Surgical Wound
Conditions
Keywords
arteriotomy, vessel closure, femoral access site
Brief summary
The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.
Detailed description
The objective of the trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System (VSS) in sealing femoral arterial access sites and providing reduced times to hemostasis (TTH) compared with performance goals at the completion of diagnostic or interventional procedures performed through 5, 6 or 7 Fr procedural sheaths. This study will be considered a success (from a statistical perspective) if it meets both the Closer VSS superiority goal for the primary effectiveness analysis and the Closer VSS performance goal for the primary safety analysis.
Interventions
DEVICECloser VSS
At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Sponsors
Rex Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Pre-Op Inclusion Criteria: 1 - Acceptable candidates for an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 5, 6, or 7 Fr introducer sheath. \-
Exclusion criteria
Pre-Operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis | procedural, usually within 15 minutes of enrollment | Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis |
| Rate of Combined Major Access Site Closure-related Complications | Through 30 days +/- 7 days | Primary safety endpoint - rate of combined major access site closure-related complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hospital Discharge | through hospital discharge, usually within 24 hours | Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward |
| Device Success | procedural, usually within 15 minutes of enrollment | Secondary efficacy endpoint - the ability to deploy the system, deliver the implant, and achieve arterial hemostasis with the Closer VSS alone or with post-hemostasis adjunctive compression |
| Time to Ambulation | prior to hospital discharge, usually within 24 hours | Secondary efficacy endpoint - elapsed time between the Closer VSS delivery system removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site |
| Procedure Success | through 30 days +/- 7 days | Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days |
| Rate of Combined Minor Access Site Closure-related Complications | through 30 +/- 7 days | Secondary safety endpoint - rate of combined minor access site closure-related complications |
| Time to Discharge Eligibility | prior to hospital discharge, usually within 24 hours | Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject's access site is assessed to be hemodynamically stable, as determined by the investigator or his/her designee(s) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Closer VSS - Diagnostic Cohort Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in diagnostic endovascular cases.
Closer VSS: At the end of a percutaneous diagnostic endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis. | 111 |
| Closer VSS - Interventional Cohort Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in interventional endovascular cases.
Closer VSS: At the end of a percutaneous interventional endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis. | 109 |
| Total | 220 |
Baseline characteristics
| Characteristic | Closer VSS - Diagnostic Cohort | Closer VSS - Interventional Cohort | Total |
|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 10.3 | 64.7 years STANDARD_DEVIATION 8.7 | 63.9 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 45 Participants | 25 Participants | 70 Participants |
| Sex: Female, Male Male | 66 Participants | 84 Participants | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 220 |
| serious Total, serious adverse events | 0 / 220 |
Outcome results
Primary
Rate of Combined Major Access Site Closure-related Complications
Primary safety endpoint - rate of combined major access site closure-related complications
Time frame: Through 30 days +/- 7 days
Population: All subjects enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closer VSS | Rate of Combined Major Access Site Closure-related Complications | 0 complications |
Primary
Time to Hemostasis
Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis
Time frame: procedural, usually within 15 minutes of enrollment
Population: All subjects enrolled
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Closer VSS | Time to Hemostasis | 1.78 minutes |
Secondary
Device Success
Secondary efficacy endpoint - the ability to deploy the system, deliver the implant, and achieve arterial hemostasis with the Closer VSS alone or with post-hemostasis adjunctive compression
Time frame: procedural, usually within 15 minutes of enrollment
Population: All subjects enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closer VSS | Device Success | 216 Participants |
Secondary
Procedure Success
Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days
Time frame: through 30 days +/- 7 days
Population: All subjects enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closer VSS | Procedure Success | 219 Participants |
Secondary
Rate of Combined Minor Access Site Closure-related Complications
Secondary safety endpoint - rate of combined minor access site closure-related complications
Time frame: through 30 +/- 7 days
Population: All subjects enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closer VSS | Rate of Combined Minor Access Site Closure-related Complications | 3 complications |
Secondary
Time to Ambulation
Secondary efficacy endpoint - elapsed time between the Closer VSS delivery system removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site
Time frame: prior to hospital discharge, usually within 24 hours
Population: All subjects enrolled
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Closer VSS | Time to Ambulation | 2.50 hours |
Secondary
Time to Discharge Eligibility
Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject's access site is assessed to be hemodynamically stable, as determined by the investigator or his/her designee(s)
Time frame: prior to hospital discharge, usually within 24 hours
Population: All subjects enrolled
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Closer VSS | Time to Discharge Eligibility | 2.83 hours |
Secondary
Time to Hospital Discharge
Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward
Time frame: through hospital discharge, usually within 24 hours
Population: All subjects enrolled
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Closer VSS | Time to Hospital Discharge | 13.12 hours |