Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Ma… (NCT05554471) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression
United States352 participantsStarted 2022-08-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days
Timeframe: 30 days post procedure
2
Primary Effectiveness Endpoint: Time to Ambulation
Timeframe: Post procedure
3
Primary Effectiveness Endpoint: Time to Hemostasis
. 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