A Multicenter, Prospective, Randomized, Controlled, Open Label Trial to Evaluate the Safety and Efficacy of Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression in Patients Who Have Undergone Endovascular Procedures Utilizing up to 12F Procedural Sheaths
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 28
- 主要终点
- Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days
研究概览
简要总结
ReliaSeal is a clinical trial designed to evaluate safety and efficacy of use of MYNX CONTROL™ Venous Vascular Closure Device 6F-12F vs. manual compression to seal femoral access sites in patients who have undergone endovascular procedures utilizing up to 12F procedural sheaths in one or both limbs.
详细描述
ReliaSeal is a multicenter, prospective, randomized, controlled, open label clinical trial designed to evaluate safety and efficacy of use of MYNX CONTROL™ Venous Vascular Closure Device 6F-12F vs. manual compression to seal femoral access sites in patients who have undergone endovascular procedures utilizing up to 12F procedural sheaths in one or both limbs. The study is planned to enroll 204 patients with an additional group of patients to be part of the initial roll-in phase. Up to two (2) roll-in patients per physician will be allowed. All patients who sign the informed consent and randomized to either treatment arm will be followed through 30 days post procedure. There will be up to 15 participating study sites, with a minimum of five (5) sites, all located in the United States.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide informed consent and to complete a follow-up visit at 30 days
- •Planned catheter-based procedures via the common femoral vein(s) using up 6F to 12F introducer sheaths which meet indications for elective, nonemergent interventions of disease state, without contraindications for emergent vascular surgery or manual compression of the venous access sites
排除标准
- •Any use of systemic steroids (IV or oral) within 30 days of procedure
- •History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis within 6 months of procedure
- •Presence of thrombocytopenia (platelet count < 100,000 cells/mm3) or anemia (hemoglobin < 10 g/dL, hematocrit < 30%)
- •History of bleeding disorders such hemophilia or von Willebrand's disease
- •Currently involved in any other investigational clinical trial
- •Documented history of uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg), or critical illness requiring intravenous vasopressors for blood pressure stabilization
- •Femoral arteriotomy or venotomy in either limb within 10 days pre procedure
- •Use of VCD in either limb within 30 days of procedure
- •Any planned procedure involving femoral arterial or venous access in either limb within 30 days or prior to study exit
- •Renal insufficiency (i.e., serum creatinine > 2.5 mg/dL)
- •Patients who are pregnant, planning to become pregnant during the study period, or lactating
- •Body-mass index (BMI) > 45 kg/m2 or <20 kg/m2
- •Unable to routinely walk at least 20 feet without assistance
- •Known allergy/adverse reaction to polyethylene glycol or contrast medium
- •Planned procedures (including staged) or concomitant conditions/comorbidities that per investigator's judgment may extend ambulation attempts beyond 2-3 hours, and/or require extended hospitalization or re-hospitalization
- •Previous vascular surgery or repair in the vicinity of the target access site within the previous 90 days of the procedure
- •Active systemic infection, or cutaneous infection or inflammation in the vicinity of the target access site
- •Current COVID-19 infection (with or without symptoms), positive test for COVID- 19 within 14 days, or recent exposure to a person with COVID-19 infection
- •Patients who refuse blood transfusion if it were to be needed
- •Patients with expected life of less than 30 days
- •Intra-Procedural Exclusion Criteria
- •Patients who meet any of the following criteria during the index procedure will be excluded:
- •Any attempt at femoral arterial access or inadvertent arterial puncture with hematoma during the procedure
- •Any procedural complications that may interfere with routine recovery, ambulation, or discharge eligibility times
- •Physician deems that a different hemostasis approach for venous access sites is necessary
- •Physician deems that the subject should not attempt protocol required ambulation (reference ambulation protocol per section 14.2)
- •Venous access site location is noted to be above the inguinal ligament (cephalad to lower half of the femoral head or the inferior epigastric vein origin from the external iliac vein)
- •Intra-procedural bleeding around sheath, or suspected intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula
- •Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, accidental arterial stick with hematoma, "back wall stick", etc.)
- •A < 6F or > 12F procedural sheath is present at any time during the procedure or at closure
结局指标
主要结局
Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days
时间窗: 30 days post procedure
Defined as the rate of CEC adjudicated combined major venous access site closure-related complications through 30 days post-procedure, attributed directly to VCD or Manual Compression without other likely cause.
Primary Effectiveness Endpoint: Time to Hemostasis
时间窗: Post procedure
Defined as time (in minutes) between removal of each MYNX CONTROL™ Venous Vascular Closure Device 6F-12F device (device group) or of each sheath (control group) and first observed and confirmed venous hemostasis (per access site analysis).
Primary Effectiveness Endpoint: Time to Ambulation
时间窗: Post procedure
Defined as time (in hours) between removal of the MYNX CONTROL™ Venous Vascular Closure Device 6F-12F device (device group) or of the final sheath (control group) and when subject stands and walks 20 feet without evidence of rebleeding from any femoral venous access site.
次要结局
- Procedural Success(30 days post procedure)
- Time to Discharge Eligibility(Post Procedure)
- Secondary Safety Endpoints: Minor Complications of the Target Limb Access Site Within 30 Days(30 days post procedure)
- Device Success(During procedure)