AzTrials
AzTrials

Venous Vascular ClosureReliaSealNCT05554471

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

A study of Venous Vascular Closure, run by Cordis US Corp. at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Vascular Closure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
14 sitesUnited States
Study dates
30 Aug 2022to 11 Jul 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • Femoral arteriotomy or venotomy in either limb within 10 days pre procedure
  • Use of VCD in either limb within 30 days of procedure
  • Any planned procedure involving femoral arterial or venous access in either limb within 30 days or prior to study exit
  • Renal insufficiency (i.e., serum creatinine > 2.5 mg/dL)
  • Patients who are pregnant, planning to become pregnant during the study period, or lactating
  • Body-mass index (BMI) > 45 kg/m2 or <20 kg/m2
  • Unable to routinely walk at least 20 feet without assistance
  • Known allergy/adverse reaction to polyethylene glycol or contrast medium
  • 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
  • Previous vascular surgery or repair in the vicinity of the target access site within the previous 90 days of the procedure
  • Active systemic infection, or cutaneous infection or inflammation in the vicinity of the target access site
  • 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
  • Patients who refuse blood transfusion if it were to be needed
  • 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:
  • Any attempt at femoral arterial access or inadvertent arterial puncture with hematoma during the procedure
  • Any procedural complications that may interfere with routine recovery, ambulation, or discharge eligibility times
  • Physician deems that a different hemostasis approach for venous access sites is necessary
  • Physician deems that the subject should not attempt protocol required ambulation (reference ambulation protocol per section 14.2)
  • 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)
  • Intra-procedural bleeding around sheath, or suspected intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula
  • 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.)
  • A < 6F or > 12F procedural sheath is present at any time during the procedure or at closure

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Erlanger Health System

    Chattanooga, Tennessee, 37403

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Colorado Heart and Vascular PC

    Lakewood, Colorado, 80228

  • Rio Grande Regional Hospital

    McAllen, Texas, 78503

  • North Dallas Research Associates

    McKinney, Texas, 75069

  • Baptist Health Miami Cardiac and Vascular Institute

    Miami, Florida, 33176

  • Palm Vascular Centers

    Miami Beach, Florida, 33312

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73134

  • South Oklahoma Heart Research

    Oklahoma City, Oklahoma, 73135

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27607

  • OnSite Clinical Solutions

    Rock Hill, South Carolina, 28277

  • Tampa Cardiovascular Interventions and Research

    Tampa, Florida, 33614

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
MYNX CONTROL™ Venous Vascular Closure Device 6F-12F
Keywords
manual compression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT05554471
Study groupRoleWhat they receive
Mynx Control Venous ClosureExperimental204 (2:1 randomized - 136 VCD:68 manual compression)
Receives: Device: MYNX CONTROL™ Venous Vascular Closure Device 6F-12F
Manual CompressionActive comparator204 (2:1 randomized - 136 VCD:68 manual compression)
Receives: Device: MYNX CONTROL™ Venous Vascular Closure Device 6F-12F

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days post procedure

  2. 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.

    Measured: Post procedure

  3. 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).

    Measured: Post procedure

Secondary outcomes (4)

  1. 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.

    Measured: 30 days post procedure

  2. 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.

    Measured: Post Procedure

  3. Procedural Success

    Defined as attainment of final hemostasis at all venous access sites without major venous access site closure-related complications through 30 days.

    Measured: 30 days post procedure

  4. 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.

    Measured: During procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2022
  2. Study start30 Aug 2022
  3. Primary completion11 Jul 2023
  4. Study completion11 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05554471
Sponsor's protocol ID
P22-8301
Acronym
ReliaSeal
Status last verified
Apr 2025
First submitted
20 Sep 2022
Last updated
24 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 40098328

Questions about this trial

What is this clinical trial studying?

A study of Venous Vascular Closure, run by Cordis US Corp. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days (time frame: 30 days post procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05554471, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in