AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID

Surgical Wound Clinical Trial

Official title:

AMBULATE: Multi-center, RCT for Safety & Efficacy of Cardiva Mid-Bore Venous VCS v. Manual Compression to Close Femoral Venotomies After Catheter-based Interventions Via 6-12F ID Sheaths With Single or Multiple Access Sites Per Limb

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193021
• Other study ID #: PTL 0508
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: April 13, 2018

Study information

• Verified date: February 2023
• Source: Cardiva Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: April 13, 2018
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Alaska Heart & Vascular	Anchorage	Alaska
United States	Emory St. Joseph's Hospital	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	University of Chicago	Chicago	Illinois
United States	Intermountain Health Care	Murray	Utah
United States	Centennial Medical Center	Nashville	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Mercy General Hospital	Sacramento	California
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	Stanford University Hospital	Stanford	California
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Cardiva Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Post-procedure, usually within 6 hours
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.	30 +/- 7 days post-procedure
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.	30 +/- 7 days post-procedure
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	Prior to hospital discharge, usually within 24 hours
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.	Post-procedure, usually within 3 hours
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	Prior to hospital discharge, usually within 24 hours
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)	Post-procedure, usually within 6 hours
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	Post-procedure, usually within 6 hours
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	30 +/- 7 days post-procedure
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)	Procedural, usually within 15 minutes of enrollment