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

NCT07886775 | Not Yet Recruiting DMC

• 1 other identifier: HX-A-2026062
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Stenosis

Keywords

Carotid Stenosis; Angioplasty

Outcome Measures

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.

  6 months

Secondary Outcomes (29)

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

  30 days

• Any ipsilateral stroke or death within 3 months after enrollment

  3 months

• Any contralateral stroke within 3 months after enrollment

  3 months

• Neurological improvement assessed by mRS at 3 months

  3 months

• Any ipsilateral stroke or death within 6 months after enrollment

  6 months

Study Arms (1)

OCT guided endovascular treatment

EXPERIMENTAL

All the participants will undergo endovascular treatment guided by OCT.

Procedure: OCT guided endovascular treatment

Interventions

OCT guided endovascular treatment PROCEDURE

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

OCT guided endovascular treatment

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhongrong Miao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Ning Ma, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiming Deng, MD

CONTACT

13910172189; dengyiming@bjtth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)