Venous Vascular Closure
Conditions
Keywords
manual compression
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.
Interventions
DEVICEMYNX 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
NAMSA
Cordis US Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days | 30 days post procedure | 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. |
| Primary Effectiveness Endpoint: Time to Ambulation | Post procedure | 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. |
| Primary Effectiveness Endpoint: Time to Hemostasis | Post procedure | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Endpoints: Minor Complications of the Target Limb Access Site Within 30 Days | 30 days post procedure | 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. |
| Device Success | During procedure | Defined as the ability to successfully deploy the MYNX CONTROL™ VENOUS VCD delivery system, deliver the polyethylene glycol hydrogel sealant, and achieve hemostasis. |
| Time to Discharge Eligibility | Post Procedure | 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. |
| Procedural Success | 30 days post procedure | Defined as attainment of final hemostasis at all venous access sites without major venous access site closure-related complications through 30 days. |
Countries
United States
Participant flow
Recruitment details
Study enrollment began on 30Aug2022, and enrollment ended on 22May2023.
Pre-assignment details
352 subjects agreed to participate in the study following the completion of the informed consent process. Among 352 enrolled subjects, 44 were included as roll-in subjects, and 38 were screen failures. Both roll-in and screen-failed subjects were not assigned to either arm.
Participants by arm
| Arm | Count |
|---|---|
| MYNX CONTROL™ Venous VCD Patients received MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F. | 177 |
| Manual Compression Patients received Manual Compression in sealing femoral venous access sites.The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F. | 93 |
| Total | 270 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Physician Decision | 2 | 1 |
Baseline characteristics
| Characteristic | MYNX CONTROL™ Venous VCD | Manual Compression | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 116 Participants | 67 Participants | 183 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 26 Participants | 87 Participants |
| Age, Continuous | 66.7 Years STANDARD_DEVIATION 11.62 | 66.8 Years STANDARD_DEVIATION 10.63 | 66.7 Years STANDARD_DEVIATION 11.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 2 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 158 Participants | 87 Participants | 245 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 4 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 167 Participants | 89 Participants | 256 Participants |
| Region of Enrollment United States | 177 participants | 93 participants | 270 participants |
| Sex: Female, Male Female | 60 Participants | 32 Participants | 92 Participants |
| Sex: Female, Male Male | 117 Participants | 61 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 175 | 1 / 92 |
| other Total, other adverse events | 16 / 175 | 5 / 92 |
| serious Total, serious adverse events | 10 / 175 | 4 / 92 |
Outcome results
Primary
Primary Effectiveness Endpoint: Time to Ambulation
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.
Time frame: Post procedure
Population: Five (5) MYNX CONTROL VENOUS VCD subjects with missing data and Two (2) Manual Compression subjects with missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MYNX CONTROL™ VENOUS VCD | Primary Effectiveness Endpoint: Time to Ambulation | 2.6 hours | Standard Deviation 1.03 |
| Manual Compression | Primary Effectiveness Endpoint: Time to Ambulation | 5.1 hours | Standard Deviation 4.35 |
Comparison: Hypothesis: the time to ambulation for the subjects using the MYNX CONTROL™ Venous VCD was significantly less than for those where manual compression was used.p-value: <0.001t-test, 1 sided
Primary
Primary Effectiveness Endpoint: Time to Hemostasis
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).
Time frame: Post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MYNX CONTROL™ VENOUS VCD | Primary Effectiveness Endpoint: Time to Hemostasis | 2.1 minutes | Standard Deviation 1.79 |
| Manual Compression | Primary Effectiveness Endpoint: Time to Hemostasis | 11.4 minutes | Standard Deviation 7.19 |
Comparison: Hypothesis: the time to hemostasis for the MYNX CONTROL™ Venous VCD device is at least 5 minutes less than manual compression.p-value: <0.001Mixed Models Analysis
Primary
Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days
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.
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| MYNX CONTROL™ VENOUS VCD | Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days | 0 limbs |
| Manual Compression | Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days | 1 limbs |
Secondary
Device Success
Defined as the ability to successfully deploy the MYNX CONTROL™ VENOUS VCD delivery system, deliver the polyethylene glycol hydrogel sealant, and achieve hemostasis.
Time frame: During procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| MYNX CONTROL™ VENOUS VCD | Device Success | 470 access sites |
Secondary
Procedural Success
Defined as attainment of final hemostasis at all venous access sites without major venous access site closure-related complications through 30 days.
Time frame: 30 days post procedure
Population: Six (6) MYNX CONTROL VENOUS VCD subjects with missing data and three (3) Manual Compression subjects with missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MYNX CONTROL™ VENOUS VCD | Procedural Success | 171 Participants |
| Manual Compression | Procedural Success | 89 Participants |
Secondary
Secondary Safety Endpoints: Minor Complications of the Target Limb Access Site Within 30 Days
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.
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| MYNX CONTROL™ VENOUS VCD | Secondary Safety Endpoints: Minor Complications of the Target Limb Access Site Within 30 Days | 0 limbs |
| Manual Compression | Secondary Safety Endpoints: Minor Complications of the Target Limb Access Site Within 30 Days | 6 limbs |
Secondary
Time to Discharge Eligibility
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.
Time frame: Post Procedure
Population: There were 4 missing data in the MYNX CONTROL VENOUS VCD group and 2 missing data in the Manual Compression group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MYNX CONTROL™ VENOUS VCD | Time to Discharge Eligibility | 3.1 hours | Standard Deviation 1.24 |
| Manual Compression | Time to Discharge Eligibility | 5.5 hours | Standard Deviation 4.58 |
Comparison: Hypothesis: The time to discharge eligibility for the subjects using the MYNX CONTROL™ Venous VCD was significantly less than for those where manual compression was usedp-value: <0.001t-test, 1 sided