Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drug balloon dilated, balloon dilated.
- Who it may be relevant to
- Registry conditions: Intracranial Atherosclerotic Stenosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of Biolimus-coated Intracranial Balloon Dilation Catheter Treatment of Patients With Symptomatic Intracranial Atherosclerotic Stenosis
Overview
This test took the target lesion restenosis rate 6 months after the operation as the main endpoint to verify the effectiveness of the intracranial balloon expansion catheter of Biolimus coating. After completing the follow-up 6 months after the operation, a clinical summary report was issued for the registration application of the product, and on this basis, 12 months of postoperative follow-up was carried out to evaluate the mid-term curative effect.
Interventions
- Device Drug balloon dilated
Through the expansion after the balloon is in place,Release drugs on the surface of the balloon and improve the blood perfusion of nerve vessels to treat stenosis - Device balloon dilated
Through the expansion after the balloon is in place, improve the blood perfusion of nerve vessels to treat stenosis.
Primary outcome measures
- 6-month target lesion restenosis rate [Time frame: 6-month]
Eligibility criteria
Inclusion criteria
- 18 to 80 years old;
- Symptomatic intracranial artery stenosis, and the degree of visual stenosis of target blood vessels under intracranial angiography is 70\~99%(WASID method);
Exclusion criteria
- Target blood vessels are seriously calcified and distorted, and it is difficult to put the interventional instruments in place or recover;
- Ischemic cerebral infarction occurred 3 weeks before surgery;
- Cerebral hemorrhage 3 months before operation;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06140550 · TP-NS-036