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A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy

ConditionsAISICAS - Intracranial AtherosclerosisStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChanghai Hospital

About this trial

A prospective, multicenter, randomized controlled, open-label, blinded outcome evaluation (PROBE) trial

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

National Institutes of Health Stroke Scale (NIHSS) score ≥6 before randomization

To receive mechanical thrombectomy <24 hours after AIS onset according to local guidelines

Signed informed consent form obtained from the subject (or approved surrogate)

Disqualifiers

Pre-stroke mRS >2

Intracranial hemorrhage confirmed by CT before mechanical thrombectomy and enrolment

Suspected Intracranial hemorrhage after successful recanalization confirmed by 3D-CT

Tandem lesions: stenosis (or occlusion) of the extracranial segment of the internal carotid artery or vertebral artery combined with occlusion of large intracranial vessels, stenosis of intracranial arteries combined with occlusion of vessels distal to the stenosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • balloon dilatation and/or stenting

    Device

    balloon dilatation and/or stenting immediately after randomization

  • medication

    Drug

    medication after randomisation, mechanical thrombectomy again if necessary, avoiding balloon dilatation and/or stenting.

Treatment groups

612 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional recovery

defined as a sequence shift (improvement) in scores on the mRS

Time frame
90(±14) days

Secondary outcomes

1

Rate of good functional outcome

mRS of 0-2

Time frame
90 (±14) days
2

Rate of excellent functional outcome

mRS 0-1

Time frame
90(±14) days
3

Change in stroke severity (NIHSS score)

Time frame
24±12 hours
4

Change in stroke severity (NIHSS score)

Time frame
7±2 days or discharge

Other outcomes

1

Deaths

Time frame
within 90±14 days after enrolment
2

Intracranial hemorrhage

Time frame
at 7 days post treatment or discharge (whichever occurs first)
3

SAEs

Time frame
within 90±14 days after enrolment
4

Any procedural complications

Time frame
Perioperative period

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changhai Hospital

Lead sponsor

The First People's Hospital of Changzhou

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: