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

A Multicenter, Prospective, Randomized, Controlled, Open Label Trial to Evaluate the Safety and Efficacy of Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression in Patients Who Have Undergone Endovascular Procedures Utilizing up to 12F Procedural Sheaths

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.

Study Overview

• Status: Completed
• Conditions: Venous Vascular Closure
• Intervention / Treatment: Device: MYNX CONTROL™ Venous Vascular Closure Device 6F-12F

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 Type: Interventional
• Enrollment (Actual): 352
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Cardiovascular Research Center
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Heart and Vascular PC
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Health Miami Cardiac and Vascular Institute
    • Miami Beach, Florida, United States, 33312
      • Palm Vascular Centers
    • Tampa, Florida, United States, 33614
      • Tampa Cardiovascular Interventions and Research
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • NC Heart and Vascular Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
      • South Oklahoma Heart Research
    • Oklahoma City, Oklahoma, United States, 73134
      • Hightower Clinical
  • South Carolina
    • Rock Hill, South Carolina, United States, 28277
      • Onsite Clinical Solutions
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health System
  • Texas
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital
    • McAllen, Texas, United States, 78503
      • Rio Grande Regional Hospital
    • McKinney, Texas, United States, 75069
      • North Dallas Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mynx Control Venous Closure; 204 (2:1 randomized - 136 VCD:68 manual compression)	Device: MYNX CONTROL™ Venous Vascular Closure Device 6F-12F; Mynx Control Venous VCD 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis and ambulation.
Active Comparator: Manual Compression; 204 (2:1 randomized - 136 VCD:68 manual compression)	Device: MYNX CONTROL™ Venous Vascular Closure Device 6F-12F; Mynx Control Venous VCD 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis and ambulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	Post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Post Procedure
Procedural Success	Defined as attainment of final hemostasis at all venous access sites without major venous access site closure-related complications through 30 days.	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.	During procedure

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Collaborators: NAMSA

Publications and helpful links

General Publications

• Summers J, Swarup V, Parker I, Bumgarner J, Brenyo A, Saleh L, Sadanandan, Sanchez J, Beasley R, Gupta S; other members of the ReliaSeal Study Group. Safety and Efficacy of a Novel Sealant-Based Vascular Closure Device Following Electrophysiology Procedures: ReliaSeal Trial. J Cardiovasc Electrophysiol. 2025 Mar 17. doi: 10.1111/jce.16623. Online ahead of print.

Helpful Links

• Original Article, First published: 17 March 2025

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): July 11, 2023
• Study Completion (Actual): July 11, 2023

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: manual compression
• Other Study ID Numbers: P22-8301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No