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
1 other identifier
interventional
352
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 30, 2022
CompletedFirst Submitted
Initial submission to the registry
September 20, 2022
CompletedFirst Posted
Study publicly available on registry
September 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2023
CompletedResults Posted
Study results publicly available
August 6, 2024
CompletedApril 24, 2025
April 1, 2025
11 months
September 20, 2022
July 9, 2024
April 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Secondary Safety Endpoints: Minor Complications of the Target Limb Access Site Within 30 Days
30 days post procedure
Time to Discharge Eligibility
Post Procedure
Procedural Success
30 days post procedure
Device Success
During procedure
Study Arms (2)
Mynx Control Venous Closure
EXPERIMENTAL204 (2:1 randomized - 136 VCD:68 manual compression)
Manual Compression
ACTIVE COMPARATOR204 (2:1 randomized - 136 VCD:68 manual compression)
Interventions
Mynx Control Venous VCD 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis and ambulation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cordis US Corp.lead
- NAMSAcollaborator
Study Sites (14)
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016, United States
Colorado Heart and Vascular PC
Lakewood, Colorado, 80228, United States
Baptist Health Miami Cardiac and Vascular Institute
Miami, Florida, 33176, United States
Palm Vascular Centers
Miami Beach, Florida, 33312, United States
Tampa Cardiovascular Interventions and Research
Tampa, Florida, 33614, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
NC Heart and Vascular Research
Raleigh, North Carolina, 27607, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73134, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135, United States
OnSite Clinical Solutions
Rock Hill, South Carolina, 28277, United States
Erlanger Health System
Chattanooga, Tennessee, 37403, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Rio Grande Regional Hospital
McAllen, Texas, 78503, United States
North Dallas Research Associates
McKinney, Texas, 75069, United States
Related Publications (1)
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.
PMID: 40098328RESULT
Related Links
Results Point of Contact
- Title
- Jenny Jimenez
- Organization
- Cordis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2022
First Posted
September 26, 2022
Study Start
August 30, 2022
Primary Completion
July 11, 2023
Study Completion
July 11, 2023
Last Updated
April 24, 2025
Results First Posted
August 6, 2024
Record last verified: 2025-04