N/A
N=270
Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression
Venous Vascular Closure
Bottom Line
View on ClinicalTrials.gov: NCT05554471 ↗Enrolled (actual)
270
Serious AEs
5.2%
Results posted
Aug 2024
Primary outcome: Primary: Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days — 0; 1 limbs
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MYNX CONTROL™ Venous Vascular Closure Device 6F-12F (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cordis US Corp.
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days |
0; 1 | — |
| PRIMARY Primary Effectiveness Endpoint: Time to Ambulation |
2.6; 5.1 | <0.001 sig |
| PRIMARY Primary Effectiveness Endpoint: Time to Hemostasis |
2.1; 11.4 | <0.001 sig |
| SECONDARY Secondary Safety Endpoints: Minor Complications of the Target Limb Access Site Within 30 Days |
0; 6 | — |
| SECONDARY Time to Discharge Eligibility |
3.1; 5.5 | <0.001 sig |
| SECONDARY Procedural Success |
171; 89 | — |
| SECONDARY Device Success |
470 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 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 12F procedural sheath is present at any time during the procedure or at closure
Data sourced from ClinicalTrials.gov (NCT05554471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.