An interventional study of Stenting plus medical therapy and Medical therapy alone in ICAS - Intracranial Atherosclerosis, sponsored by Changhai Hospital. Not yet recruiting. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment
A multicenter, open-label, blinded-endpoint, prospective, randomized controlled clinical trial with an "all comers" design.
The main objective of this study is to investigate the impact of angiography-derived fractional flow (Angio-FF) on diagnostic and therapeutic decision-making in patients with symptomatic intracranial atherosclerotic stenosis (sICAS). The study aims to evaluate whether stenting plus medical therapy, compared to medical therapy alone, can benefit patients selected through Angio-FF screening.
For Group A, patients with significant stenosis and hemodynamic impairment identified through Angio-FF (≤0.7) screening are expected to have a higher risk. The patients will be enrolled in RCT trial, with a planned enrollment of 336 subjects.
For Group B, patients with significant stenosis but without hemodynamic impairment identified through Angio-FF (>0.7) screening will be included in the registry cohort, with a planned enrollment of 200 subjects.
97 studies on the registry are indexed under Intracranial Arteriosclerosis; 43 are open to participants now.
This study's planned enrollment of 536 is above the median of 180 across 59 interventional studies indexed under Intracranial Arteriosclerosis.
Browse Intracranial Arteriosclerosis studies →Changhai Hospital is the lead sponsor of 354 studies on the registry; 136 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Stenting plus medical therapy
Combination Product: Stenting plus medical therapy
Medical therapy alone
Drug: Medical therapy alone
Patients randomized to intervention group received the percutaneous transluminal balloon angioplasty with stenting within 5 days after randomization, and loading dose of aspirin and clopidogrel was allowed. Received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after procedure.
Medical therapy alone: received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after randomisation.
Stroke or death
Stroke or death within 30 days after enrollment; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 30 days and 1 year.
Time frame: Stroke or death within 30 days after enrollment; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 30 days and 1 year.
Ischemic stroke in the target vessel territory
Ischemic stroke in the target vessel territory
Time frame: Within 1-3 years after enrollment
Ischemic stroke in non-target vessel territory
Ischemic stroke in non-target vessel territory
Time frame: Within 30 days to 1 year, and within 1-3 years after enrollment
Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
Time frame: Within 30 days to 3 years after enrollment
Any cause of death
Any cause of death
Time frame: Within 30 days to 3 years after enrollment
mRS score
Modified Rankin scale (mRS) score. The value range 0-6: higher scores mean a worse outcome.
Time frame: At 1 year, 2 years, and 3 years after enrollment
National Institutes of Health Stroke Scale (NIHSS) score
Stroke severity (NIHSS score). The value range 0-42: higher scores mean a worse outcome.
Time frame: At 1 year, 2 years, and 3 years after enrollment
Barthel Index
An ordinal scale which measures a person's ability to complete activities of daily living. The value range 0-100: higher scores mean a better outcome.
Time frame: At 1 year, 2 years, and 3 years after enrollment
No study locations are listed for this record.
Plan to share: Yes — Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data sharing will be available from 12 months after the publication of the main results.
Access criteria: The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses
Data sharing details ↗ · www.ocin.org.cn
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Intracranial Arteriosclerosis →