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 range18 Years

SexALL

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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
✕. 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

What they're measuring

Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days

Timeframe: 30 days post procedure

Primary Effectiveness Endpoint: Time to Ambulation

Timeframe: Post procedure

Primary Effectiveness Endpoint: Time to Hemostasis

Timeframe: Post procedure

Trial details

NCT IDNCT05554471

SponsorCordis US Corp.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-11

Results submitted2024-07-09

View on ClinicalTrials.gov More Venous Vascular Closure trials