Clinical trial NCT06448949: Hemodynamic Study of In-Stent Stenosis(I) After Flow Diverter(F) Based on 3D-DSA(D) Combined With TCCD(T)
Official title: Hemodynamic Study of In-Stent Stenosis After Flow Diverter Implantation for Intracranial Aneurysms Based on 3D-DSA Combined With TCCD
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemodynamics;In-stent Stenosis;Transcranial Doppler;Intracranial Aneurysm;Flow Diverter; Prospective Cohort Study
Keywords: Hemodynamics.in-stent stenosis.Transcranial Doppler.Intracranial Aneurysm.flow diverter.Prospective cohort study.Mechanical thrombectomy
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in the Department of Neurovascular Surgery, Zhujiang Hospital, Southern Medical University, who were confirmed by DSA to have intracranial aneurysms and underwent treatment with FD (flow diverter) implantation.

Brief summary: DTFI is a single-center, prospective cohort study aimed at evaluating the hemodynamics of in-stent stenosis after flow diverter implantation, seeking to identify the threshold effect of blood flow in stenosis.

Detailed description: DTFI study investigates the hemodynamic changes in patients with intracranial aneurysms who have undergone flow diverter implantation, using a combination of three-dimensional digital subtraction angiography (3D-DSA) and transcranial color-coded duplex (TCCD) sonography. The aim is to understand the development of in-stent stenosis and its impact on blood flow.

Eligibility criteria: Inclusion Criteria:

Age ≥ 18, male or non-pregnant female. Diagnosis of intracranial aneurysm confirmed by DSA (Digital Subtraction Angiography).

Intracranial aneurysms treated with flow diverter (FD). DSA follow-up of at least 1 month.

Exclusion Criteria:

Secondary intracranial aneurysm cases: traumatic aneurysms, infectious aneurysms, or aneurysms associated with arteriovenous malformations (AVM) or vasculitis.

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.

Primary outcomes:
measure: operative Hemodynamic Differences ### Pre- and Post-operative Hemodynamic Differences ### Pre- and Post-operative Hemodynamic Differences ### Pre- and Post-operative Hemodynamic Differences ### Pre- and Post-operative Hemodynamic
timeFrame: Preoperatively, 3 days postoperatively, and 6 months postoperatively
measure: Hemodynamic changes in-stent stenosis
timeFrame: Preoperatively, 3 days postoperatively, and 6 months postoperatively
measure: The occlusion rate of the aneurysm
timeFrame: 6 months
measure: Proportion of patients without disability at 6 months
timeFrame: 6 months
measure: Proportion of patients with functional independence at 6 months
timeFrame: 6 months
measure: Proportion of patients with Symptomatic intracranial hemorrhage(sICH) within 48 hours
timeFrame: Within 48 hours
measure: Incidence of serious adverse events
timeFrame: Within 1 years
measure: Procedure-related complications Procedure-related complications
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: DuanChuanzhi
state: Guangdong
Study officials:
affiliation: Study Principal Investigator
name: Duan Chuan zhi, MD
role: PRINCIPAL_INVESTIGATOR
References: