Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression
NCT05554471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 352
Last updated 2025-04-24
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.
Conditions
- Venous Vascular Closure
Interventions
- 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.
Sponsors & Collaborators
-
NAMSA
collaborator OTHER -
Cordis Corporation
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-30
- Primary Completion
- 2023-07-11
- Completion
- 2023-07-11
- FDA Device
- Yes
Countries
- United States
Study Locations
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