NL-OMON42594已完成不适用
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device - MANTA PSD-051
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Candidate for non-emergent transcatheter interventional procedure via a 10-18F femoral sheath (e.g., transcatheter aortic valve replacement [TAVR], balloon aortic valvuloplasty [BAV], abdominal aortic aneurysm [AAA] stent-graft placement)
- •* Eligible for sheath removal in the catheterization lab
- •* Age *18 years
- •* Understand and sign the study specific written informed consent form
- •* Able and willing to fulfill the follow-up requirements
- •* In the Investigator*s opinion, the patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial
- •* Patients of childbearing age with Negative Pregnancy Test within 7 days of procedure
排除标准
- •Baseline exclusions:
- •* Patients who are known to be pregnant or lactating
- •* Patients who are immunocompromised or with pre-existing autoimmune disease
- •* Patients who have a systemic infection or a local infection at or near the access site
- •* Patients requiring a re-puncture at a site previously punctured within 48 hours
- •* Patients with significant anemia (hemoglobin <6.5 mmol/L, Hematocrit<30 )
- •* Patients who are morbidly obese or cachectic (BMI >40 or <20)
- •* Patients with Systolic Blood Pressure >180 mmHg, unless Systolic Pressure can be lowered by pharmacological agents prior to closure
- •* Patients who are currently participating in another clinical trial of an investigational device or drug that has not concluded the follow-up period
- •* Patients in whom an antegrade puncture is performed or planned
- •* Patients with a known bleeding disorder including thrombocytopenia (platelet count <100 x 10^9/L), thrombasthenia, hemophilia, or von Willebrand*s disease
- •* Patients with a femoral artery <6 mm in diameter, femoral artery stenosis resulting in a vessel diameter <6 mm, or patients with severe peripheral vascular disease
- •* Common femoral artery with fluoroscopically visible calcium, as determined by Angio CT, precluding safe access in the opinion of the investigator.
- •* Patients with allergy to bovine materials, collagen and/or collagen products, or polyglycolic or polyactic acid polymers
- •* Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence or life threatening disease
- •* Patients punctured through a vascular graft
- •* Patients with known allergy to stainless steel or nickel
- •* Patients who have acute ST-elevation MI within 48 hours prior to the procedure
- •* Patients with unilateral or bilateral lower extremity amputation
- •* Patients with renal insufficiency (serum creatinine > 2,5mg/dl)
- •* Patients undergoing therapeutic thrombolysis
- •* Patients who are unable to ambulate at baseline (necessary to determine time-to-ambulation)
- •* Patients undergoing an interventional procedure whom are being treated with warfarin
- •* Patients requiring a continuous oral anticoagulation therapy or patients with INR >1.8. Patients may be admitted into the study if oral anticoagulation therapy is stopped prior to procedure and resumed after the procedure.;Intra-procedure exclusions:
- •* Patients with puncture sites believed to be in the profunda femoris, superficial femoral artery, or at the bifurcation of the arteries
- •* Femoral arteries that are suspected to have experienced a back wall puncture or that underwent > one (1) arterial puncture during the catheterization procedure
- •* Patients in whom the puncture site is located above the most inferior border of the epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma/bleed
- •* Patients in whom bacterial contamination of the procedure sheath or surrounding tissues may have occurred as this may result in infection
- •* Patients having a complication(s) at the femoral artery access site pre-sheath removal including hematoma, pseudoaneurysm, or arterio-venous fistula
- •* Patients whose ACT is >250 seconds prior to removal of the guiding catheter
- •* Patients with marked turtuosity of the femoral or iliac artery
研究者
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