Extensive arterial occlusion significantly reduces arterial perfusion, and may eventually lead to Critical Limb Ischemia (CLI). The pathology gives rise to symptoms such as ischemic pain, slow healing wounds at lower extremity and gangrene. It places patients with multi-segment occlusion at high risks of amputations and mortality. The treatment methods for such long occlusive lesions are limited. Traditionally, the standard of care would be surgical revascularization. This is because lesion length have been identified in several studies as an independent risk factor for the development of restenosis after angioplasty and/or stenting. However, thanks to recent advances in endovascular techniques, such as the utilization of subintimal technique for crossing long segment occlusions, it is now possible to employ endovascular techniques for suitable patients.The re-establishment of an in-line flow, even if only temporary, can allow tissue healing, which is vital in achieving limb salvage. In addition, the use of Drug Coated Balloons (DCB) can potentially reduce restenosis rate, as Sirolimus have an anti-proliferative effect. To date, there are few studies that have evaluated the performance of DCB in lesions that are longer than 10cm. The investigators hope to evaluate the performance of the Selution DCB when used in treatment of such lesions
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Suitable lesions will be treated with SELUTION Sirolimus DCB
Singapore General Hospital
Singapore, Singapore
Freedom from Major Adverse Events
Composite of freedom from device- and procedure-related mortality
Time frame: 30 days post-index procedure
Freedom from clinically driven target lesion revascularization
Any re-intervention performed for more than 50% diameter stenosis at target lesion after documentation of recurrent or unresolved and continuing clinical symptoms
Time frame: 6 months post-index procedure
Primary patency
Absence of hemodynamically significant stenosis on duplex ultrasound at target lesion and without target lesion revascularization between time of procedure and the given follow-up
Time frame: 6 and 12 months post-index procedure
Technical Success
Ability to cross and dilate the lesions and achieve residual angiographic stenos no greater than 30%
Time frame: Immediately post-op
Freedom from clinically-drive target lesion revascularization
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 respective time points
Time frame: 12 month post-index procedure
Clinical success at follow-up
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
Time frame: 6 and 12 months post-index procedure
Freedom from Serious Adverse Events
Time frame: 1 year post-index procedure
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