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.
Pulsatile straight line blood flow to the foot is required to aid wound healing in the setting of chronic limb threatening ischaemia (CLTI). Patients with CLTI usually present with infra-popliteal arterial occlusions and endovascular therapies to restore blood flow are often preferred considering their inherently less invasive nature and because of multiple patient background comorbidities or absence of a suitable vein conduit in these patients. Below The Knee (BTK) plain balloon angioplasty (POBA) remains the only viable "standard of care" in the management of long "Real World" BTK Lesions. However tibial angioplasty is plagued by high rate of re-occlusion/stenosis because of barotrauma caused by the intra-arterial ballooning and subsequent development of neointimal hyperplasia. Devices coated with paclitaxel have been used successfully to limit restenosis by inhibiting the biologic pathway that leads to intimal hyperplasia. However, a recent formal systematic review and study-level meta-analysis of randomized controlled trials investigating treatment of the infra-popliteal arteries with paclitaxel-coated balloons compared with conventional balloon angioplasty for critical limb ischemia (CLI) was recently published showing amputation-free survival was significantly worse in use of paclitaxel coated balloons compared to plain angioplasty. Furthermore current poor patency seen in BTK angioplasty is likely contributed in part by small vessel size and poor luminal gain after standard semi-compliant POBA. Vessel Preparation and Optimising POBA with High Pressure, Non-Compliant balloons may help achieve Luminal Gain for rapid and sustained flow for wound healing. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Suitable TASC C and D lesions will be treated with non-compliant high pressure JADE balloon.
Singapore General Hospital
Singapore, Singapore
RECRUITINGFreedom from Major Adverse Events
A composite of freedom from device- and procedure-related mortality through 30 days
Time frame: 30 days post-index procedure
Performance Primary Endpoint
Freedom from clinically driven target lesion revascularization (TLR) within 6 months post-index procedure. (Clinically driven TLR is defined as any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent or unresolved and continuing clinical symptoms of the patient.)
Time frame: 6 months post-index procedure
Primary patency rate
defined as absence of a hemodynamically significant stenosis on Duplex ultrasound (systolic velocity ratio no greater than 2.5) at the target lesion and without TLR within the time of procedure and the given follow-up. Note: Any patient where DUS is not analysable at index and/or at follow-up, where there is documented significant progression of disease above the target lesion, or who undergo a major amputation prior to the time of follow-up will be excluded from the calculation of this endpoint.
Time frame: 6- and 12-month post-index procedure
Technical success
defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%
Time frame: Immediately post-op
Freedom from clinically-driven TLR
defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge at the respective time points
Time frame: 12-month post-index procedure
Clinical success at follow-up
defined as an improvement of Rutherford classification at all follow- up time points of one class or more as compared to the pre-procedure Rutherford classification
Time frame: 6 and 12 months post index procedure
Wound healing
closure of primary wound by more than 70%
Time frame: 6 months post-index procedure
Freedom from major target limb amputation (above ankle)
Time frame: 6 months and 12 months post-index procedure
Improvements in walking
Comparison of the scores on the Walking Impairment Questionnaire (WIQ) between baseline and follow-ups.
Time frame: 3, 6 and 12 months post-index procedure.
Freedom from serious adverse events
as defined per ISO 14155:2011
Time frame: 3, 6 and 12 months post-index procedure.
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