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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.

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02939924
Study type Interventional
Source Terumo Europe N.V.
Contact
Status Completed
Phase N/A
Start date April 7, 2017
Completion date March 29, 2023
View Details
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