Investigating the Safety and Efficacy of the Treatment With the Non-compliant Jade Balloon in TASC C and D Athero-occlusive Infra-inguinal Disease in Patients With Chronic Limb Threatening Limb Ischemia From SingaporE
NCT04534192 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2020-11-02
Summary
The objective of this clinical study is to evaluate the 6-month safety and performance outcome of the non-compliant high pressure JADE balloon for the treatment of infrainguinal stenotic occlusive or stenotic TASC C \& D lesions in patients with chronic limb threatening ischemia.
Conditions
- Critical Limb Ischemia
- Peripheral Artery Disease
Interventions
- DEVICE
-
JADE Balloon
Suitable TASC C and D lesions will be treated with non-compliant high pressure JADE balloon.
Sponsors & Collaborators
-
National University Hospital, Singapore
collaborator OTHER -
Singapore General Hospital
lead OTHER
Principal Investigators
-
Tjun Yip Tang, MD · Singapore General Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-01
- Primary Completion
- 2022-03-01
- Completion
- 2022-08-01
Countries
- Singapore
Study Locations
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