MedTrace Logo

TORUS I Clinical Study

NCT03128424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-29

Study results available
· View outcomes & findings →

Summary

The primary objective of the feasibility study is to evaluate the safety and effectiveness of the PQ Bypass Stent Graft System in the treatment of atherosclerotic lesions of the native superficial femoral artery (SFA) or the superficial femoral and proximal popliteal arteries.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

PQ Bypass Stent Graft System

The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.

Sponsors & Collaborators

  • 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
2016-02-29
Primary Completion
2020-07-31
Completion
2021-09-30
FDA Device
Yes

More Related Trials

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 NCT03128424 on ClinicalTrials.gov