was studied.

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