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Flow Diverter Versus Conventional Endovascular Treatment for Unruptured Wide-Neck Bifurcation Aneurysms (FD-BWA Trial) (FD-BWA)

Traditional Approach Versus Flow Diverter for Unruptured Intracranial Wide-neck Bifurcation Aneurysms: a Prospective International Multicenter Randomized Controlled Study (FD-BWA Study)

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. The main questions it aims to answer are:

  • Does the traditional approach result in a lower rate of any stroke or all-cause death within one year after treatment compared to the flow diverter?
  • What medical problems do participants experience during and after each treatment?
  • What are the imaging cure and stability rates at 1, 2, and 5 years after treatment?

Researchers will compare the traditional approach (stent-assisted coiling) with the flow diverter (Pipeline™) to determine which treatment has better safety and efficacy outcomes.

Participants will:

  • Be randomly assigned to receive either the flow diverter or traditional stent-assisted coiling
  • Undergo the assigned endovascular procedure
  • Return for follow-up visits at 30 days, 6 months, 1 year, 2 years, and 5 years after surgery for clinical assessments and imaging examinations (DSA, MRA, or CTA)

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

266

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Guangdong
      • Guangzhou, Guangdong, Kina, 510515
        • Rekruttering
        • Nanfang Hospital, Southern Medical University
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age 18-75 years;
  2. Diagnosis of unruptured intracranial, bifurcation, saccular, wide-neck aneurysm by DSA/CTA/MRA;
  3. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form.

Exclusion Criteria:

  1. Patients with two or more multiple aneurysms that all require treatment within 1 year;
  2. Concomitant cerebrovascular diseases such as arteriovenous malformation, moyamoya disease;
  3. Ruptured aneurysms and narrow-neck aneurysms;
  4. Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 1 month;
  5. Extremely poor clinical condition, modified Rankin Score ≥3;
  6. Patients already scheduled for surgery/interventional procedure within 3 months;
  7. Patients deemed unsuitable for interventional treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficulty delivering stent);
  8. 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 illness;
  9. Patients unable to receive antiplatelet or anticoagulant therapy;
  10. Patients who have had or may have severe reactions to contrast media precluding pre-treatment medication;
  11. Patients with a definite history of allergy to cobalt-chromium, nickel-titanium alloy materials;
  12. Participation in other drug or medical device clinical trials before enrollment without reaching the primary endpoint timeframe;
  13. Pregnant or breastfeeding women;
  14. Patient's life expectancy less than 12 months;
  15. Investigator judges that the patient has poor compliance and cannot complete the study as required.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Stent Assisted Coiling Group

Traditional Group (Stent Assisted Coiling):

The patient is placed in a supine position. After satisfactory general anesthesia, the right groin area is routinely disinfected and draped. The right femoral artery sheath is replaced with an 8F sheath. Systemic heparinization is administered, followed by continuous pressurized infusion. A 6F long sheath plus a 5F multifunction catheter are advanced with a Terumo guidewire, and the long sheath is positioned in the left vertebral artery. A micro guidewire is used with a microcatheter to selectively catheterize the left posterior cerebral artery P2 segment, and then the microcatheter is advanced into the aneurysm. Through the microcatheter, one coil is semi deployed to form a framing coil, then one stent is deployed through the stent catheter to cover the aneurysm neck. After the first framing coil is detached, several additional coils are sequentially deployed to embolize the aneurysm. Follow up angiography shows no opacification of the a

Stent-assisted coiling for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the control group.
Eksperimentel: Flow Diverter Group

Flow Diverter Group:

The patient is placed in a supine position. The right groin area is routinely disinfected and draped. Local infiltration anesthesia is applied at the puncture site, and the right femoral artery is punctured using the Seldinger technique. An 8F sheath is inserted, systemic heparinization is administered, and continuous pressurized infusion is started. A 6F long sheath is advanced to the origin of the right internal carotid artery with the assistance of a Terumo guidewire and a multifunction catheter. A 5F intermediate catheter is advanced inside the long sheath to the petrous segment of the right internal carotid artery. 3D cerebral angiography is performed, and after a suitable working angle is obtained, a stent catheter is advanced to the right middle cerebral artery M3 segment with micro guidewire assistance. Manual injection shows no hemorrhage, confirming the true lumen. After calibration and measurement, one flow diverter stent is deployed to cover the ane

Flow diversion with the Pipeline™ (Flex/Shield) device for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the experimental group.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of complications at 1 year postoperatively in patients treated with different modalities.
Tidsramme: 1 year

Any stroke, all-cause death events within 1 year post-surgery.

Definitions:

  1. Stroke defined as: acute focal or global neurological dysfunction due to vascular injury of brain, spinal cord or retina caused by hemorrhage or infarction, symptom duration ≥24 hours, including symptomatic branch stenosis/occlusion due to branch coverage;
  2. TIA: transient focal neurological dysfunction due to brain, spinal cord or retinal ischemia, symptom duration <24 hours, without acute infarction;
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Aneurysm occlusion rate and stability rate after different treatment modalities.
Tidsramme: 5 years

Imaging cure rate (Raymond-Roy grade I) at 1, 2, and 5 years post-surgery.

Definitions:

Raymond-Roy grade: Class I: complete occlusion, no contrast filling in sac or neck; Class II: neck remnant, sac obliterated, contrast in neck; Class III: aneurysm remnant, contrast in sac.

5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. februar 2026

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

30. juni 2030

Datoer for studieregistrering

Først indsendt

29. marts 2026

Først indsendt, der opfyldte QC-kriterier

10. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

clinical and imaging data

IPD-delingstidsramme

2025.06.01-2030.06.31

IPD-delingsadgangskriterier

Principal Investigators at each study center

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Stent Assisted Coiling Group

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