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

NCT06448949 | Recruiting DMC

• 1 other identifier: LC20240520
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

Study Arms (1)

TB and PED

Other: Flow Diverter Implantation

Interventions

Flow Diverter Implantation OTHER

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.

TB and PED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

DuanChuanzhi

Guangzhou, Guangdong, 528400, China

RECRUITING

Study Officials

• Duan Chuan zhi, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Xin, MD

CONTACT

15989058895; zhangxin19830818@163.com

Jia Zhi kun, MMed

CONTACT

16638161220; 1239717402@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: June 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)