Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Venous Vascular Closure

Intervention / Treatment
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* Device: MYNX CONTROL™ Venous Vascular Closure Device 6F-12F


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 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 Exclusion Criteria: History of chronic use of high dose systemic steroids or history of any immunodeficiency History of coagulation disorders such as deep vein thrombosis, pulmonary embolism, or thrombophlebitis History of bleeding disorders such as thrombocytopenia (platelet count < 100,000 cells/mm3), hemophilia, von Willebrand's disease or anemia (hemoglobin < 10 g/dL, hematocrit < 30%) 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) 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 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 Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30% Patients with expected life of less than 30 days Any attempt at femoral arterial access or inadvertent arterial puncture with hematoma during the procedure Venous access site location is noted to be high, 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 < 5F or > 12F procedural sheath is present at any time during the procedure or at closure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mynx Control Venous Closure<br>204 (2:1 randomized - 136 VCD:68 manual compression) | Device: MYNX CONTROL™ Venous Vascular Closure Device 6F-12F<br>* Mynx Control Venous VCD 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis and ambulation.<br>|
| Active Comparator: Manual Compression<br>204 (2:1 randomized - 136 VCD:68 manual compression) | Device: MYNX CONTROL™ Venous Vascular Closure Device 6F-12F<br>* Mynx Control Venous VCD 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis and ambulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint: Major Venous Access Site Closure-related Complications | Rate of combined major venous access site closure-related complications attributed directly to VCD or manual compression without other likely cause | 30 days post procedure | 
| Primary Effectiveness Endpoint: Time to Ambulation | Elapsed time between removal of the MYNX CONTROL Venous VCD 6F-12F device (treatment arm) or of the final sheath (control arm) and when subject stands and walks 20 feet without evidence of rebleeding from any femoral venous access site. | Post procedure, usually within 6 hours | 
| Primary Effectiveness Endpoint: Time to Hemostasis | Elapsed time between removal of the MYNX CONTROL Venous VCD 6F-12F device (treatment arm) or of the final sheath (control arm) and first observed and confirmed venous hemostasis (per access site analysis) | Post procedure, usually within 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manual compression