Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)

NCT01600482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2017-08-23

Study results available
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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.

Conditions

Interventions

DEVICE

CELT ACD

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.

Sponsors & Collaborators

  • Vasorum Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States
  • Germany
  • Ireland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01600482 on ClinicalTrials.gov