HORIZON Prospective Clinical Investigation

NATerminatedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

December 15, 2021

Primary Completion Date

November 17, 2023

Study Completion Date

November 17, 2023

Conditions
Peripheral Arterial Disease
Interventions
DEVICE

EXIST 6F NiTi Stent System FLEX

Subjects requiring treatment of the P1 segment of the proximal popliteal artery will be treated with the Exist 6F NiTi Stent FLEX type. Subjects requiring treatment of the SFA will undergo an additional calcification review based on the Fanelli classification. Subjects graded with Fanelli 1 or 2 will be treated with the Exist 6F NiTi Stent FLEX type.

DEVICE

EXIST 6F NiTi Stent System PULL

Subjects requiring treatment of the SFA will undergo a calcification review based on the Fanelli classification. Subjects graded with Fanelli grade 3 and 4 will be treated with the Exist 6F NiTi Stent PULL type.

Trial Locations (2)

95123

University Hospital of Catania, Catania

15-276

University Clinical Hospital of Bialystok, Bialystok

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Policlinico di Monza

UNKNOWN

collaborator

University Clinical Hospital of Bialystok

UNKNOWN

collaborator

University Hospital, Catania

OTHER

collaborator

Erasmus Medical Center

OTHER

collaborator

University Hospital, Geneva

OTHER

lead

Qmedics AG

INDUSTRY

NCT05234164 - HORIZON Prospective Clinical Investigation | Biotech Hunter | Biotech Hunter