NCT03171155已完成不适用
Prospective, Multi-Center, Single Arm Study of the Medeon Biodesign XPro™ Suture-Mediated Vascular Closure Device System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 11
- 主要终点
- Time to Hemostasis
研究概览
简要总结
To access the safety and performance of the XPro System to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the common femoral.
详细描述
This is a prospective multi-center, single arm study to assess the safety and performance of the XPro System compared to a historical control developed from published studies of two marketed competitive devices, Perclose ProGlide® and Prostar® XL (both from Abbott Vascular, Inc., Redwood City, CA, USA). The goal of the study is to show that XPro System is non-inferior to the competitors in efficacy and safety. Patients scheduled for percutaneous BAV, TAVR/TAVI, EVAR, or TEVAR procedures using an 8-18 Fr introducer sheath will be screened for study eligibility. Patients will be followed for 30 days post procedure.
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
- •Patient is > 18 years old
- •Patient is scheduled for percutaneous BAV, TAVR/TAVI, EVAR, or TEVAR involving access through the femoral artery using an 8-18 Fr introducer sheath
- •Patient is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
- •Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
- •Patient is willing and able to complete follow-up
排除标准
- •Prior intra-aortic balloon pump at access site
- •Patients with severe claudication, iliac or femoral artery diameter stenosis greater than 50%
- •Common femoral artery lumen diameter is < 6 mm
- •Prior target artery closure with any closure device < 90 days, or closure with manual compression ≤ 30 days prior to index procedure
- •Prior vascular surgery, vascular graft, or stent in region of access site
- •Patients receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure
- •Patients with significant anemia ((Hgb < 10 g/dL, Hct < 30%)
- •Patient with known bleeding disorder including thrombocytopenia (platelet count < 100,000), thrombasthenia, hemophilia or Von Willebrand's disease
- •Patients with renal insufficiency (serum creatinine level > 221µmol/L) or renal transplant
- •Known allergy to contrast reagent
- •Inability to tolerate aspirin and/or other anticoagulation treatment
- •Planned anticoagulation therapy post-procedure such that ACT is expected to be elevated above 350 seconds for more than 24 hours after the procedure
- •Connective tissue disease (e.g., Marfan's Syndrome)
- •Thrombolytics (e.g. t-PA, streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the procedure
- •Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction
- •Patients who are morbidly obese BMI > 40 kg/m2
- •Planned major intervention or surgery within 30 days following the interventional procedure
- •Patients who are unable to ambulate at baseline
- •Currently participating in a clinical study of an investigational device or drug that has not completed study endpoint
- •Known allergy to any device component
- •Patient is known or suspected to be pregnant or lactating
- •Life expectancy < 1 year as judged by the investigator
- •Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating Intra-Procedure
- •Access site above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
- •Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
- •Ipsilateral femoral venous sheath during the catheterization procedure
- •Common femoral artery calcium, which is fluoroscopically visible
- •Patients where there is difficulty inserting the introducer sheath or greater than 2 ipsilateral arterial punctures at the start of the catheterization procedure
- •Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
- •Evidence of a pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site
- •Patients with intra-procedural bleeding around access site
- •Evidence of active systemic or local groin infection
- •Patients receiving glycoprotein IIb/IIIa inhibitors during, or after the catheterization procedure
研究组 & 干预措施
XPro System
Experimental
Implantation of XPro System during percutaneous vascular closure
干预措施: XPro System (Device)
结局指标
主要结局
Time to Hemostasis
时间窗: 15 minutes
Time to hemostasis absent of any access-site-related adjunctive surgical or endovascular procedures.
Freedom from major VARC-2 events
时间窗: Up to 30 days of procedure
Freedom from major VARC-2 events within 30 days of the procedure.
次要结局
- Freedom from minor VARC-2 events(Up to 30 days of procedure)
- Successful hemostasis with the XPro System(at 48 hours or at discharge from hospital, whichever comes first; and up to 30 days post-procedure)
- Freedom from access-site infection(Up to 30 days of procedure)
研究者
研究点 (11)
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