Investigating the Safety and Efficacy of the Treatment With the Non-compliant Jade Balloon in TAS… (NCT04534192) | Clinical Trial Compass
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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
Singapore50 participantsStarted 2020-08-01
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. Age of subject is \> 40 years old. Patient covered by MediShield insurance as provided by Singapore government.
✓. Patient has critical limb ischemia, presenting a score from 4 to 6 following the Rutherford classification
✓. Patients must agree to return for all required post-index procedure follow-up visits.
✓. Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
✓. Patient has a projected life expectancy of at least 12 months and has not suffered a myocardial infarction within past 30 days
✓. De novo and post-PTA re-stenotic lesions located in the superficial femoral, popliteal and tibial arteries suitable for endovascular therapy
✓. The target lesion is located within the native SFA/popliteal/tibial artery
✓. The length of the target lesion(s) is \> 100mm and considered as TASC C or D lesion according to the TASC II classification.
Exclusion criteria
✕. Patient is permanently wheel-chair bound or bedridden
✕. Presence of a stent in the target lesion(s) that was placed during a previous procedure
✕. The intervention is being performed in preparation for a planned amputation.