Surgical Wound
Conditions
Keywords
vessel closure, venous access site, femoral venotomy, medium bore, multiple access sites
Brief summary
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA) compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.
Detailed description
A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing multiple femoral venous access sites and providing reduced times to ambulation compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths. Only patients with multiple access sites will be enrolled in order to support the desired indication. Randomization will be stratified to account for patients with varying numbers of access sites in a 1:1 treatment device to control arm ratio to ensure treatment and control arms have the same proportion of access sites/patient, i.e. 3 access sites/patient vs. 4 access sites/patient.
Interventions
DEVICECardiva Mid-Bore VVCS
The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.
OTHERManual compression
Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Sponsors
Cardiva Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data Safety Monitoring Committee will adjudicate endpoint events, blinded to treatment assignment when possible
Intervention model description
Subjects randomized in 1:1 fashion to either Cardiva Mid-Bore Venous Vascular Closure Device (VVCD) or manual compression for multiple venous access site hemostasis
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Acceptable candidate for an elective, non-emergent catheter-based procedure via the common femoral vein(s) using a 6 to 12 Fr inner diameter introducer sheath, with a minimum of 3 and maximum of 4 femoral venous access sites, and a maximum of 2 access sites/leg * Anticipated prolonged bedrest (5 hours or more) and / or overnight stay
Exclusion criteria
* Active systemic or cutaneous infection, or inflammation in vicinity of the groin * Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids * Know history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count \< 100,000 cells/mm3 * Severe co-existing morbidities with life expectancy less than 12 months * Femoral arteriotomy or femoral venotomy in \< 10 days, or with any known vascular complications or residual hematoma, or with use of an intravascular closure device w/in previous 30 days * Planned femoral venous or arterial access within next 30 days * History of DVT, pulmonary embolism or thrombophlebitis * Significant anemia or renal insufficiency * BMI \> 45 kg/m2 or \< 20 kg/m2 * Unable to routinely walk at least 20 ft. without assistance * LMWH within 8 hours before or after procedure * Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath; \< 6 Fr or \> 12 Fr inner diameter sheath use; obvious bleeding complications or tissue tract estimated to be \< 2.5 cm deep
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Ambulation (TTA) | Post-procedure, usually within 6 hours | Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject stands and walks 20 feet without evidence of venous re-bleeding from the femoral access site. |
| Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event | 30 +/- 7 days post-procedure | Rate of combined major venous access site closure-related complications. The method used to determine what would be considered major venous access site closure-related complications are those complications which were attributed directly to the closure method used for the access site at the end of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis (TTH) | Post-procedure, usually within 3 hours | Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and first observed and confirmed venous hemostasis, for each access site. |
| Time to Discharge (TTD) | Prior to hospital discharge, usually within 24 hours | Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is discharged |
| Time to Closure Eligibility (TTCE) | Post-procedure, usually within 6 hours | Elapsed time between removal of the last procedural device for the index procedure and removal of the first Mid-Bore VVCS device (treatment arm) or removal of first sheath (control arm) |
| Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event | 30 +/- 7 days post-procedure | Rate of combined minor venous access site closure-related complications. The method used to determine what would be considered minor venous access site closure-related complications are those complications which were attributed directly to the closure method used for the access site at the end of the procedure. |
| Number of Participants With Procedure Success | 30 +/- 7 days post-procedure | Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications |
| Number of Access Sites With Device Success | Procedural, usually within 15 minutes of enrollment | Ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per access site analysis, treatment arm only) |
| Total Post-Procedure Time (TPPT) | Post-procedure, usually within 6 hours | Elapsed time between removal of the last procedural device for the index procedure and when the subject is able to successfully ambulate |
| Time to Discharge Eligibility (TTDE) | Prior to hospital discharge, usually within 24 hours | Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is eligible for discharge based solely on assessment of the access site |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardiva Mid-Bore VVCS Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case.
Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient. | 100 |
| Manual Compression Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case.
Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient. | 104 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Cardiva Mid-Bore VVCS | Manual Compression | Total |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 11.6 | 63.4 years STANDARD_DEVIATION 11.1 | 62.5 years STANDARD_DEVIATION 11.3 |
| BMI | 29.5 kg/m^2 STANDARD_DEVIATION 4.5 | 29.7 kg/m^2 STANDARD_DEVIATION 5.2 | 29.6 kg/m^2 STANDARD_DEVIATION 4.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants | 95 Participants | 192 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 4 Participants | 10 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 | 6 Participants | 9 Participants |
| Race (NIH/OMB) White | 86 Participants | 93 Participants | 179 Participants |
| Region of Enrollment United States | 100 participants | 104 participants | 204 participants |
| Sex: Female, Male Female | 33 Participants | 40 Participants | 73 Participants |
| Sex: Female, Male Male | 67 Participants | 64 Participants | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 104 |
| other Total, other adverse events | 0 / 100 | 0 / 104 |
| serious Total, serious adverse events | 9 / 100 | 2 / 104 |
Outcome results
Primary
Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event
Rate of combined major venous access site closure-related complications. The method used to determine what would be considered major venous access site closure-related complications are those complications which were attributed directly to the closure method used for the access site at the end of the procedure.
Time frame: 30 +/- 7 days post-procedure
Population: Major Venous Access Site Closure-Related Complications, Number of Limbs with Each Event
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiva Mid-Bore VVCS | Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event | 0 major complications |
| Manual Compression | Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event | 0 major complications |
Primary
Time to Ambulation (TTA)
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject stands and walks 20 feet without evidence of venous re-bleeding from the femoral access site.
Time frame: Post-procedure, usually within 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardiva Mid-Bore VVCS | Time to Ambulation (TTA) | 2.8 hours | Standard Deviation 1.3 |
| Manual Compression | Time to Ambulation (TTA) | 6.1 hours | Standard Deviation 1.6 |
Secondary
Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event
Rate of combined minor venous access site closure-related complications. The method used to determine what would be considered minor venous access site closure-related complications are those complications which were attributed directly to the closure method used for the access site at the end of the procedure.
Time frame: 30 +/- 7 days post-procedure
Population: Combined Venous Access Site Closure-Related Complications, As Reported, Number of Limbs with Each Event
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiva Mid-Bore VVCS | Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event | 2 minor complications |
| Manual Compression | Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event | 5 minor complications |
Secondary
Number of Access Sites With Device Success
Ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per access site analysis, treatment arm only)
Time frame: Procedural, usually within 15 minutes of enrollment
Population: Number of access sites where device insertion was attempted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiva Mid-Bore VVCS | Number of Access Sites With Device Success | 351 Successful Femoral Access Sites |
Secondary
Number of Participants With Procedure Success
Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications
Time frame: 30 +/- 7 days post-procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cardiva Mid-Bore VVCS | Number of Participants With Procedure Success | Study Subjects | 98 Participants |
| Cardiva Mid-Bore VVCS | Number of Participants With Procedure Success | LTF | 2 Participants |
| Manual Compression | Number of Participants With Procedure Success | Study Subjects | 103 Participants |
| Manual Compression | Number of Participants With Procedure Success | LTF | 1 Participants |
Secondary
Time to Closure Eligibility (TTCE)
Elapsed time between removal of the last procedural device for the index procedure and removal of the first Mid-Bore VVCS device (treatment arm) or removal of first sheath (control arm)
Time frame: Post-procedure, usually within 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardiva Mid-Bore VVCS | Time to Closure Eligibility (TTCE) | 10.5 minutes | Standard Deviation 6 |
| Manual Compression | Time to Closure Eligibility (TTCE) | 37.6 minutes | Standard Deviation 33.2 |
Secondary
Time to Discharge Eligibility (TTDE)
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is eligible for discharge based solely on assessment of the access site
Time frame: Prior to hospital discharge, usually within 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardiva Mid-Bore VVCS | Time to Discharge Eligibility (TTDE) | 3.1 hours | Standard Deviation 1.3 |
| Manual Compression | Time to Discharge Eligibility (TTDE) | 6.5 hours | Standard Deviation 1.9 |
Secondary
Time to Discharge (TTD)
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is discharged
Time frame: Prior to hospital discharge, usually within 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardiva Mid-Bore VVCS | Time to Discharge (TTD) | 21.8 hours | Standard Deviation 13.4 |
| Manual Compression | Time to Discharge (TTD) | 21.8 hours | Standard Deviation 9.5 |
Secondary
Time to Hemostasis (TTH)
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and first observed and confirmed venous hemostasis, for each access site.
Time frame: Post-procedure, usually within 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardiva Mid-Bore VVCS | Time to Hemostasis (TTH) | 6.1 minutes | Standard Deviation 3.7 |
| Manual Compression | Time to Hemostasis (TTH) | 13.7 minutes | Standard Deviation 6.5 |
Secondary
Total Post-Procedure Time (TPPT)
Elapsed time between removal of the last procedural device for the index procedure and when the subject is able to successfully ambulate
Time frame: Post-procedure, usually within 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardiva Mid-Bore VVCS | Total Post-Procedure Time (TPPT) | 3.1 hours | Standard Deviation 1.3 |
| Manual Compression | Total Post-Procedure Time (TPPT) | 6.8 hours | Standard Deviation 1.7 |