NCT03271710

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

A Single-Arm, Multicenter Study for the Lower Extremities Using the Vanguard IEP Peripheral Balloon Angioplasty System With Integrated Embolic Protection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Contego Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	peripheral balloon angioplasty	Percutaneous transluminal angioplasty (PTA) of the lower extremities

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-11-30
• Completion: 2018-12-30
• First posted: 2017-09-05
• Last updated: 2019-07-10

Locations

9 sites across 2 countries: Belgium, Germany