Hemodynamics;In-stent Stenosis;Transcranial Doppler;Intracranial Aneurysm;Flow Diverter; Prospective Cohort Study
Conditions
Keywords
Hemodynamics.in-stent stenosis.Transcranial Doppler.Intracranial Aneurysm.flow diverter.Prospective cohort study.Mechanical thrombectomy
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.
Interventions
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.
Sponsors
Zhujiang Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Preoperatively, 3 days postoperatively, and 6 months postoperatively | Transcranial Color-Coded Doppler (TCCD) measurements of blood flow velocity |
| Hemodynamic changes in-stent stenosis | Preoperatively, 3 days postoperatively, and 6 months postoperatively | Transcranial Color-Coded Doppler (TCCD) measurements of blood flow velocity |
| The occlusion rate of the aneurysm | 6 months | The occlusion rate of the aneurysm at 6 months |
| Proportion of patients without disability at 6 months | 6 months | mRS score 0-1 |
| Proportion of patients with functional independence at 6 months | 6 months | mRS score 0-2 |
| Proportion of patients with Symptomatic intracranial hemorrhage(sICH) within 48 hours | 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. |
| Incidence of serious adverse events | Within 1 years | 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. |
| Procedure-related complications Procedure-related complications | Up to 24 hours | 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. |
Countries
China
Contacts
Primary ContactZhang Xin, MD
Backup ContactJia Zhi kun, MMed
Outcome results
None listed