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Compares treatment options for Unruptured Intracranial Wide-neck Bifurcation Aneurysms
Official title Flow Diverter Versus Conventional Endovascular Treatment for Unruptured Wide-Neck Bifurcation Aneurysms (FD-BWA Trial)
ClinicalTrials.gov ID: NCT07707076
What this study is testing
- What it's testing
- Brief Summary： The goal of this clinical trial is to compare whether the traditional approach (stent-assisted coiling) is associated with a lower complication rate than flow diverter (Pipeline™) treatment for unruptured intracranial wide-neck bifurcation aneurysms. It will also evaluate the long-term imaging outcomes and safety of both treatments.
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 75
You may be able to join if
- Age 18-75 years;
- Diagnosis of unruptured intracranial, bifurcation, saccular, wide-neck aneurysm by DSA/CTA/MRA;
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form.
You likely can't join if
- Patients with two or more multiple aneurysms that all require treatment within 1 year;
- Concomitant cerebrovascular diseases such as arteriovenous malformation, moyamoya disease;
- Ruptured aneurysms and narrow-neck aneurysms;
- Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 1 month;
- Extremely poor clinical condition, modified Rankin Score ≥3;
- Patients already scheduled for surgery/treatment procedure within 3 months;
See the full eligibility criteria
- Age 18-75 years;
- Diagnosis of unruptured intracranial, bifurcation, saccular, wide-neck aneurysm by DSA/CTA/MRA;
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form.
- Patients with two or more multiple aneurysms that all require treatment within 1 year;
- Concomitant cerebrovascular diseases such as arteriovenous malformation, moyamoya disease;
- Ruptured aneurysms and narrow-neck aneurysms;
- Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 1 month;
- Extremely poor clinical condition, modified Rankin Score ≥3;
- Patients already scheduled for surgery/treatment procedure within 3 months;
- Patients deemed unsuitable for treatment treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficulty delivering stent);
- Patients unsuitable for anesthesia or endovascular surgery, such as major diseases of heart, lung, liver, spleen, kidney, brain tumors, severe active infections, disseminated intravascular coagulation, severe mental...
- Patients unable to receive antiplatelet or anticoagulant therapy;
- Patients who have had or may have severe reactions to contrast media precluding pre-treatment medication;
- Patients with a definite history of allergy to cobalt-chromium, nickel-titanium alloy materials;
- Participation in other drug or medical device clinical trials before enrollment without reaching the primary endpoint timeframe;
- Pregnant or breastfeeding women;
- Patient's life expectancy less than 12 months;
- Investigator judges that the patient has poor compliance and cannot complete the study as required.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.