NCT02939924

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Terumo Europe N.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Femoropopliteal Occlusive Disease
• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Kanshas DCB	The appropriate Kanshas DCB size is selected after review of the patient's baseline angiogram and determination of the reference vessel diameter and lesion length. The balloons is sized to ensure the full length of the lesion is treated. The initial inflation of the study device should be approximately 1 minute for optimal drug release. In order to optimize lesion dilatation, longer inflation times are possible at the discretion of the operator.

Timeline

• Start date: 2017-04-07
• Primary completion: 2018-07-18
• Completion: 2023-03-29
• First posted: 2016-10-20
• Last updated: 2024-04-23

Locations

6 sites across 2 countries: Belgium, Germany