Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critical Lower Limb Ischemia
- Sponsor
- Singapore General Hospital
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Freedom from Major Adverse Events
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patient refusing treatment
- •Patient is permanently wheel-chair bound or bedridden
- •Presence of a stent in the target lesion that was placed during a previous procedure
- •The intervention is being performed in preparation for a planned major amputation.
- •Untreated flow-limiting inflow lesions
- •Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
- •Previous bypass surgery in the same limb
- •Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- •Perforation at the angioplasty site evidenced by extravasation of contrast medium
- •Untreatable lesion located at the distal outflow arteries
Outcomes
Primary Outcomes
Freedom from Major Adverse Events
Time Frame: 30 days post-index procedure
Composite of freedom from device- and procedure-related mortality
Freedom from clinically driven target lesion revascularization
Time Frame: 6 months post-index procedure
Any re-intervention performed for more than 50% diameter stenosis at target lesion after documentation of recurrent or unresolved and continuing clinical symptoms
Secondary Outcomes
- Primary patency(6 and 12 months post-index procedure)
- Freedom from Serious Adverse Events(1 year post-index procedure)
- Wound healing(6 months post-index procedure)
- Freedom from major target limb amputation(6 and 12 months post-index procedure)
- Technical Success(Immediately post-op)
- Freedom from clinically-drive target lesion revascularization(12 month post-index procedure)
- Clinical success at follow-up(6 and 12 months post index procedure)