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Compares treatment options for Intracranial Aneurysm
Official title General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter
ClinicalTrials.gov ID: NCT06416657
What this study is testing
- What it's testing
- The prevalence of unruptured intracranial aneurysm (UIA) in the population is about 2%-7%, and once it ruptures and bleeds, the rate of disability and death is extremely high, with 10%-15% of patients dying suddenly before they can seek medical attention, 35% of first-time bleeders, and 60%-80% of second-time bleeders. Survivors are often disabled.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age ≥18 years old and ≤80 years old, gender is not limited;
- Patients with previously untreated unruptured intracranial aneurysm (UIA) clearly diagnosed by DSA, CTA, or MRA;
- UIA maximum diameter \<15mm;
- Baseline mRS score ≤2;
- UIAs planned for treated with PED;
You likely can't join if
- The aneurysms are located distal to the anterior cerebral artery (including the anterior communicating artery), distal to the M2 segment of the...
- Those who are allergic to any components of the anesthetic drugs;
- Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3;
- Pregnant and lactating female patients;
- Severe hepatic dysfunction (ALT or AST \>three times the normal upper limit) or severe renal dysfunction (creatinine clearance rate \<30 mL/min)...
- Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable...
See the full eligibility criteria
- Age ≥18 years old and ≤80 years old, gender is not limited;
- Patients with previously untreated unruptured intracranial aneurysm (UIA) clearly diagnosed by DSA, CTA, or MRA;
- UIA maximum diameter \<15mm;
- Baseline mRS score ≤2;
- UIAs planned for treated with PED;
- Patients voluntarily participated in this study and signed an informed consent form.
- The aneurysms are located distal to the anterior cerebral artery (including the anterior communicating artery), distal to the M2 segment of the middle cerebral artery, and distal to the basilar artery;
- Those who are allergic to any components of the anesthetic drugs;
- Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3;
- Pregnant and lactating female patients;
- Severe hepatic dysfunction (ALT or AST \>three times the normal upper limit) or severe renal dysfunction (creatinine clearance rate \<30 mL/min) before randomisation;
- Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable metal dentures, etc.);
- Patients known to suffer from dementia or psychiatric diseases and claustrophobia can not complete the magnetic resonance examination;
- Patients with other serious diseases combined at the time of diagnosis with an expected survival time of less than 1 year;
- Patients who are participating in clinical trials of other drugs or devices;
- Other conditions that, in the judgment of the investigator, exist that are unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.