Hemodynamic Study of In-Stent Stenosis(I) After Flow Diverter(F) Based on 3D-DSA(D) Combined With TCCD(T)
NCT ID: NCT06448949
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-06-01
2026-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TB and PED
Flow Diverter Implantation
Patients must undergo flow diverter implantation and have DSA examinations of the parent artery and TCCD examinations of Flow Diverter Implantation performed preoperatively, three days postoperatively, and six months postoperatively.
Interventions
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Flow Diverter Implantation
Patients must undergo flow diverter implantation and have DSA examinations of the parent artery and TCCD examinations of Flow Diverter Implantation performed preoperatively, three days postoperatively, and six months postoperatively.
Eligibility Criteria
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Inclusion Criteria
Intracranial aneurysms treated with flow diverter (FD). DSA follow-up of at least 1 month.
Exclusion Criteria
Previously treated recurrent aneurysm or target aneurysm with craniotomy clipping surgery or other endovascular interventions.
Aneurysms located at the distal end of the circle of Willis where TCCD (Transcranial Color-Coded Doppler) cannot be detected.
Known familial clustering history. Expected survival less than 1 year. Preoperative clinical assessment with mRS (Modified Rankin Scale) score ≥ 3. Known allergy or contraindication to antiplatelet drugs, anticoagulants, contrast agents, anesthetics, nitinol memory alloy, platinum-tungsten alloy, or platinum-iridium alloy.
Severe respiratory, hepatic, or renal disease (e.g., creatinine ≥ 3.0 mg/dL excluding dialysis) or coagulation disorders.
Undergoing major surgery (e.g., limb fracture fixation, tumor resection, major organ surgery, etc.) within 30 days prior to signing informed consent or planned within 60 days after signing informed consent.
Pregnant or lactating women, or women with a positive pregnancy test.
18 Years
ALL
No
Sponsors
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Zhujiang Hospital
OTHER
Responsible Party
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Principal Investigators
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Duan Chuan zhi, MD
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
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DuanChuanzhi
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LC20240520
Identifier Type: -
Identifier Source: org_study_id
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