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Completed

NCT Number: NCT03193021

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

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.

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Key information

Conditions

Surgical Wound Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alaska Heart & Vascular, Anchorage, Alaska, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiva Mid-Bore VVCS

Device

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.

Manual compression

Other

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.

Primary outcomes

  1. Time to Ambulation (TTA)

    Time frame: 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.

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Time to Discharge Eligibility (TTDE)

    Time frame: 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

  3. Time to Hemostasis (TTH)

    Time frame: 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.

  4. Time to Discharge (TTD)

    Time frame: 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

  5. Time to Closure Eligibility (TTCE)

    Time frame: 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)

  6. Total Post-Procedure Time (TPPT)

    Time frame: 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

  7. Number of Participants With Procedure Success

    Time frame: 30 +/- 7 days post-procedure

    Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications

  8. Number of Access Sites With Device Success

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Cardiva Medical, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2017
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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