CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 204 enrolled
Drug / intervention
Cardiva Mid-Bore VVCS +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03193021
NCT03193021N/ACompleted
CompareCT.gov

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

Cardiva Medical, Inc.·interventional·Posted Jun 20, 2017·Updated Mar 10, 2023

In Brief

A clinical study evaluating Cardiva Mid-Bore VVCS and Manual compression for Surgical Wound. Completed, enrolled 204 participants across 13 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgical Wound
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 20, 2017
Enrollment StartSep 20, 2017
Primary CompletionApr 13, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.0 years ago

Interventions

Cardiva Mid-Bore VVCSdevice

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 compressionother

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.