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Study to Evaluate the Lower Extremity Intervention With Integrated Embolic Protection Using the Vanguard IEP System

NCT03271710 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2019-07-10

No results posted yet for this study

Summary

The ENTRAP Study is a prospective, multi-center, non-randomized, single-arm, study with follow-up to 30 days to determine the acute safety, acute device performance and clinical performance of the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection. The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for peripheral vascular percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty for the femoral, iliac, popliteal and profunda arteries.

Conditions

  • Peripheral Arterial Disease
  • Intermittent Claudication
  • Atherosclerosis of Femoral Artery

Interventions

DEVICE

peripheral balloon angioplasty

Percutaneous transluminal angioplasty (PTA) of the lower extremities

Sponsors & Collaborators

  • Contego Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Zeller, Prof. · Universitäts-Herzzentrum Freiburg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2018-11-30
Completion
2018-12-30

Countries

  • Belgium
  • Germany

Study Locations

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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 NCT03271710 on ClinicalTrials.gov