Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter. — KANSHAS-1  

Peripheral Artery Disease Clinical Trial

Official title: Prospective, Multi-Center, Open, Single Arm Study for the Treatment of Patients Presenting De Novo Lesions in the Superficial Femoral and/or Popliteal Arteries Using a Kanshas Drug Coated Balloon Catheter.

Status Completed

Clinical Trial Summary

Assessing the safety and effectiveness of the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral (SFA) and/or popliteal arteries.

Clinical Trial Description

The KANSHAS 1 (K-1) trial investigates the inhibition of restenosis using the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral and/or popliteal arteries.

This clinical study is a prospective, multi-center, open, single-arm study. Up to 50 patients will be enrolled at 2 sites in Belgium and 4 sites in Germany. Follow-ups are scheduled before discharge, at 1 month (Clinic Visit or Phone FU), 6 months, 1-year, 2-years (Clinic Visits), 3-, 4- and 5- years (Clinic Visits or Phone FU).

Primary outcome measure:

• freedom from device-and procedure-related death through 30 days.

• freedom from target limb amputations and clinically driven target lesion revascularization through 6 months. ;

Related Conditions & MeSH terms

• Femoropopliteal Occlusive Disease
• Peripheral Arterial Disease
• Peripheral Artery Disease

• NCT number: NCT02939924
• Study type: Interventional
• Source: Terumo Europe N.V.
• Status: Completed
• Phase: N/A
• Start date: April 7, 2017
• Completion date: March 29, 2023