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

April 17, 2025 updated by: Cordis Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
352

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days
Time Frame: 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.
30 days post procedure
Primary Effectiveness Endpoint: Time to Ambulation
Time Frame: 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.
Post procedure
Primary Effectiveness Endpoint: Time to Hemostasis
Time Frame: 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).
Post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Safety Endpoints: Minor Complications of the Target Limb Access Site Within 30 Days
Time Frame: 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.
30 days post procedure
Time to Discharge Eligibility
Time Frame: 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.
Post Procedure
Procedural Success
Time Frame: 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.
30 days post procedure
Device Success
Time Frame: 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.
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cordis Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NAMSA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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