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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

More Zhujiang Hospital trials in China