CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 172 enrolled
Drug / intervention
The Angel® Catheterdevice
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/NCT02186223
NCT02186223N/ACompleted
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The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects

BiO2 Medical·interventional·Posted Jul 10, 2014·Updated Apr 4, 2017

In Brief

A clinical study evaluating The Angel® Catheter for Pulmonary Embolism and 3 related conditions. Completed, enrolled 172 participants across 21 sites.

Detailed Summary

The primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism, Trauma
CountriesUnited States
CollaboratorsCardioMed Device Consultants, LLC, Intrinsic Imaging, LLC, Novella Clinical

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 10, 2014
Enrollment StartJan 1, 2015
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.0 years ago

Interventions

The Angel® Catheterdevice

The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.