NCT04631848

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Michael Lichtenberg, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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..

Conditions

• Peripheral Arterial Disease (PAD)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-10-23
• Primary completion: 2022-12-01
• Completion: 2023-05-01
• First posted: 2020-11-17
• Last updated: 2022-03-31

Locations

1 site across 1 country: Germany