Intracranial aneurysm
Conditions
Interventions
Clinical trial group:TRA embolization of intracranial aneurysms
Clinical control group:TFA embolization of intracranial aneurysms
Sponsors
Nanjing Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University,
Nanjing, China
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: ? 18 years old = age = 80 years old, regardless of gender; ? Single intracranial aneurysm confirmed by preoperative MRA, CTA, or DSA and planned for coil embolization treatment; ? Hunt Hess grade of Subarachnoid hemorrhage = Grade III; ? The radial artery and Femoral artery can obviously touch the pulsation. At the same time, Allen test or Barbeau test showed that the radial ulnar artery compensated well, or the forearm vascular ultrasound confirmed that the radial artery and ulnar artery were well developed before surgery; ? The subject or their guardian can understand the purpose of the trial, have sufficient compliance with the protocol, and sign an informed consent form; ? There is no birth plan within half a year after signing the informed consent, or the Pregnancy test of women of childbearing age is negative.
Exclusion criteria
Exclusion criteria: ? Multiple intracranial aneurysms, aneurysms requiring Flow Diverter (FD) implantation; ? The diagnosis was blood blister-like aneurysm (BBA), pseudoaneurysm, infected aneurysm or aneurysm related to arteriovenous malformation; ? Researchers believe that severe stenosis or tortuosity of intracranial arteries or anatomical abnormalities make it difficult for the estimated instrument to reach the lesion site; ? Platelets (PLT)<60 × 109/L or contraindicated for antiplatelet or/or anticoagulant therapy; ? Heart, lung, liver and kidney failure or other serious diseases (such as intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, serious psychiatric history, severe cerebral blood supply artery stenosis or occlusion, etc.); ? The researcher assessed that the expected lifespan is less than 12 months and is unable to complete the research cycle; ? Pregnant or lactating women, or men or women with fertility plans within the next year; ? Patients who have been determined by researchers to be unsuitable for embolization treatment of intracranial aneurysms due to various reasons; ? Patients who are participating in other drug or device studies; ? The patient refuses to sign the informed consent form, or is unable to cooperate in completing the required examinations and follow-up, or in other situations where the researcher determines that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aneurysm occlusion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Aneurysm recurrence rate;Success rate of cerebral angiography;Patient comfort evaluation;Duration of surgical procedure;X-ray exposure;Incidence of intraoperative aneurysm rupture;The incidence of occlusion of the parent artery;Incidence of stroke;All-cause mortality;Adverse event occurrence rate;Serious adverse event occurrence rate;Adverse event of special interest occurrence rate; | — |
Countries
China
Contacts
Public ContactZhang Xin
Nanjing Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Outcome results
None listed