NCT06702657Not yet recruiting
A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy
A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy (ICAS LVO-MT)
Source: ClinicalTrials.gov · Last updated 18 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A prospective, multicenter, randomized controlled, open-label, blinded outcome evaluation (PROBE) trial
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 612 (estimated)
- First submitted
- 21 Nov 2024
- Start date
- 15 Mar 2025
- Primary completion date
- 15 Nov 2026
- Lead sponsor
- Changhai Hospital
- Diseases
- Stroke
- NCT number
- NCT06702657
What you commit to
- Study type: Interventional
- Planned participants: 612
- From 15 Mar 2025 to the primary completion date, 15 Nov 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery or serious trauma in the previous 2 weeks
- History of gastrointestinal or urinary bleeding in the previous 3 weeks
Other illness
- Pre-stroke mRS \>2
- Intracranial hemorrhage confirmed by CT before mechanical thrombectomy and enrolment
- Suspected Intracranial hemorrhage after successful recanalization confirmed by 3D-CT
- Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc.
- Contraindication for antiplatelet treatment or allergy to contrast agent
- Any other condition that, in the investigator's judgement, deems the individual unsuitable for enrolment.
Other
- 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
- More than two severe stenosis of the responsible occluded vessel (internal carotid artery, middle cerebral artery, vertebral artery, and basilar artery)
- Current use of oral anticoagulants
- Contraindication for mechanical thrombectomy or stenting angioplasty
- Life expectancy less than 1 years
- Current pregnant or breastfeeding status
- Currently participating in another clinical trial that may affect the outcome assessment of this trial
Who the study is looking for
- Clinical inclusion criteria:
- 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)
- Imaging inclusion criteria:
- For subjects with anterior circulation stroke, ASPECTS ≥6 based on CT or DWI
- For subjects with posterior circulation stroke, posterior circulation ASPECTS (pc-ASPECTS)≥6 and pons-midbrains index (PMI) \< 3 based on CT or DWI
- Angiography inclusion criteria:
- The responsible occluded vessel is immediately recanalized (eTICI≥2b) after mechanical thrombectomy, ICAS is highly suspected and the focal residual stenosis of the main trunk is≥70%, and the responsible occluded vessels include the intracranial segment of the internal carotid artery, the M1 segment of the middle cerebral artery, the V4 segment of the vertebral artery, and the basilar artery
- According to the judgment of the neurointerventional physician, the responsible artery is suitable for stenting angioplasty
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.