Last updated on February 2018

Treatment of Patients With Lesions in the Superficial Femoral or Popliteal Arteries Using Kanshas Drug Coated Balloon


Brief description of study

To assess safety and efficacy of the Kanshas DCB in the treatment of de novo lesions in the superficial femoral (SFA) and/or popliteal arteries.

Detailed Study Description

The KANSHAS 1 (K-1) trial investigates the inhibition of restenosis using the Kanshas DCB in the treatment of de novo lesions in the superficial femoral or popliteal arteries.

The proposed clinical study will be a prospective, multi-center, controlled, open, single-arm study. Up to 50 patients will be enrolled at up to 7 sites in Belgium and Germany. Follow-ups are scheduled before discharge, at 30 days, 6 months, 1, and 2 years. Each patient will have a follow-up contact via hospital visit and telephone.

Clinical Study Identifier: NCT02939924

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Koen Deloose

AZ Sint Blasius
Dendermonde, Belgium
4.39miles
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