First-in-human Evaluation of the SELUTION DCB, a Novel Sirolimus Coated Balloon in Peripheral Arteries

Patients With Peripheral Artery Disease in the SFA or PA Clinical Trial

Official title: SELUTION™ Sirolimus Coated PTA Balloon Catheter Prospective, Controlled, Multi-Center, Open, Single-Arm Clinical Investigation for the Treatment of Patients With Femoropopliteal Artery Lesions With a Novel Drug Coated Balloon

Status Completed

Clinical Trial Summary

The primary objective of the Clinical Investigation is to assess the clinical safety and the inhibition of restenosis of the Investigational Device in the treatment of de-novo occluded/stenotic or re-occluded/restenotic lesions of the superficial femoral and/or popliteal arteries.

The primary endpoint of the Clinical Investigation is Late Lumen Loss (LLL) of the target lesion, as measured by Quantitative Vascular Angiography (QVA) at 6 months post-index procedure.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Patients With Peripheral Artery Disease in the SFA or PA
• Peripheral Arterial Disease

• NCT number: NCT02941224
• Study type: Interventional
• Source: M.A. Med Alliance S.A.
• Status: Completed
• Phase: Phase 1
• Start date: October 2016
• Completion date: September 2019