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Clinical Studies

FDA Approved IDE Pivotal Trial: The Angel® Catheter Clinical Trial

Primary Objective:

This landmark investigation was concluded in December 2015. The primary objective of this clinical trial was 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.

Study Information:

  • Single arm, multicenter, prospective study.
  • 26 research trauma centers level I and II across the U.S.
  • A total of 172 subjects were consented across the United States. The device was successfully placed in 163 eligible subjects [intention-to-treat (ITT) population], 151 of these subjects had the device in place for at least 48 hours [per-protocol (PP) population].
  • The most common indication for placement of the device was recognized contraindication to the use of anticoagulation in 160/163 (98.2%) of subjects.

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FDA Approved IDE Early Feasibility Pilot Study

This IDE-approved study was concluded in July 2014 under the FDA’s Early Feasibility Pilot Program. The primary objective of this clinical trial was to obtain insights into the safety of the Angel® Catheter in critically ill subjects at high risk of venous thromboembolism (VTE) disease AND who were not receiving pharmacological thromboprophylaxis. Interim study data on the first five (5) subjects supported the Pivotal Trial IDE application and request for early termination of the Early Feasibility Study. Both received FDA approval.

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Post Market Clinical Follow Up: European Registry

Completed in August 2014, this observational, multi-center registry assessed the performance, safety and utility of the Angel® Catheter in general clinical practice. Eight (8) institutions across the European Union participated, and shared their experience with the Angel® Catheter in a total of sixty (60) critically ill patients.

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Pilot Clinical Study-Colombia

Conducted in early 2012, this study provided preliminary safety data for the Angel® Catheter in patients who have a temporary risk of pulmonary embolism, and temporary or absolute contraindications to anticoagulation.

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