Carotid StenosisOASIS-CNCT07886775
Optical Coherence Tomography-Assisted Strategy for Interventional Management of Symptomatic Carotid Stenosis (OASIS-C)
A study testing OCT guided endovascular treatment in people with Carotid Stenosis, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- OCT guided endovascular treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 31 Dec 2029
- Phase
- Interventional
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-80 years old.
- 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.
- 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 ).
- Informed consent signed.
Who cannot join
- Acute ischemic stroke onset within 14 days before enrollment.
- Neurological deficits worsen within 24 hours before enrollment.
- Baseline modified Rankin Scale ≥ 3.
- Thrombolytic therapy within 24 hours before enrollment.
- Previous ipsilateral endovascular treatment.
- Intracranial hemorrhage within the past 3 months.
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- Any major surgery, major trauma, revascularization procedure, or acute coronary syndrome within 1 month before enrollment.
- Major (non-carotid) surgery/procedures planned within 3 months after enrollment.
- Gastrointestinal hemorrhage within 1 month prior to enrollment.
- Allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and balloon components.
- Platelet count < 100,000/microliter or history of heparin-induced thrombocytopenia.
- 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).
- Non-atherosclerotic carotid stenosis (dissection, fibromuscular dysplasia, or stenosis following radiation therapy).
- Intracranial arteries, target artery's supplying artery or contralateral carotid artery with 50-99% stenosis.
- Coexistent with Intracranial tumors, aneurysms or arteriovenous malformations.
- Tortuous vascular approach that cannot be stabilized to obtain vascular access.
- Pregnant and lactating women.
- Expected survival expectation is less than < 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100010
Yiming Deng, MD, 13910172189, dengyiming@bjtth.org
About this study
Official title: A Multicenter, Prospective and Exploratory Study of Optical Coherence Tomography-Assisted Strategy for Interventional Management of Symptomatic Carotid Stenosis
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.
- Conditions
- Carotid Stenosis
- Being tested
- OCT guided endovascular treatment
- Keywords
- Carotid Stenosis, Angioplasty
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT guided endovascular treatmentProcedure or surgery
OCT guides carotid balloon angioplasty and/or stenting of the target artery.
| Study group | Role | What they receive |
|---|---|---|
| OCT guided endovascular treatment | Experimental | All the participants will undergo endovascular treatment guided by OCT. Receives: Procedure: OCT guided endovascular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (29)
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.
Measured: 30 days
Any ipsilateral stroke or death within 3 months after enrollment
Ipsilateral ischemic/hemorrhagic stroke or all-cause death within 3 months after enrollment.
Measured: 3 months
Any contralateral stroke within 3 months after enrollment
Contralateral ischemic/hemorrhagic stroke within 3 months after enrollment.
Measured: 3 months
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.
Measured: 3 months
Any ipsilateral stroke or death within 6 months after enrollment
Ipsilateral ischemic/hemorrhagic stroke or all-cause death within 6 months after enrollment.
Measured: 6 months
Any contralateral stroke within 6 months after enrollment
Contralateral ischemic/hemorrhagic stroke within 6 months after enrollment.
Measured: 6 months
Ischemic driven qualifying artery revascularization within 6 months after enrollment
Ischemic driven qualifying artery revascularization within 6 months after enrollment.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
Any ipsilateral stroke or death within 12 months after enrollment
Ipsilateral ischemic/hemorrhagic stroke or all-cause death within 12 months after enrollment.
Measured: 12 months
Any contralateral stroke within 12 months after enrollment
Contralateral ischemic/hemorrhagic stroke within 12 months after enrollment.
Measured: 12 months
Ischemic driven qualifying artery revascularization within 12 months after enrollment
Ischemic driven qualifying artery revascularization within 12 months after enrollment.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Any ipsilateral stroke or death within 24 months after enrollment
Ipsilateral ischemic/hemorrhagic stroke or all-cause death within 24 months after enrollment.
Measured: 24 months
Any contralateral stroke within 24 months after enrollment
Contralateral ischemic/hemorrhagic stroke within 24 months after enrollment.
Measured: 24 months
Ischemic driven qualifying artery revascularization within 24 months after enrollment
Ischemic driven qualifying artery revascularization within 24 months after enrollment.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
Any ipsilateral stroke or death within 36 months after enrollment
Ipsilateral ischemic/hemorrhagic stroke or all-cause death within 36 months after enrollment.
Measured: 36 months
Any contralateral stroke within 36 months after enrollment
Contralateral ischemic/hemorrhagic stroke within 36 months after enrollment.
Measured: 36 months
Ischemic driven qualifying artery revascularization within 36 months after enrollment
Ischemic driven qualifying artery revascularization within 36 months after enrollment.
Measured: 36 months
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.
Measured: 36 months
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.
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiming Deng, Beijing Tiantan Hospital
- Investigators
- Zhongrong Miao, MD, Principal investigator, Beijing Tiantan HospitalNing Ma, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886775
- Sponsor's protocol ID
- HX-A-2026062
- Acronym
- OASIS-C
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No