Hemodynamic Study of In-Stent Stenosis(I) After Flow Diverter(F) Based on 3D-DSA(D) Combined With TCCD(T) (DTFI)

Hemodynamic Study of In-Stent Stenosis After Flow Diverter Implantation for Intracranial Aneurysms Based on 3D-DSA Combined With TCCD

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodynamics;In-stent Stenosis;Transcranial Doppler;Intracranial Aneurysm;Flow Diverter; Prospective Cohort Study
• Intervention / Treatment: Other: Flow Diverter Implantation

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Zhang Xin, MD; Phone Number: 15989058895; Email: zhangxin19830818@163.com
• Study Contact Backup: Name: Jia Zhi kun, MMed; Phone Number: 16638161220; Email: 1239717402@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 528400
      • Recruiting
      • DuanChuanzhi
      • Contact: Zhang Xin, MD; Phone Number: 15989058895; Email: zhangxin19830818@163.com
      • Contact: Jia Zhi kun, MMed; Phone Number: 16638161220; Email: 1239717402@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TB and PED	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with Symptomatic intracranial hemorrhage(sICH) within 48 hours	ICH will be evaluated according to the Heidelberg Bleeding Classification. sICH is diagnosed if the new observed ICH is associated with any of the following conditions: 1) NIHSS score increased more than 4 points than that immediately before worsening; 2) NIHSS score increased more than 2 points in one category; 3) Deterioration led to intubation, hemicraniectomy, external ventricular drain placement or any other major interventions. Additionally, the symptom deteriorations could not be explained by causes other than the observed ICH.	Within 48 hours
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	Transcranial Color-Coded Doppler (TCCD) measurements of blood flow velocity	Preoperatively, 3 days postoperatively, and 6 months postoperatively
Hemodynamic changes in-stent stenosis	Transcranial Color-Coded Doppler (TCCD) measurements of blood flow velocity	Preoperatively, 3 days postoperatively, and 6 months postoperatively
The occlusion rate of the aneurysm	The occlusion rate of the aneurysm at 6 months	6 months
Proportion of patients without disability at 6 months	mRS score 0-1	6 months
Proportion of patients with functional independence at 6 months	mRS score 0-2	6 months
Incidence of serious adverse events	Including but not limited to acute respiratory failure, severe or malignant cerebral artery infarction, acute heart failure, debridement decompression, and other major medical events that can result in death, immediately life-threatening, hospitalization or prolongation of this hospitalization, terminally or severely disabling/incapacitating, the loss of a significant ability to maintain normal life functioning, or medical intervention to avoid the above outcomes.	Within 1 years
Procedure-related complications Procedure-related complications	such as arterial perforation, iatrogenic arterial dissection, embolization in previously uninvolved vascular territory, arterial access site hematoma, and retroperitoneal hematoma. Arterial perforation will be defined at angiography by the operator and associated with subarachnoid hemorrhage. Iatrogenic arterial dissection will be defined at angiography by the operator. Arterial access site hematoma will be assessed as a complication of arterial access puncture and defined by clinical examination and anatomic imaging. Retroperitoneal hematoma will be assessed as a complication of groin puncture and defined by imaging (ultrasound or CT or MR angiography). The definition of embolization in previously uninvolved vascular territory is noted after recanalization of the primary occlusion site, any vessel occlusions distal from the primary occlusion site are considered emboli due to periprocedural thrombus fragmentation.	Up to 24 hours

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Principal Investigator: Duan Chuan zhi, MD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Hemodynamics.in-stent stenosis.Transcranial Doppler.Intracranial Aneurysm.flow diverter.Prospective cohort study.Mechanical thrombectomy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Intracranial Arterial Diseases; Constriction, Pathologic; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: LC20240520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No