CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 168 enrolled
Drug / intervention
Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)device
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/NCT03573206
NCT03573206N/ACompleted
CompareCT.gov

Multi-center, Single Arm Continued Access Protocol to Evaluate the Mid-Bore Venous VCS for the Management of the Femoral Venotomy After Catheter-based Interventions Via 6-12F Procedural Sheaths With Single or Multiple Access Sites Per Limb

Cardiva Medical, Inc.·interventional·Posted Jun 29, 2018·Updated Mar 10, 2023

In Brief

A clinical study evaluating Cardiva Mid-Bore Venous Vascular Closure Device (VVCS) for Surgical Wound. Completed, enrolled 168 participants across 3 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 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.

Study Details

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

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 29, 2018
Enrollment StartAug 27, 2018
Primary CompletionJan 14, 2019
Study CompletionMar 31, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.0 years ago

Interventions

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

The device will be used to close all femoral venous access sites at the end of the case.