The VaSecure BTK Study
NCT03638115 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2018-10-26
Summary
To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK)
Conditions
- Peripheral Artery Disease
- Peripheral Vascular Disease
- Peripheral Arterial Occlusive Disease
Interventions
- DEVICE
-
VaSecure™
Drug Coated PTA Balloon Catheter
Sponsors & Collaborators
-
Novella Clinical
collaborator OTHER -
Vascuros Medical Pte Ltd
lead INDUSTRY
Principal Investigators
-
Thomas Zeller, MD · Universitaets-Herzzentrum Freiburg - Bad Krozingen GmbH
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-30
- Primary Completion
- 2019-06-01
- Completion
- 2020-06-30
Countries
- Belgium
- Germany
- Singapore
Study Locations
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