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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

NCT05399680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2025-08-11

Study results available
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Summary

The primary objective of this clinical investigation was to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ Nitinol Stent, in the treatment of patients with obstructive iliac or femoropopliteal arterial disease via radial artery access.

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.

Sponsors & Collaborators

  • Qserve

    collaborator INDUSTRY

  • NAMSA

    collaborator OTHER

  • Cordis Corporation

    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
2022-06-29
Primary Completion
2023-09-22
Completion
2023-11-13
FDA Device
Yes

Countries

  • Austria
  • Belgium
  • France
  • Italy
  • Spain
  • Switzerland

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 NCT05399680 on ClinicalTrials.gov