AcoArt sICAS: DCB in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis (NCT04631055) | Clinical Trial Compass
CompletedNot Applicable
AcoArt sICAS: DCB in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
China180 participantsStarted 2021-06-04
Plain-language summary
The purpose of the RCT trial is to determine whether DCB is not inferior to stent in treating intracranial stenosis.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 to 80 years of age;
* Patients with symptomatic intracranial atherosclerotic stenosis;
* Patients with intracranial arterial de novo stenosis confirmed by digital subtraction angiography (DSA);
* Confirmed by DSA,the diameter of the target vessel is between 2.5mm-4.5mm ; according to WASID method, the degree of stenosis of the target lesion is 70%-99%;
* Baseline mRS score ≤2;
* Voluntarily participate in this study and sign the informed consent form.
Exclusion Criteria:
* Patients with stroke within 2 weeks before procedure;
* Patients with stroke caused by perforating artery occlusion;
* Any history of brain parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 30 days;
* Those who have received thrombolysis within 24 hours before procedure;
* Deterioration of neurological function within 24 hours before procedure (defined as NIHSS score increased by ≥ 4 points over the baseline);
* The vascular path showed in angiography is so tortuous that it is difficult to advance catheters to the target lesion or retrieve;
* Lesions that investigators believe are not suitable for stenting;
* Patients with thrombus in target vessel;
* In addition to the target lesion, there are still other de novo lesion or ISR lesion with more than 70% diameter stenosis in intracranial arteries that need to be treated at the same time;
* After endovascular treatment of the target lesion, there is still a stenosis of more than 50% in th…
What they're measuring
1
Primary efficacy endpoint: Angiographic restenosis of the target lesion
Timeframe: 6 months post-procedure
2
Primary safety endpoint: Target vessel stroke or death event