Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access

NACompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

June 29, 2022

Primary Completion Date

September 22, 2023

Study Completion Date

November 13, 2023

Conditions
Peripheral Arterial Disease
Interventions
DEVICE

S.M.A.R.T. RADIANZ™ Vascular Stent System

The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.

DEVICE

BRITE TIP RADIANZ™ Guiding Sheath

BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.

DEVICE

SABERX RADIANZ™ PTA Balloon Catheter

SABERX RADIANZ™ is a catheter with a distal inflatable balloon.

Trial Locations (12)

Unknown

Univ Klinikum LKG Graz, Graz

Klinikum Klagenfurt am Wörtherse, Klagenfurt

Hanusch Krankenhaus, Vienna

Univ.-Klinik für Innere Medizin II, Vienna

A.Z. Sint-Blasius Hospital-Dendermonde, Dendermonde

Hospital Ambroise Pare, Boulogne-Billancourt

Groupe Hôpital Paris St Joseph, Paris

Clinique Rhena, Strasbourg

Clinique Pasteur, Toulouse

Maria Cecilia Hospital, Cotignola

Hosp Univ. de Guadalajara, Guadalajara

Kantonsspital Winterthur, Winterthur

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Qserve

INDUSTRY

collaborator

NAMSA

OTHER

lead

Cordis Corporation

INDUSTRY

NCT05399680 - Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access | Biotech Hunter | Biotech Hunter