Trial Outcomes & Findings for AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) (NCT NCT03573206)

NCT ID: NCT03573206

Last Updated: 2023-03-10

Results Overview

Final hemostasis at all venous access sites and freedom from major venous access site closure-related complications through 30 days follow-up

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 168 participants
• Primary outcome timeframe: 30 (+/- 10) days post-procedure
• Results posted on: 2023-03-10

Participant Flow

Participant milestones

Measure	Treatment Arm Cardiva Medical Mid-Bore VVCS for venous femoral access site closure Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case.
Overall Study STARTED	168
Overall Study COMPLETED	168
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)

Baseline characteristics by cohort

Measure	Treatment Arm n=168 Participants Cardiva Medical Mid-Bore VVCS for venous femoral access site closure Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case.
Age, Continuous	64.3 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	164 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	158 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
BMI (Body Mass Index)	28.8 kg/m^2 STANDARD_DEVIATION 5.6 • n=5 Participants

PRIMARY outcome

Timeframe: 30 (+/- 10) days post-procedure

Final hemostasis at all venous access sites and freedom from major venous access site closure-related complications through 30 days follow-up

Outcome measures

Measure	Treatment Arm n=168 Participants Cardiva Medical Mid-Bore VVCS for venous femoral access site closure Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case.
Number of Participants With Overall Procedure Success - Effectiveness	168 Participants

PRIMARY outcome

Timeframe: 30 (+/- 10) 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.

Outcome measures

Measure	Treatment Arm n=168 Participants Cardiva Medical Mid-Bore VVCS for venous femoral access site closure Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case.
Major Venous Access Site Closure-related Complications - Safety, Number of Limbs With Each Event	0 Participants

SECONDARY outcome

Timeframe: From start of procedure through successful ambulation, assessed to be within 6 hours of final hemostasis

No peri-procedural urinary catheter insertion required through successful Ambulation (per-patient analyses)

Outcome measures

Measure	Treatment Arm n=165 Participants Cardiva Medical Mid-Bore VVCS for venous femoral access site closure Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case.
Study Group Success Rate - No Urinary Catheter Group, Number of Participants	161 Participants

SECONDARY outcome

Timeframe: From time of final hemostasis through successful ambulation, assessed to be within 6 hours of final hemostasis

No delay in Ambulation due to access site bleeding in subjects who receive heparin but are not reversed with protamine (per-patient analyses)

Outcome measures

Measure	Treatment Arm n=41 Participants Cardiva Medical Mid-Bore VVCS for venous femoral access site closure Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case.
Study Group Success Rate - No Protamine Group, Number of Participants	39 Participants

SECONDARY outcome

Timeframe: Within 72 hours post-discharge

Discharge within the same calendar day from the start of the procedure without the need for re-hospitalization within 72 hours of hospital discharge due to access site complications (per-patient analyses)

Outcome measures

Measure	Treatment Arm n=18 Participants Cardiva Medical Mid-Bore VVCS for venous femoral access site closure Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case.
Study Group Success Rate - Same Calendar Day Discharge Group, Number of Participants	18 Participants

SECONDARY outcome

Timeframe: Evaluated for each access site immediately after device delivery is attempted, reported within 5 minutes of deployment

The ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per-access site analyses)

Outcome measures

Measure	Treatment Arm n=622 devices Cardiva Medical Mid-Bore VVCS for venous femoral access site closure Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case.
Number of Devices With Success	612 devices

SECONDARY outcome

Timeframe: 30 (+/- 10) 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.

Outcome measures

Measure	Treatment Arm n=325 limbs Cardiva Medical Mid-Bore VVCS for venous femoral access site closure Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case.
Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event	318 limbs

Adverse Events

Treatment Arm

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Arm n=168 participants at risk Cardiva Medical Mid-Bore VVCS for venous femoral access site closure Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case.
Blood and lymphatic system disorders Access site closure-related serious adverse events, excluding major and minor complications	0.60% 1/168 • Number of events 1 • 30 days (± 10 days) Access-site related adverse events included
Blood and lymphatic system disorders Access site closure-related serious adverse events, including minor complications	0.60% 1/168 • Number of events 1 • 30 days (± 10 days) Access-site related adverse events included
Cardiac disorders Access site closure-related serious adverse events, including minor complications	0.60% 1/168 • Number of events 1 • 30 days (± 10 days) Access-site related adverse events included

Other adverse events

Measure	Treatment Arm n=168 participants at risk Cardiva Medical Mid-Bore VVCS for venous femoral access site closure Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case.
Blood and lymphatic system disorders Access site venous re-bleeding after initial hemostasis confirmed for 5 minutes	2.4% 4/168 • Number of events 7 • 30 days (± 10 days) Access-site related adverse events included
Surgical and medical procedures Access site-related tissue tract oozing - prolonged*	0.60% 1/168 • Number of events 1 • 30 days (± 10 days) Access-site related adverse events included
Blood and lymphatic system disorders Access site hematoma ≤ 6 cm	1.8% 3/168 • Number of events 3 • 30 days (± 10 days) Access-site related adverse events included
Surgical and medical procedures Bruising at the access site*	0.60% 1/168 • Number of events 1 • 30 days (± 10 days) Access-site related adverse events included
Surgical and medical procedures Pain at the access site	0.60% 1/168 • Number of events 1 • 30 days (± 10 days) Access-site related adverse events included

Additional Information

Terry Alverson, Director of Regulatory and Clinical

Cardiva Medical

Phone: 650-207-0563

Email: Terry_Alverson@cardivamedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60