Last updated on April 2018

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


Brief description of study

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.

Detailed Study Description

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.

The Vanguard System has been designed to revascularize iliac and femoro-popliteal PAD while protecting against embolization at the same time. It is the first system in which the embolic protection filter is coupled on the same catheter as the angioplasty balloon for use in the lower extremities. Up to 130 patients will be enrolled into this study and followed for 30 days after post-procedure. Adult patients with lifestyle-limiting claudication or rest pain (Rutherford categories 2 to 3) who meet all eligibility criteria will be approached for participation in the trial.

Clinical Study Identifier: NCT03271710

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Leiven Maene, MD

OLV Hospital Aalst
Aalst, Belgium
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Jürgen Verbist, MD

Imelda Hospital / Vascular Science Research Center
Bonheiden, Belgium
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Koen Deloose, MD

AZ Sint Blasius
Dendermonde, Belgium
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Koen Keirse, MD

RZ Heilig Hart Hospital
Tienen, Belgium
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Thomas Zeller, Prof.

Interventional Cardiology and Vascular Medicine, Department of Angiology, Universit ts-Herzzentrum Freiburg
Bad Krozingen, Germany
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Ralf Langhoff, MD

Sankt Gertrauden-Krankenhaus
Berlin, Germany
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Stefan Müller-Hülsbeck, Prof.

Daikonissenkrankenhaus Flensburg
Flensburg, Germany
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Joachim Schofer, MD

MVZ/Prof. Mathey Prof. Schofer Clinic
Hamburg, Germany
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Dierk Scheinert, Prof.

Universit tsklinikum Leipzig
Leipzig, Germany
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