NCT06740721尚未招募不适用
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Technical success
研究概览
简要总结
To determine the safety and feasibility of investigational product to reduce aortic dissection false lumen perfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age.
- •A candidate for false lumen (FL) embolization with a type B dissection, and no prior primary entry tear/TL treatment, OR
- •A candidate for FL embolization with a type B or type A dissection, in whom the primary entry tear/TL was treated in a previous procedure, and is now presenting with a FL requiring treatment.
排除标准
- •An inability to provide informed consent.
- •Enrolled in another clinical study other than a registry.
- •Hyperacute or acute aortic dissection (<15 days from symptom onset).
- •Untreated or uncovered primary entry/reentry tear proximal to left subclavian artery (before FL treatment with the investigational product).
- •Vascular disease, aortic rupture, and/or anatomy and/or dissection membrane condition that precludes the safe access and positioning of an introducer sheath and delivery (and expansion) of the investigational product into the FL.
- •Prior treatment of the FL.
- •Planned use of investigational devices to treat the primary entry tear and/or TL.
- •Absence of/inability to create a reentry tear/fenestration adequately positioned and large enough to allow introducer sheath access into the FL.
- •Planned use of FL embolic devices other than the investigational product.
- •Prior abdominal aortic aneurysm (AAA) treatment.
- •Planned concomitant major surgery (e.g., gastrointestinal surgery).
- •Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos syndrome).
- •Coagulopathy or uncontrolled bleeding disorder.
- •Serum creatinine level >2.5 mg/dL (within 90 days prior to the procedure).
- •Cerebrovascular accident within 90 days prior to the procedure.
- •Myocardial infarction and/or major heart surgery within 90 days prior to the procedure.
- •Atrial fibrillation that is not well rate controlled.
- •Unable or unwilling to comply with study follow-up requirements.
- •Life expectancy of <2 years postprocedure.
- •Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.
- •A condition that inhibits radiographic visualization during the study procedure and planned follow-up imaging.
- •History of allergy to contrast medium that cannot be managed medically.
- •Uncontrolled comorbid medical condition, including mental health issues, that, in the opinion of the investigator, would adversely affect participation in the study.
- •Participant is planning to become pregnant or is currently pregnant or lactating. For participants of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the study.
研究组 & 干预措施
Experimental: Intervention
Experimental
Device: False Lumen Embolization System Device: IMPEDE-FX RapidFill
干预措施: False Lumen Embolization System, IMPEDE-FX RapidFill (Device)
结局指标
主要结局
Technical success
时间窗: Immediately after the intervention
Delivery and implantation of the investigational product implant to the false lumen
Major adverse events
时间窗: 30 days
Incidence of device/procedure-related major adverse events
次要结局
- All-cause mortality and dissection-related mortality(2 years)
- Serious adverse events(2 years)
- Change in false lumen thrombosis from baseline(2 years)
- Change in true lumen/aorta size ratio from baseline(2 years)
- Change in aorta size from baseline(2 years)
- Rate of dissection-related reinterventions(2 years)
研究者
相似试验
招募中
不适用
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human StudyAortic DissectionNCT06550986Shape Memory Medical, Inc.30
Enrolling By Invitation
不适用
Aortic Compression Trial to Reduce Blood Loss at Cesarean SectionPost Partum HemorrhageCesarean Section ComplicationsAnemiaNCT05312658Karolinska Institutet2,246
撤回
不适用
POC for the Treatment of Subjects With Moderate AS Using Valvosoft® Non-Invasive Ultrasound TherapyNCT06650839Cardiawave SA10
已完成
不适用
Stent Trial for Coarctaion of the Aorta to evaluate the safety and efficacy of the Large Diameter Advanta V12 Covered Stent for treatment of native and recurrent coartation of the aorta with primary endpoint being a significant reduction in the gradient across the coarctation at 12 monthsPatients with a presence of native or recurrent coarctation of the aortaCardiovascular - Normal development and function of the cardiovascular systemACTRN12612000013864Atrium Medical Corporation70
招募中
1 期
Intervention of Acute Myocardial Infarction with integrated traditional Chinese Medicine and Western Medicine: a Randomized Controlled Trial.acute myocardial infarctionITMCTR2000003494Qilu Hospital of Shandong University