Venous Vascular Closure Clinical Trial
Official title:
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
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.
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. ;