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
Sponsor study identifier
interventional
204
0 countries
N/A
Study Start
November 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 14, 2023
Actual (reported)November 20, 2023
Actual (reported)December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
6-month target lesion restenosis rate
6-month
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
Through the expansion after the balloon is in place, improve the blood perfusion of nerve vessels to treat stenosis.
First Submitted
November 14, 2023
First Posted
November 20, 2023
Study Start
November 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Extra Alirocumab in Addition to Statin Therapy in Symptomatic IntraCranial Atherosclerotic Stenosis ----a Pilot Study
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December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 20, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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