CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 241 enrolled
Drug / intervention
CELT ACDdevice
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/NCT01600482
NCT01600482N/ACompleted
CompareCT.gov

Clinical Investigation Plan (CIP) for Safety and Efficacy Study of Arterial Closure Device (CELT ACD). Clinical Investigation Plan No.: CIP-TS-003

Vasorum Ltd·interventional·Posted May 17, 2012·Updated Aug 23, 2017

In Brief

A clinical study evaluating CELT ACD for Cardiac Disease and Coronary Artery Disease. Completed, enrolled 241 participants across 5 sites in 3 countries.

Detailed Summary

The objective of the CELT ACD® Vascular Closure Device study is to evaluate the safety and effectiveness of the CELT ACD® device to achieve hemostasis of the common femoral artery access site in patients on anticoagulation who are undergoing a percutaneous intervention (PCI) procedure using a 6F sheath.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Disease, Coronary Artery Disease
CountriesGermany, Ireland, United States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 17, 2012
Enrollment StartMay 1, 2012
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.1 years ago

Interventions

CELT ACDdevice

The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous intervention procedure using a 6F procedural sheath.