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

Cordis

Status: Completed

Conditions: Venous Vascular Closure

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05554471

P22-8301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 352 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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352 participants in 2 patient groups

Mynx Control Venous Closure

Experimental group

Description:

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

Treatment:

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

Manual Compression

Active Comparator group

Description:

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

Treatment:

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