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Α Pre CE-Marking Study Using the Rontis Drug Coated Balloon for Treatment of Lesions in Femoropopliteal Arteries

NCT04821388 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-03-29

No results posted yet for this study

Summary

The Rontis Drug Coated - Peripheral Balloon Catheter is intended for PTA procedure on atherosclerotically stenotic or obstructed vessels and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae in order to improve the perfusion and decrease the incidence of restenosis.

In this study, it is intended to use Rontis DCB for treatment of lesions in the femoropopliteal arteries.

Conditions

  • Peripheral Artery Disease (PAD)

Interventions

DEVICE

Rontis DCB

The Rontis DCB is intended for use as a percutaneous transluminal angioplasty (PTA) catheter to dilate stenotic or obstructive vascular lesions in the lower extremities for the purpose of improving limb perfusion and decreasing the incidence of restenosis. In this study, it is intended to use Rontis DCB for treatment of lesions in the femoropopliteal arteries

Sponsors & Collaborators

  • Pharmassist Ltd

    collaborator INDUSTRY

  • Rontis Hellas SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-11
Primary Completion
2020-08-30
Completion
2021-08-30

Countries

  • Greece

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 NCT04821388 on ClinicalTrials.gov