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Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression
NA trial testing MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in Venous Vascular Closure in 352 participants. Completed in 11 July 2023.
| Lead sponsor | Cordis US Corp. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 352 |
| Start date | 30 August 2022 |
| Primary completion | 11 July 2023 |
| Estimated completion | 11 July 2023 |
| Sites | 14 locations across United States |
Cordis US Corp. — full company profile →
18 and older, any sex, with Venous Vascular Closure. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| MYNX CONTROL™ VENOUS VCD | 0 | |
| Manual Compression | 1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| MYNX CONTROL™ VENOUS VCD | 2.6 | ± 1.03 |
| Manual Compression | 5.1 | ± 4.35 |
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).
| Group | Value | 95% CI |
|---|---|---|
| MYNX CONTROL™ VENOUS VCD | 2.1 | ± 1.79 |
| Manual Compression | 11.4 | ± 7.19 |
Defined as the rate of CEC adjudicated combined minor venous access site closure-related complications through 30 days post-procedure, attributed directly to MYNX CONTROL™ Venous VCD or Manual Compression without other likely cause.
| Group | Value | 95% CI |
|---|---|---|
| MYNX CONTROL™ VENOUS VCD | 0 | |
| Manual Compression | 6 |
Defined as elapsed time (in hours) between removal of the final MYNX CONTROL™ Venous VCD or removal of the final sheath and when subject is eligible for discharge from the institution based on the assessment of the attending physician.
| Group | Value | 95% CI |
|---|---|---|
| MYNX CONTROL™ VENOUS VCD | 3.1 | ± 1.24 |
| Manual Compression | 5.5 | ± 4.58 |
Defined as attainment of final hemostasis at all venous access sites without major venous access site closure-related complications through 30 days.
| Group | Value | 95% CI |
|---|---|---|
| MYNX CONTROL™ VENOUS VCD | 171 | |
| Manual Compression | 89 |
Defined as the ability to successfully deploy the MYNX CONTROL™ VENOUS VCD delivery system, deliver the polyethylene glycol hydrogel sealant, and achieve hemostasis.
| Group | Value | 95% CI |
|---|---|---|
| MYNX CONTROL™ VENOUS VCD | 470 |
Time frame: 30 days follow-up. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | MYNX CONTROL™ VENOUS VCD | Manual Compression |
|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — |
| Pericardial effusion | Cardiac disorders | — | — |
| Sinus bradycardia | Cardiac disorders | — | — |
| Haematochezia | Gastrointestinal disorders | — | — |
| Chest pain | General disorders | — | — |
| Systemic inflammatory response syndrome | General disorders | — | — |
| Rhinovirus infection | Infections and infestations | — | — |
| Psychogenic seizure | Nervous system disorders | — | — |
| Haematuria | Renal and urinary disorders | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Arterial haemorrhage | Vascular disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Vascular compression | Vascular disorders | — | — |
| Reaction | System | MYNX CONTROL™ VENOUS VCD | Manual Compression |
|---|---|---|---|
| Procedural nausea | Injury, poisoning and procedural complications | — | — |
| Haematoma | Vascular disorders | — | — |
Most-reported serious reactions: Cerebrovascular accident, Cardiac failure congestive, Pericardial effusion, Sinus bradycardia, Haematochezia, Chest pain, Systemic inflammatory response syndrome, Rhinovirus infection.
Data from ClinicalTrials.gov NCT05554471 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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