Clinical trial NCT05554471: Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Vascular Closure
Keywords: manual compression
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2022-09-26
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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

Primary outcomes:
measure: Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days
timeFrame: 30 days post procedure
measure: Primary Effectiveness Endpoint: Time to Ambulation
timeFrame: Post procedure
measure: Primary Effectiveness Endpoint: Time to Hemostasis
timeFrame: Post procedure
Secondary outcomes:
measure: Secondary Safety Endpoints: Minor Complications of the Target Limb Access Site Within 30 Days
timeFrame: 30 days post procedure
measure: Time to Discharge Eligibility
timeFrame: Post Procedure
measure: Procedural Success
timeFrame: 30 days post procedure
measure: Device Success
timeFrame: During procedure
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Cardiovascular Research Center
state: Arizona
city: Lakewood
country: United States
facility: Colorado Heart and Vascular PC
state: Colorado
city: Miami Beach
country: United States
facility: Palm Vascular Centers
state: Florida
city: Miami
country: United States
facility: Baptist Health Miami Cardiac and Vascular Institute
state: Florida
city: Tampa
country: United States
facility: Tampa Cardiovascular Interventions and Research
state: Florida
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research
state: Oklahoma
city: Rock Hill
country: United States
facility: OnSite Clinical Solutions
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: McAllen
country: United States
facility: Rio Grande Regional Hospital
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associates
state: Texas
Study officials:
References:
citation: 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.