NCT03573206

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

Completed NA Results posted Last updated 10 March 2023

What this trial tests

NA trial testing Cardiva Mid-Bore Venous Vascular Closure Device (VVCS) in Surgical Wound in 168 participants. Completed in 31 March 2019.

Timeline

27 August 2018

Primary endpoint
14 January 2019

31 March 2019

Quick facts

Lead sponsor	Cardiva Medical, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	168
Start date	27 August 2018
Primary completion	14 January 2019
Estimated completion	31 March 2019
Sites	3 locations across United States

Drugs / interventions tested

• Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)

Conditions studied

• Surgical Wound — all drugs for Surgical Wound →

Sponsor

Cardiva Medical, Inc.

Who can join

18 and older, any sex, with Surgical Wound. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Overall Procedure Success - Effectiveness Primary · 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

Group	Value	95% CI
Treatment Arm	168

Major Venous Access Site Closure-related Complications - Safety, Number of Limbs With Each Event Primary · 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.

Group	Value	95% CI
Treatment Arm	0

Study Group Success Rate - No Urinary Catheter Group, Number of Participants Secondary · 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)

Group	Value	95% CI
Treatment Arm	161

Study Group Success Rate - No Protamine Group, Number of Participants Secondary · 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)

Group	Value	95% CI
Treatment Arm	39

Study Group Success Rate - Same Calendar Day Discharge Group, Number of Participants Secondary · 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)

Group	Value	95% CI
Treatment Arm	18

Number of Devices With Success Secondary · 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)

Group	Value	95% CI
Treatment Arm	612

Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event Secondary · 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.

Group	Value	95% CI
Treatment Arm	318

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days (± 10 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Arm

Serious: 3/168 (2%)

Deaths: 0/168

Serious adverse events (3 terms)

Reaction	System	Treatment Arm
Access site closure-related serious adverse events, excluding major and minor complications	Blood and lymphatic system disorders	—
Access site closure-related serious adverse events, including minor complications	Blood and lymphatic system disorders	—
Access site closure-related serious adverse events, including minor complications	Cardiac disorders	—

Other adverse events (5 terms — click to expand)

Reaction	System	Treatment Arm
Access site venous re-bleeding after initial hemostasis confirmed for 5 minutes	Blood and lymphatic system disorders	—
Access site hematoma ≤ 6 cm	Blood and lymphatic system disorders	—
Access site-related tissue tract oozing - prolonged*	Surgical and medical procedures	—
Bruising at the access site*	Surgical and medical procedures	—
Pain at the access site	Surgical and medical procedures	—

Most-reported serious reactions: Access site closure-related serious adverse events, excluding major and minor complications, Access site closure-related serious adverse events, including minor complications, Access site closure-related serious adverse events, including minor complications.

Data from ClinicalTrials.gov NCT03573206 adverse events section.

Sponsor's own description

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 at the completion of catheter-based procedures performed through 6-12 Fr introducer sheath, while allowing for one or more of the following: elimination of the Foley catheter, elimination of protamine, or allowing same (calendar) day discharge for the appropriate patient population.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.