NCT07754188Toboroz
Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms
Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms: A Prospective Real-World Cohort Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 10.
Rövid összefoglaló (regiszter, angolul)
This prospective real-world cohort study aims to compare early postoperative complications between flow diverter treatment and stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. A total of 274 patients from three centers in China will be enrolled and assigned to the flow diverter group or the stent-assisted coiling group according to the treatment received in routine clinical practice. The primary outcome is a composite of any stroke or all-cause death within 30 days after the procedure. The study will also collect demographic, clinical, laboratory, imaging, aneurysm morphological, procedural, and follow-up data to evaluate the safety of these two endovascular treatment strategies in a real-world setting.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 274 (tervezett)
- Első benyújtás
- 2026. aug. 4.
- Kezdés
- 2026. márc. 19.
- Elsődleges befejezés
- 2027. márc. 19.
- Fő szponzor
- Nanfang Hospital, Southern Medical University
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT07754188
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 274
- 2026. márc. 19. és az elsődleges befejezés (2027. márc. 19.) között
- 3 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Patients who have already planned to undergo surgical or interventional treatment within 3 months.
- Patients unable to receive antiplatelet or anticoagulant therapy.
- Patients with a previous or possible severe reaction to contrast agents that would prevent completion of pre-treatment medication or treatment.
- Patients who participated in another drug or medical device clinical trial before enrollment and have not reached the time point of the primary endpoint.
Más betegség
- Patients with other cerebrovascular diseases such as arteriovenous malformation or moyamoya disease.
- Patients who experienced stroke, including cerebral hemorrhage or cerebral infarction, within the past 1 month.
- Patients with poor clinical condition, defined as modified Rankin Scale score ≥3.
- Patients unsuitable for anesthesia or endovascular treatment, including those with major heart, lung, liver, spleen, or kidney disease, brain tumor, severe active infection, disseminated intravascular coagulation, or a history of severe psychiatric disorder.
- Patients with a known history of allergy to cobalt-chromium or nickel-titanium alloy materials.
Egyéb
- Patients with two or more multiple aneurysms, all of which require treatment within 1 year.
- Patients with ruptured aneurysms or narrow-neck aneurysms.
- Patients considered by the investigator to be unsuitable for endovascular treatment, such as those with no suitable vascular access, excessively tortuous vessels, or difficulty in stent delivery.
- Pregnant or lactating women.
- Patients with life expectancy less than 12 months.
- Patients judged by the investigator to have poor compliance and inability to complete the study as required
Kiket keres a vizsgálat
- Voluntarily provides written informed consent.
- Aged 18 to 75 years.
- Diagnosed by CTA, MRA, or DSA as having an unruptured, bifurcation, saccular, wide-neck intracranial aneurysm.
- Able to understand the purpose of the study.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Zhujiang Hospital, Southern Medical University | Guangzhou | Kína | Toboroz |
| Nanfang Hospital, Southern Medical University | Guangzhou | Kína | Toboroz |
| Guangdong Province People's Hospital | Guangzhou | Kína | Toboroz |
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