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Prospective Multicenter Study to Confirm the Performance of the Renzan Stent in Treatment of SFA/POP Artery Disease

NCT04546477 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2023-08-25

No results posted yet for this study

Summary

The primary objective of this study is to confirm the safety and efficacy of the RenzanTM Peripheral Stent System when used for treatment of superficial femoral (SFA) and/or popliteal (POP) artery disease.

This trial plans to include 135 patients in (up to) 10 locations around in Europe.

Conditions

  • Superficial Femoral Artery Disease
  • Popliteal Artery Disease

Interventions

DEVICE

Stent implantation

Procedure can be conducted via either contralateral or antegrade approach. After a successful target lesion crossing, predilate the lesion using either plain old balloon angioplasty (POBA) or (if necessary) any available specialty balloon. The inflated diameter of the balloon should approximate the diameter of the vessel just distal to the lesion. Proper vessel preparation should achieve diameter of 1:1 to healthy vessel (with ≤20% residual stenosis, as per operator's assessment). Adjunctive debulking devices are prohibited. Final stent selection should be confirmed after a proper vessel preparation, considering the reference vessel diameter (RVD) for the optimal 1:1 stent-to-vessel sizing. The implanted dual layer length would encompass the entire lesion with the micromesh, covering it from healthy to healthy tissue. Post-dilatation of the stent for more optimal placement may be done at operator's discretion, using standard angioplasty with uncoated balloon.

Sponsors & Collaborators

  • Terumo Europe N.V.

    lead INDUSTRY

Principal Investigators

  • Koen Deloose, Dr · AZ Sint-Blasius Dendermonde

  • Torsten Fuss, Dr · Elblandhospital Radebeul

  • Michael Lichtenberg, Dr · Karolinen-Hospital: Klinikum Arnsberg

  • Jérôme Brunet, Dr. · Clinique Rhône-Durance

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2024-06-24
Completion
2026-06-30

Countries

  • Belgium
  • France
  • Germany
  • Netherlands
  • Spain

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 NCT04546477 on ClinicalTrials.gov