This study aims to evaluate the 12 month outcome of the mono- or combination therapy with iVascular Luminor DCB and Angiolite DES for treatment of TASC C and TASC D long tibial occlusive disease, presenting with critical limb ischemia.
Extensive arterial occlusions significantly reduces distal 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) 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 iVascular Luminor DCB and Angiolite DES when used in the treatment of such lesions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Patient to undergo angioplasty with Luminor DCB and Angiolite DES
Singapore General Hospital
Singapore, Singapore
Khoo Teck Puat Hospital
Singapore, Singapore
Freedom from Major Adverse Events
No device- and procedure-related mortality through 30 days, no major target limb amputation.
Time frame: 30 days post-operation
Freedom from Target Lesion Revascularization
No re-intervention performed for more than 50% diameter stenosis at the target lesion after documentation of recurrent clinical symptoms of patient.
Time frame: 12 months post-operation
Primary patency rate
Absence of hemodynamically significant stenosis on duplex ultrasound (systolic velocity ration no greater than 2.5) at the target lesion and without TLR within the time of procedure and given follow-up
Time frame: 6 and 12 months post operation
Technical success
Ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%
Time frame: immediately post-operation
Freedom from clinically-driven TLR
Defined as absence of any repeat intervention to maintain and re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge
Time frame: 6 month follow-up
Clinical success at follow-up
Improvement of Rutherford Classification
Time frame: 1, 6 and 12 months post-operation
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