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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
352
Mynx Control Venous VCD 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis and ambulation.
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
Colorado Heart and Vascular PC
Lakewood, Colorado, United States
Baptist Health Miami Cardiac and Vascular Institute
Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days
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.
Time frame: 30 days post procedure
Primary Effectiveness Endpoint: Time to Ambulation
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.
Time frame: Post procedure
Primary Effectiveness Endpoint: Time to Hemostasis
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).
Time frame: Post procedure
Secondary Safety Endpoints: Minor Complications of the Target Limb Access Site Within 30 Days
Defined as the rate of CEC adjudicated combined minor venous access site closure-related complications through 30 days post-procedure, attributed directly to MYNX CONTROL™ Venous VCD or Manual Compression without other likely cause.
Time frame: 30 days post procedure
Time to Discharge Eligibility
Defined as elapsed time (in hours) between removal of the final MYNX CONTROL™ Venous VCD or removal of the final sheath and when subject is eligible for discharge from the institution based on the assessment of the attending physician.
Time frame: Post Procedure
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Miami, Florida, United States
Palm Vascular Centers
Miami Beach, Florida, United States
Tampa Cardiovascular Interventions and Research
Tampa, Florida, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States
OnSite Clinical Solutions
Rock Hill, South Carolina, United States
...and 4 more locations
Procedural Success
Defined as attainment of final hemostasis at all venous access sites without major venous access site closure-related complications through 30 days.
Time frame: 30 days post procedure
Device Success
Defined as the ability to successfully deploy the MYNX CONTROL™ VENOUS VCD delivery system, deliver the polyethylene glycol hydrogel sealant, and achieve hemostasis.
Time frame: During procedure