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TORUS 2 IDE Clinical Study

NCT04130737 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2024-03-07

No results posted yet for this study

Summary

The primary objective of the TORUS 2 IDE Clinical Study is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the native SFA or the superficial femoral and/or proximal popliteal arteries.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

TORUS Stent Graft System

The TORUS Stent Graft is an intravascular prosthesis intended to improve blood flow in the area in which it is implanted and the TORUS Stent Graft Delivery System is a standard pin-and-pull delivery system used to implant the SG in the desired area. Use of the TORUS Stent Graft allows for improving blood flow in the peripheral vasculature.

Sponsors & Collaborators

  • Syntactx

    collaborator NETWORK

  • PQ Bypass, Inc.

    collaborator INDUSTRY

  • Endologix

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2023-01-06
Completion
2024-12-24
FDA Device
Yes

Countries

  • United States

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 NCT04130737 on ClinicalTrials.gov