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Safety and Efficacy of the URECA CTO Device

Peripheral Vascular Disease Clinical Trial

Official title:
A Clinical Study Investigating the Safety and Efficacy of the URECA CTO Device

Clinical Trial Summary

Clinical study to investigate the safety and the efficacy of the URECA CTO Device during recanalization and mechanical re-entry into the true lumen after passing the occlusions/calcifications (chronic total occlusions) in the peripheral vasculature.

Clinical Trial Description

Peripheral Arterial Disease (PAD) restricts blood supply to the lower limbs. The disease causes obstructions that can affect blood vessels in both the proximal and distal regions. When these vessel obstructions exist for more than 3- 6 Months they are classed as chronic total occlusions. Without sufficient collateral formation this can lead to to chronic limb-treatening ischemia (CLTI), which is characterized by chronic pain and tissue loss. Without revascularization this frequently leads to amputation. The purpose of this clinical study is to investigate the safety and the efficacy of the URECA CTO Device during recanalization and mechanical re-entry into the true lumen after passing the occlusions/calcifications (chronic total occlusions) in the peripheral vasculature. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04385381
Study type Interventional
Source Ureca BV
Contact
Status Terminated
Phase N/A
Start date December 1, 2020
Completion date September 27, 2023
View Details
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