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ABLUMINUS DES BTK Registry - FIM

Atherosclerosis Clinical Trial

Official title:
ABLUMINUS Below the Knee (BTK) Drug Eluting Stent (DES) Registry (ABLUMINUS BTK) - First in Men

Clinical Trial Summary

A prospective, single center, single arm non-randomized trial collecting safety and effectiveness data for the ABLUMINUS DES System to treat BTK lesions in subjects with CLI.

Clinical Trial Description

The burden of limb loss as a result of peripheral arterial disease (PAD) is high and this problem is set to worsen globally with increasing prevalence of diabetes. Treatment of PAD in diabetic critical limb ischemia (CLI) primarily involves revascularisation of the limb. Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by most vascular centers. Arterial blockages for diabetic CLI patients occur predominantly in below the knee arteries which can be challenging to treat effectively. This is due to the high incidence of arterial recoil after conventional balloon angioplasty due the natural tendency of the vessels to maintain their original shape and the high restenosis rates of calcified lesions. To address these problems the novel ABLUMINUS DES system is specifically designed to withstand the mechanical recoil of diseased BTK arteries whilst delivering sirolimus to biologically inhibit restenosis. This study postulates that the application of the ABLUMINUS DES system will be safe and will result in better vascular patency in BTK arteries for CLI patients. The investigators aim to conduct a prospective, all comers, single arm, single centre registry of the ABLUMINUS DES system for the treatment of BTK disease. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04562740
Study type Interventional
Source Concept Medical Inc.
Contact Edward Choke
Phone 65 69302164
Email edward.choke.t.c@singhealth.com.sg
Status Recruiting
Phase N/A
Start date August 20, 2020
Completion date December 2, 2024
View Details
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