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

NCT ID: NCT05554471

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-30
• Study Completion Date: 2023-07-11

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.

Conditions

Venous Vascular Closure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mynx Control Venous Closure

204 (2:1 randomized - 136 VCD:68 manual compression)

Group Type: EXPERIMENTAL

MYNX CONTROL™ Venous Vascular Closure Device 6F-12F

Intervention Type: DEVICE

Mynx Control Venous VCD 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis and ambulation.

Manual Compression

204 (2:1 randomized - 136 VCD:68 manual compression)

Group Type: ACTIVE_COMPARATOR

MYNX CONTROL™ Venous Vascular Closure Device 6F-12F

Intervention Type: DEVICE

Mynx Control Venous VCD 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis and ambulation.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NAMSA

OTHER

Sponsor Role: collaborator

Cordis Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

References

Summers J, Swarup V, Parker I, Bumgarner J, Brenyo A, Saleh L, Sadanandan S, 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 May;36(5):1022-1031. doi: 10.1111/jce.16623. Epub 2025 Mar 17.

Reference Type: RESULT

PMID: 40098328 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

P22-8301

Identifier Type: -

Identifier Source: org_study_id