NCT06857058 - Standardized Procedure for Intracranial Drug-Eluting Stenting in the Treatment of Intracranial Atherosclerotic Stenosis | Syfrah

Trials Sponsors Conditions Drugs Pricing

Conditions

Intracranial Atherosclerotic Stenosis

Keywords

endovascular therapy, intracranial drug-eluting stent

Outcome Measures

Primary Outcomes (1)

Stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure.
This outcome includes ischemic/hemorrhagic stroke and all-cause death within 30 days after procedure of the qualifying lesion during follow-up, or any ischemic stroke and revascularization from the original culprit symptomatic intracranial artery beyond 30 days through 12 months after procedure.
1 year after procedure

Secondary Outcomes (12)

Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after procedure
30 days after procedure
Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after procedure
30 days after procedure
Rate of TIA at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
3, 6 months, 1, 2, 3, 4 years and 5 years after procedure

Study Arms (1)

NOVA DES

EXPERIMENTAL

Patients who met the inclusion criteria were implanted with the NOVA stent, and the procedure was documented in detail.

Device: NOVA DES

Interventions

NOVA DESDevice

The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon

NOVA DES

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Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males or females between 18 and 80 years of age
Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm

Sponsors & Collaborators

Sino Medical Sciences Technology Inc.
Industrylead
Tongji Hospital
Othercollaborator
The First Affiliated Hospital of Zhengzhou University

Study Sites (1)

The first affiliated hospital of zhengzhou university

Zhengzhou, China

RECRUITING

Sheng GuanCONTACT

Study Officials

Sheng Guan
The First Affiliated Hospital of Zhengzhou University
PRINCIPAL INVESTIGATOR
Chun Fang
Tongji Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Yu

CONTACT

18614030565 yuxiaoyan@sinomed.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 26, 2025

First Posted

March 4, 2025

Study Start

March 8, 2024

Actual (reported)

Primary Completion

June 8, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.