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

Peripheral Arterial Disease (PAD) Clinical Trial

Official title:
ULTRASCORE™ Focused Force PTA Balloon Angioplasty for CLI Patients With Below the Knee Vessel Disease- a Multi-center Experience in 80 Subsequent Patients

Clinical Trial 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.

Clinical Trial Description

This single-arm, prospective, multi-center CE marked study (IIT) is planned to include up to 80 subjects with CLI in below the knee vessels with de novo stenoses or non-stented re-stenotic in total greater or equal 70% stenosis or occlusion of lower limb lesion. During the index procedure at Day 1 patients will be treated with ULTRASCORE™ Focused Force balloon. Follow-up investigations for evaluation of parameters for primary and secondary endpoints will be performed at 4 weeks, 6 months, and 12 months after the index procedure.. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04631848
Study type Observational
Source Klinikum Arnsberg
Contact
Status Recruiting
Phase
Start date October 23, 2020
Completion date May 2023
View Details
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