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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Following successful plain balloon angioplasty of the arterial lesion, (defined as \<30% residual stenosis after treatment at rated burst pressure of the angioplasty balloon), the ABLUMINUS stent will be deployed at the lesion as per Instructions for Use (IFU) after appropriate sizing using the diameter of the plain balloon angioplasty. After deployment of the ABLUMINUS stent, further balloon angioplasty of the stent will be performed, using the same diameter standard balloon catheter at 2 minutes inflation, to ensure adequate moulding and expansion of the stent.
Sengkang General Hospital
Singapore, Singapore
RECRUITINGPrimary patency using duplex ultrasound at 6 months post-procedure
Number of Primary patency using duplex ultrasound at 6 months post-procedure
Time frame: at 6 months post-procedure
Major adverse events (MAE) at 6 months post-procedure
Number of Major adverse events (MAE) (MAE is defined as above ankle amputation in index limb; major re-intervention; and perioperative (30 day) mortality)
Time frame: at 6 months post-procedure
Primary and assisted primary patency
Target lesion patency rate measured by duplex ultrasound
Time frame: 6, 12, 24 months post procedure
Clinically driven target lesion revascularization
Number of Clinically-driven target lesion revascularization
Time frame: 1, 3, 6, 12, 24 months post procedure
Major amputation rates
Rates of amputation of the lower limb at the ankle level or above
Time frame: 1, 3, 6, 12, 24 months post procedure
Subject quality-of-life values by change in EQ-5D (EuroQol 5 dimension)
The EQ-5D is a descriptive system of health-related quality-of-life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 5 responses. The responses record 5 levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension). The levels are assigned a numeric code 1-5 (eg, 1= no problems and 5= extreme problems). Sub-scores are not applicable.
Time frame: 1, 3, 6 and 12 months post procedure
Edward Choke
CONTACT
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Wound Assessment
Descriptive characteristics of wound healing will be recorded
Time frame: 1, 3, 6, 12, 24 months post procedure
Rutherford classification
Change in Rutherford classification as assessed by the investigator
Time frame: 3, 6, 12, 24 months post procedure
Adverse Events
Number of Adverse events
Time frame: 1, 3, 6, 12, 24 months post procedure
Unplanned hospital readmission
Unplanned hospital related to Critical Limb Ischemia readmission rate
Time frame: Up to 30 days post procedure
All Cause Mortality
Number of patients with all-cause death
Time frame: 6, 12, 24 months years post procedure
Hemodynamic outcomes
Changes in ankle brachial index (ABI) and/or Toe pressures (TP
Time frame: 6 and 12 months post procedure