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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04534192 on ClinicalTrials.gov