JPRN-UMIN000014537已完成未知
A prospective, multi-center, single-arm study of SJN1301 to treat large or giant wide neck aneurysm - A prospective, multi-center, single-arm study of SJN1301 to treat large or giant wide neck aneurysm
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.Known allergy or contraindication to aspirin, clopidogrel/Plavix, heparin, local or general anesthesia 2.Known history of life threatening allergy to contrast dye 3.Known allergy to nickel, chromium cobalt, tungsten or platinum. 4.Subject has documented resistance to clopidogrel/Plavix. 5.Major surgery within previous 30 days or planned in the study follow up 6.Previous intracranial implant within the past 12 weeks prior to treatment date 7.Contraindication to CT scan or MRI 8.Severe neurological deficit that renders the subject incapable of living independently 9.Unstable neurological deficit (i.e worsening of clinical condition in the last 30 days) 10.Evidence of active infection at the time of treatment 11.Dementia or psychiatric problem that prevents the subject from completing required follow up 12.Limit survival to less than 24 months 13.Serum creatinine >=2.5 mg/dL 14.Female subjects who are pregnant or planning to become pregnant within the study period and who are unwilling to take adequate method of contraception for at least until the study follow up 15.Subject with an intracranial mass (tumor, except meningioma, abscess, or other infection), or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region 16.Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date 17.Subject has a non-treated arterio-venous malformation (AVM) in the territory of the target aneurysm 18.Enrollment in another trial involving an investigational product 19.Subject has a need for long-term use of anticoagulants 20.The patient who are inappropriate for participating in the study in the judgment of the principal investigator or sub-investigator
研究者
相似试验
招募中
Unknown
PASSAGE Clinical TrialJPRN-jRCT2032220496Kawahara Kazuo51
进行中（未招募）
1 期
ivolumab after selective internal radiation therapy using SIR-Spheres to treat patients with primary liver cancer: a safety and efficacy studyHepatocellular carcinomaEUCTR2017-000232-34-ESClínica Universidad de Navarra/Universidad de Navarra42
尚未招募
4 期
A study of Romiplostim Powder for Injection in patientsCTRI/2021/08/035609Intas Pharmaceuticals Limited
已完成
Unknown
OFT-G1-301 StudyCongenital heart diseaseJPRN-jRCT1080224691TEIJIN LIMITED / TEIJIN PHARMA LIMITED30
已完成
不适用
Prospective Multi-Center, Single Arm Study of the Shockwave Coronary Rx Lithoplasty® System in Coronary Arteriesarterial stenosisstenotic coronary arteries10011082NL-OMON43455Shockwave Medical Inc.15