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

Completed · Not applicable

Conditions studied: Venous Vascular Closure

In brief

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.

Key facts

Study ID

NCT05554471

Run by

Cordis US Corp.

People needed

352

Starts

2022-08-30

Expected to finish

2023-07-11

Last updated by the study team

2025-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18
• 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

You may not qualify if…

• 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

Where it is running

• Arizona Cardiovascular Research Center — Phoenix, Arizona, United States
• Colorado Heart and Vascular PC — Lakewood, Colorado, United States
• Baptist Health Miami Cardiac and Vascular Institute — 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
• Erlanger Health System — Chattanooga, Tennessee, United States
• Medical City Dallas Hospital — Dallas, Texas, United States
• Rio Grande Regional Hospital — McAllen, Texas, United States
• North Dallas Research Associates — McKinney, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.