The objective of this clinical investigation is to evaluate the 6-month outcome of the Selution Sirolimus-coated Balloon for the treatment of long tibial occlusive disease (TASC C and D) in patients with Critical Limb Ischemia (CLI)
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 bee 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) and Drug Eluting Stents (DES) can potentially reduce restenosis rate. To date, there are few studies that have evaluated the performance of DCB in lesions that are longer than 10cm. We 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
25
SELUTION DCB will be used during lower limb angioplasty for treatment of lesions that are TASC C and D, in patients with Critical Limb Ischemia
Singapore General Hospital
Singapore, Singapore
Clinical Primary Safety Endpoint
Defined as freedom from Major Adverse Event (MAE) - A composite of freedom from device- and procedure-related mortality
Time frame: 30 Days
Performance Primary Endpoint
Defined as 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
Primary Patency Rates
Primary patency 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 target lesion revascularization within the time of procedure and the given follow-up.
Time frame: 12 Months
Technical Success
Defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%
Time frame: Intra-operative
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
Clinical success at follow-up
Defined as an improvement of Rutherford Classification at all follow-up time points of once class or more as compared to the pre-procedure Rutherford Classification
Time frame: 12 months
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Wound healing
Defined as closure of primary wound by more than 70% at 6 months or complete healing of primary closed wounds
Time frame: 6 months
Freedom from Major Target Limb Amputation
Time frame: 12 months
Freedom from Severe Adverse Events
Time frame: 12 months