A Prospective Randomized Controlled Trial of Flow-diverting Devices for the Treatment of Middle Cerebral Artery Bifurcation Aneurysms
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 主要终点
- Complete occlusion rate of middle cerebral artery bifurcation aneurysms at 1-year follow-up (assessed according to the Raymond-Roy Classification)
研究概览
简要总结
The goal of this clinical trial is to learn if flow diverter (FD) offers advantages over conventional stent-assisted coiling in the treatment of middle cerebral artery (MCA) bifurcation aneurysms . It will also learn about the safety of flow diverter (FD) treatment. The main questions it aims to answer are:
Does flow diverter (FD) treatment improves the rate of complete aneurysm occlusion and patients' neurological function? Does flow diverter (FD) treatment loweres the probability of aneurysm recurrence and the occurrence of complications?
Researchers will compare FD to a conventional stent-assisted coiling to see if FD treatment works better to treat MCA bifurcation aneurysms.
Participants will:
Undergo stent-assisted coiling or flow diverter treatment Take pre-operative and pre-discharge head MRI scans, neurological function assessments, and cognitive function assessments Visit the clinic 1 year for checkups and tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unruptured wide-necked middle cerebral artery bifurcation aneurysms definitively diagnosed by CTA or DSA;
- •Aneurysms requiring stent-assisted embolization with the necessity of preserving branch arteries;
- •Indication for either flow diversion device or conventional stent-assisted coiling;
- •Age between 18 and 70 years, inclusive;
- •The subject or their legally authorized representative has signed the written informed consent form.
排除标准
- •Concomitant significant organ dysfunction (e.g., severe cardiac, hepatic, or renal insufficiency), chronic inflammatory disease, or malignancy;
- •Pregnant or lactating women;
- •Presence of significant neurological deficit (mRS score > 2);
- •Presence of contraindications to flow diversion device or stent-assisted coiling (e.g., severe allergy to metallic material, contraindication to antiplatelet medication);
- •Other conditions deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
Flow diverter treatment group
Flow diverter（FD, preferentially a Lattice stent) placement, with adjunctive minimal coiling of the aneurysm sac as needed.
干预措施: Flow diverter (Procedure)
Stent-assisted coiling treatment group
Underwent conventional stent-assisted coiling (preferentially using an LVIS stent)
干预措施: Stent-assisted coiling (Procedure)
结局指标
主要结局
Complete occlusion rate of middle cerebral artery bifurcation aneurysms at 1-year follow-up (assessed according to the Raymond-Roy Classification)
时间窗: 1 year
次要结局
- The rate of aneurysm recurrence at 1-year post-procedure(1 year)
- Patients' neurological outcomes at 6 months and 1 year post-procedure (mRS scores and Mini-mental state examination)(1 year)
- Patients' cognitive outcomes at 6 months and 1 year post-procedure (MMSE scores)(1 year)
- Incidence of Branch Vessel Patency and In-stent Stenosis Assessed by Digital Subtraction Angiography (DSA)(1 year)
- Total interventional procedure time (from puncture to completion of the procedure)(1 year)
研究者
庄宗
Deputy chief physician of Neurosurgery, Principal Investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School