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ULTRASCORE™ Focused Force PTA Balloon Angioplasty for CLI Patients With Below the Knee Vessel Disease

NCT04631848 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2022-03-31

No results posted yet for this study

Summary

The purpose of this single-arm, exploratory study is to evaluate safety and performance of treatment of critical limb ischemia (CLI) with the ULTRASCORE™ Focused Force balloon.

Patients with CLI in below the knee vessels will receive a percutaneous transluminal angioplasty with the device and will be followed up for 12 months.

Conditions

  • Peripheral Arterial Disease (PAD)

Interventions

DEVICE

ULTRASCORE™ Focused Force PTA Balloon

The device will be used for percutaneous transluminal angioplasty (PTA) to dilatate calcified stenoses in below the knee vessels

Sponsors & Collaborators

  • Michael Lichtenberg, MD

    lead OTHER

Principal Investigators

  • Michael Lichtenberg, Dr. med. · Klinikum Hochsauerland GmbH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-23
Primary Completion
2022-12-31
Completion
2023-05-31

Countries

  • Germany

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 NCT04631848 on ClinicalTrials.gov