Hemodynamic Study of In-Stent Stenosis(I) After Flow Diverter(F) Based on 3D-DSA(D) Combined With TCCD(T)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flow Diverter Implantation.
- Who it may be relevant to
- Registry conditions: Hemodynamics;In-stent Stenosis;Transcranial Doppler;Intracranial Aneurysm;Flow Diverter; Prospective Cohort Study. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hemodynamic Study of In-Stent Stenosis After Flow Diverter Implantation for Intracranial Aneurysms Based on 3D-DSA Combined With TCCD
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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 [Time frame: Preoperatively, 3 days postoperatively, and 6 months postoperatively]
- Hemodynamic changes in-stent stenosis [Time frame: Preoperatively, 3 days postoperatively, and 6 months postoperatively]
- The occlusion rate of the aneurysm [Time frame: 6 months]
- Proportion of patients without disability at 6 months [Time frame: 6 months]
- Proportion of patients with functional independence at 6 months [Time frame: 6 months]
- Proportion of patients with Symptomatic intracranial hemorrhage(sICH) within 48 hours [Time frame: Within 48 hours]
- Incidence of serious adverse events [Time frame: Within 1 years]
- Procedure-related complications Procedure-related complications [Time frame: Up to 24 hours]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- DuanChuanzhi — Guangzhou
Identifiers
NCT: NCT06448949 · LC20240520