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SOLARIS Peripheral PMCF Trial

NCT04299906 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-11-15

No results posted yet for this study

Summary

The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the Solaris Vascular Stent Graft (Scitech) in clinical settings when used according to the indications of the IFU.

Conditions

  • Peripheral Arterial Disease
  • Iliac Artery Stenosis
  • Common Femoral Artery Stenosis

Interventions

DEVICE

Solaris Vascular Stent Graft

Solaris Vascular Stent Graft for treatment of Iliac Lesions

Sponsors & Collaborators

  • FCRE (Foundation for Cardiovascular Research and Education)

    collaborator OTHER

  • Scitech Produtos Medicos Ltda

    collaborator INDUSTRY

  • Dr. Sabrina Overhagen

    lead OTHER

Principal Investigators

  • Michel Bosiers, MD · Insel Spital Bern

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2024-11-30
Completion
2024-12-30

Countries

  • Germany
  • Italy
  • Netherlands

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 NCT04299906 on ClinicalTrials.gov