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

Not Applicable

Completed

• Conditions: Venous Vascular Closure
• Interventions: Device: MYNX CONTROL™ Venous Vascular Closure Device 6F-12F

• Registration Number: NCT05554471
• Lead Sponsor: Cordis Corporation

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2022-08-30
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-26
• Primary Completion: 2023-07-11
• Study Completion: 2023-07-11
• Results First Submitted: 2024-07-09
• Results First Submitted QC: 2024-08-02
• Results First Posted: 2024-08-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

1. Age >18
2. Able and willing to provide informed consent and to complete a follow-up visit at 30 days
3. 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

1. Any use of systemic steroids (IV or oral) within 30 days of procedure
2. History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis within 6 months of procedure
3. Presence of thrombocytopenia (platelet count < 100,000 cells/mm3) or anemia (hemoglobin < 10 g/dL, hematocrit < 30%)
4. History of bleeding disorders such hemophilia or von Willebrand's disease
5. Currently involved in any other investigational clinical trial
6. Documented history of uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg), or critical illness requiring intravenous vasopressors for blood pressure stabilization
7. Femoral arteriotomy or venotomy in either limb within 10 days pre procedure
8. Use of VCD in either limb within 30 days of procedure
9. Any planned procedure involving femoral arterial or venous access in either limb within 30 days or prior to study exit
10. Renal insufficiency (i.e., serum creatinine > 2.5 mg/dL)
11. Patients who are pregnant, planning to become pregnant during the study period, or lactating
12. Body-mass index (BMI) > 45 kg/m2 or <20 kg/m2
13. Unable to routinely walk at least 20 feet without assistance
14. Known allergy/adverse reaction to polyethylene glycol or contrast medium
15. 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
16. Previous vascular surgery or repair in the vicinity of the target access site within the previous 90 days of the procedure
17. Active systemic infection, or cutaneous infection or inflammation in the vicinity of the target access site
18. 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
19. Patients who refuse blood transfusion if it were to be needed
20. 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:

1. Any attempt at femoral arterial access or inadvertent arterial puncture with hematoma during the procedure
2. Any procedural complications that may interfere with routine recovery, ambulation, or discharge eligibility times
3. Physician deems that a different hemostasis approach for venous access sites is necessary
4. Physician deems that the subject should not attempt protocol required ambulation (reference ambulation protocol per section 14.2)
5. Venous access site location is noted to be above the inguinal ligament (cephalad to lower half of the femoral head or the inferior epigastric vein origin from the external iliac vein)
6. Intra-procedural bleeding around sheath, or suspected intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula
7. Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, accidental arterial stick with hematoma, "back wall stick", etc.)
8. A < 6F or > 12F procedural sheath is present at any time during the procedure or at closure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mynx Control Venous Closure	MYNX CONTROL™ Venous Vascular Closure Device 6F-12F	204 (2:1 randomized - 136 VCD:68 manual compression)
Manual Compression	MYNX CONTROL™ Venous Vascular Closure Device 6F-12F	204 (2:1 randomized - 136 VCD:68 manual compression)

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days	30 days post procedure	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.
Primary Effectiveness Endpoint: Time to Hemostasis	Post procedure	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).
Primary Effectiveness Endpoint: Time to Ambulation	Post procedure	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.

Secondary Outcome Measures

Name	Time	Method
Procedural Success	30 days post procedure	Defined as attainment of final hemostasis at all venous access sites without major venous access site closure-related complications through 30 days.
Time to Discharge Eligibility	Post Procedure	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.
Secondary Safety Endpoints: Minor Complications of the Target Limb Access Site Within 30 Days	30 days post procedure	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.
Device Success	During procedure	Defined as the ability to successfully deploy the MYNX CONTROL™ VENOUS VCD delivery system, deliver the polyethylene glycol hydrogel sealant, and achieve hemostasis.

Trial Locations

Locations (14)

NC Heart and Vascular Research; 🇺🇸 Raleigh, North Carolina, United States

Palm Vascular Centers; 🇺🇸 Miami Beach, Florida, United States

Arizona Cardiovascular Research Center; 🇺🇸 Phoenix, Arizona, United States

Baptist Health Miami Cardiac and Vascular Institute; 🇺🇸 Miami, Florida, United States

Colorado Heart and Vascular PC; 🇺🇸 Lakewood, Colorado, United States

Hightower Clinical; 🇺🇸 Oklahoma City, Oklahoma, United States

South Oklahoma Heart Research; 🇺🇸 Oklahoma City, Oklahoma, United States

Erlanger Health System; 🇺🇸 Chattanooga, Tennessee, United States

OnSite Clinical Solutions; 🇺🇸 Rock Hill, South Carolina, 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

Saint Luke's Hospital of Kansas City; 🇺🇸 Kansas City, Missouri, United States

Tampa Cardiovascular Interventions and Research; 🇺🇸 Tampa, Florida, United States