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AndraTec PMCF Study : Investigating the AndraTec Guidewires,PTA Balloons and Stents in Iliac Disease.

NCT04822727 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-08-23

No results posted yet for this study

Summary

This PMCF study is designed as prospective, multi-center study to collect real-life data.

The rationale of this study is to confirm and support the clinical safety and performance of the aforementioned products in 200 patients who will undergo an endovascular intervention within standard-of-care (SOC) where at least 1 of the following devices from AndraTec were used:

The LOKUM-Quest guidewire, The LOKUM AMPLATZ guidewire, the Slider Hydrophilic Nitinol Guidewire, the AltoSa-XL PTA balloon, the AltoSa-XL GEMINI PTA Balloon, the OPTIMUS CoCr Stent , the OPTIMUS-CVS PTFE-Covered stent.

Conditions

Interventions

DEVICE

1 or more AndraTec devices (see description for list of devices)

1 or more AndraTec devices (Lokum L-Quest guidewire, Lokum Amplatz guidewire, Slider Hydrophilic Nitinol Guidewire, AltoSa-XL PTA Balloon, Alto-Sa-XL Gemini Balloon, Optimus-CoCr stent, Optimus-CVS PTFE covered stent)

Sponsors & Collaborators

  • Dr. Sabrina Overhagen

    lead OTHER

Principal Investigators

  • Giovanni Torsello, Prof. MD. · Foundation for Cardiovascular Research and Education

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2022-12-31
Completion
2023-12-31

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Entities

Diseases

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 NCT04822727 on ClinicalTrials.gov