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Can a new eye on blocked carotid arteries make stroke treatment safer?

NCT ID NCT07740408

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial tests whether using optical coherence tomography (OCT) during a procedure to reopen a chronically blocked carotid artery is safe. The blockage can cause strokes, and doctors often need to see what's inside the artery after crossing the blockage. OCT provides high-resolution images that might help identify clots or other problems better than standard X-rays. The study will enroll 60 adults with symptomatic carotid artery occlusion who are already planned for this procedure, and it will track complications like vessel injury, bleeding, or kidney issues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Optical coherence tomography (OCT) imaging during endovascular recanalization
What this could lead to
If OCT proves safe and useful, it could help doctors better see and treat blockages in the carotid artery, potentially reducing stroke risk and improving outcomes for patients with chronic carotid artery occlusion.
What could go wrong
This is a small, early-stage safety study, so the benefits are uncertain. The procedure carries risks like vessel injury, bleeding, or kidney damage from contrast dye, and OCT may not improve outcomes enough to change practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include adults with symptomatic chronic carotid artery occlusion who are planned for clinically indicated endovascular recanalization and in whom OCT imaging can be performed after the guidewire crosses the occluded segment or after an imaging-capable working channel is established. CCAO will be confirmed by preoperative clinical assessment, including ipsilateral transient ischemic attack or ischemic stroke history and imaging evidence of ipsilateral hypoperfusion, together with noninvasive vascular imaging by CTA or MRA. Atherosclerosis should be the main suspected etiology, with an occlusion duration of at least 3 weeks. Intra-procedural DSA will confirm occlusion morphology before OCT imaging is performed.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-80 years, male or female. 2. Symptomatic chronic carotid artery occlusion, with atherosclerosis as the main etiology and disease duration of at least 3 weeks. 3. Persistent symptoms despite best medical therapy, including ipsilateral TIA or stroke, or imaging evidence of ipsilateral hypoperfusion. 4. Clinically planned endovascular recanalization procedure in which the guidewire successfully crosses the occluded segment. 5. Intra-procedural OCT intraluminal imaging is planned or completed. 6. The operator judges that OCT imaging will not substantially increase immediate rescue risk and that peri-procedural safety observation can be completed. 7. Baseline mRS score 0-2, NIHSS \<=15, and ASPECTS \>=6. 8. Target vessel anatomy can support endovascular recanalization and stent therapy if clinically necessary. 9. Written informed consent has been signed before the procedure and includes OCT imaging and follow-up requirements. Exclusion Criteria: * 1.Intra-procedural clinical condition requires immediate rescue treatment, preventing protocol-defined OCT imaging or safety recording. 2.Flow-limiting dissection, vascular rupture, or another serious complication requiring immediate rescue treatment occurs before OCT examination. 3.Non-atherosclerotic etiology, including arterial dissection, moyamoya disease, vasculitis, or radiation-induced vascular injury. 4.Ipsilateral intracranial large vessel occlusion requiring priority treatment. 5.Severe coagulation disorder, including platelet count \<80 x 10\^9/L or INR \>2.0. 6.Known contraindication or severe allergy to iodinated contrast, required peri-procedural antithrombotic medication, or OCT-related flushing or contrast procedures. 7.Large cerebral infarction, defined as ASPECTS \<6 or DWI infarct volume \>70 mL. 8.Severe target vessel calcification or tortuosity such that the OCT catheter is not expected to pass safely or the recanalization risk is judged to be extremely high. 9.eGFR \<30 mL/min or severe hepatic dysfunction. 10.Life expectancy \<12 months. 11.Pregnancy or lactation. 12.Current participation in another conflicting clinical study that may affect outcome assessment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Renji Hospital

    Shanghai, Shanghai Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.