Treatment of Patients With Lesions in the Superficial Femoral or Popliteal Arteries Using Kanshas Drug Coated Balloon
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Femoropopliteal Occlusive Disease
- Peripheral Artery Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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, 2, 3, 4 and 5 years. Each patient will have a follow-up contact via hospital visit and telephone.
Tracking Information
- NCT #
- NCT02939924
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Michael Lichtenberg, MD Karolinen-Hospital Klinikum Arnsberg, Germany
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