Therapeutic Effect of Blood Flow Reconstruction in IVADA

NCT06134557 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-02-23

No results posted yet for this study

Summary

IVADA (Intracranial vertebral artery dissecting aneurysms)is one of the causes of subarachnoid hemorrhage or posterior circulation ischemia with high mortality and disability. Current endovascular therapies for IVADA mainly include parent artery occlusion and endovascular blood reconstructive techniques. The method of parent artery occlusion requires the sacrifice of one vertebral artery. For the IVADA patients whose dissection involves PICA(posterior inferior cerebellar artery)or anterior spinal artery, severe ischemia even infarction of brain stem or cerebellar may be caused after parent artery occlusion , they are usually irreversible damage, so that method are rarely used now.Endovascular flood reconstructive techniques has become the mainstream, including stent-alone or overlapping stent treatment ,stent-assisted coiling techniques, single flow diverter(FD) stents or flow diverter assisted coil, etc.With the improvements in stents, flow diverter stent is efficient, while they are associated with the risk of ischemia, especially when vital arterial branches are covered. It has been reported that FD techniques have certain advantages over traditional stents in the treatment of anterior circulating intracranial aneurysms. In the treatment of posterior circulating aneurysms, perioperative ischemic complications increase due to their influence on the blood flow of perforator arteries, but there are few long-term observations at present. Currently, studies directly contrasting flow diverter and conventional stents in patients with IVADA are rare. Therefore, we performed the study to compare the safety and efficacy between flow diverters and conventional stents in IVADA patients undergoing endovascular therapy. Stent-assisted coiling is the preferred option for most surgeons. In addition,It is believed that dense packing is not necessary as long as the aneurysm neck is covered to isolate the dissection. How ever,whether it is really necessary to adjunct coil,and if it is necessary, what is the ideal packing density of coils, there is no clear conclusion at present.This study aimed to compare the safety and efficacy between flow diverter and conventional stents in patients with IVADA, determine the ideal packing density of coils after FD stent placement,and to observe the hemodynamic changes before and after the treatment of FD stent.

Conditions

  • Intracranial Aneurysm

Interventions

PROCEDURE

conventional stents

performed the study to compare the safety and efficacy between flow diverters and conventional stents in IVADA patients undergoing endovascular therapy. Stent-assisted coiling is the preferred option for most surgeons. In addition,It is believed that dense packing is not necessary as long as the aneurysm neck is covered to isolate the dissection. How ever,whether it is really necessary to adjunct coil,and if it is necesary, what is the ideal packing density of coils, there is no clear conclusion at present.This study aimed to compare the safety and efficacy between flow diverter and conventional stents in patients with IVADA, determine the ideal packing density of coils after FD stent placement,and to observe the hemodynamic changes before and after the treatment of FD stent.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Yunyan Wang · Medical Ethics Committee of Qilu Hospital of Shandong University

  • Weiying Zhong · Medical Ethics Committee of Qilu Hospital of Shandong University

  • Maogui li · Medical Ethics Committee of Qilu Hospital of Shandong University

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2023-12-31
Completion
2024-02-28

Countries

  • China

Study Locations

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Read the full study record

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View NCT06134557 on ClinicalTrials.gov