- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07707076
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)
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Huibin Kang, MD
- Telefonní číslo: +8602062787842
- E-mail: kanghuibindoctor@163.com
Studijní záloha kontaktů
- Jméno: Wenfeng Feng, MD
- Telefonní číslo: +8602062787665
- E-mail: fengwf1967@163.com
Studijní místa
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Guangdong
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Guangzhou, Guangdong, Čína, 510515
- Nábor
- Nanfang Hospital, Southern Medical University
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Kontakt:
- Wenfeng Feng, MD
- Telefonní číslo: +8602062787665
- E-mail: fengwf1967@163.com
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Kontakt:
- Huibin Kang, MD
- Telefonní číslo: 13520296286
- E-mail: kanghuibindoctor@163.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion 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.
Exclusion Criteria:
- 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/interventional procedure within 3 months;
- Patients deemed unsuitable for interventional 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 illness;
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 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.
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Experimentální: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of complications at 1 year postoperatively in patients treated with different modalities.
Časové okno: 1 year
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Any stroke, all-cause death events within 1 year post-surgery. Definitions:
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1 year
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Aneurysm occlusion rate and stability rate after different treatment modalities.
Časové okno: 5 years
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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
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
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- O'Kelly CJ, Spears J, Chow M, Wong J, Boulton M, Weill A, Willinsky RA, Kelly M, Marotta TR. Canadian experience with the pipeline embolization device for repair of unruptured intracranial aneurysms. AJNR Am J Neuroradiol. 2013 Feb;34(2):381-7. doi: 10.3174/ajnr.A3224. Epub 2012 Aug 2.
- Becske T, Potts MB, Shapiro M, Kallmes DF, Brinjikji W, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. J Neurosurg. 2017 Jul;127(1):81-88. doi: 10.3171/2015.6.JNS15311. Epub 2016 Oct 14.
- Jiang Chunyu, Wang Jianbo: Application of flow diverter in interventional treatment of intracranial aneurysms. Journal of Interventional Radiology 2014, 23(3):267-271
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- Cagnazzo F, Limbucci N, Nappini S, Renieri L, Rosi A, Laiso A, Tiziano di Carlo D, Perrini P, Mangiafico S. Y-Stent-Assisted Coiling of Wide-Neck Bifurcation Intracranial Aneurysms: A Meta-Analysis. AJNR Am J Neuroradiol. 2019 Jan;40(1):122-128. doi: 10.3174/ajnr.A5900. Epub 2018 Dec 6.
- Kashkoush A, El-Abtah ME, Petitt JC, Glauser G, Winkelman R, Achey RL, Davison M, Abdulrazzak MA, Hussain SM, Toth G, Bain M, Moore N. Flow diversion for the treatment of intracranial bifurcation aneurysms: a systematic review and meta-analysis. J Neurointerv Surg. 2024 Aug 14;16(9):921-927. doi: 10.1136/jnis-2023-020582.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
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