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Optical Coherence Tomography-Assisted Strategy for Interventional Management of Symptomatic Carotid Stenosis (OASIS-C)
Condition(s) studied
Carotid Stenosis
Investigational drug(s) / intervention(s)
OCT guided endovascular treatment
OCT guided endovascular treatment: OCT guides carotid balloon angioplasty and/or stenting of the target artery.
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.
Eligibility
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:
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.
Primary outcome measure(s)
- 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
| Beijing Tiantan Hospital |
Beijing |
Beijing Municipality |
|
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