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

NAUnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 11, 2019

Primary Completion Date

August 30, 2020

Study Completion Date

August 30, 2021

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"

Trial Locations (5)

11525

251 Airforce General Hospital, Athens

12462

University General Hospital Attikon, Athens

26504

University General Hospital of Patras,, Pátrai

54635

"General Hospital of Thessaloniki G. Gennimatas", Thessaloniki

Unknown

Uniiversity Hospital of Larisa, Larissa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharmassist Ltd

INDUSTRY

lead

Rontis Hellas SA

INDUSTRY

NCT04821388 - Α Pre CE-Marking Study Using the Rontis Drug Coated Balloon for Treatment of Lesions in Femoropopliteal Arteries | Biotech Hunter | Biotech Hunter