ABLUMINUS DES BTK Registry - FIM

  • STATUS
    Recruiting
  • End date
    Dec 2, 2023
  • participants needed
    30
  • sponsor
    Concept Medical Inc.
Updated on 14 June 2022
stenosis
ischemia
stenotic

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.

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.

Details
Condition Peripheral Artery Disease, Arterial Disease of Legs, Atherosclerosis
Treatment ABLUMINUS DES drug eluting stent
Clinical Study IdentifierNCT04562740
SponsorConcept Medical Inc.
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is 21 years or older and has signed and dated the trial informed consent document (ICD)
Subject is willing and able to comply with the trial testing, procedures and follow-up schedule
Subject has chronic, symptomatic diabetic related lower limb ischemia, determined by Rutherford categories 4 to 6 in the target limb, with wound(s) confined to toes/forefoot
Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator
Intraoperative inclusion criteria
Occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies)
Target lesion(s) must be at least 4cm above the ankle joint
Total target lesion length (or series of lesion segments) to be treated is > 200 mm
Degree of stenosis ≥ 70% by visual angiographic assessment
Target lesion(s) is located in an area that may be stented without blocking access to patent main branches
RVD is between 2.5 - 3.75mm
Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion
Guidewire has successfully crossed the target lesion(s)

Exclusion Criteria

Life expectancy ≤ 1year
Subject has a platelet count ≤ 50 or ≥ 600 X 103/µL ≤ 30 days prior to the procedure date
Stroke ≤ 90 days prior to the procedure date
Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger's disease, vasculitis)
Prior or planned major amputation in the target limb
Failed PTA of target lesion/vessel ≤ 60 days prior to the procedure date
Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass)
Previously implanted stent in the target vessel(s)
Heel gangrene
NYHA class IV heart failure
History of myocardial infarction or thrombolysis ≤ 90 days prior to the procedure date
Known allergy to contrast media that cannot be adequately pre-medicated prior to the interventional procedure
Subject has symptomatic coronary artery disease (ie, unstable angina)
Subject is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the Concept Medical study team)
Subject is currently taking Canagliflozin
Body Mass Index (BMI) <18
Angiographic evidence of intra-arterial acute/subacute thrombus or presence of atheroembolism
Active septicemia or bacteremia
Treatment required in > 2 target vessels (Note: a target lesion originating in one vessel and extending into another vessel is considered 1 target vessel)
Coagulation disorder, including hypercoagulability
Treatment requires the use of alternate therapy in the target vessel(s)/lesion(s), (eg, atherectomy, cutting balloon, re-entry devices, laser, radiation therapy)
Contraindication to anticoagulation or antiplatelet therapy
Known allergies to stent or stent components
Known hypersensitivity to heparin
Subject is on a high dose of steroids or is on immunosuppressive therapy
Intraoperative exclusion criteria
Aneurysm is present in the target vessel(s)
Extremely calcified lesions
Failure to obtain <30% residual stenosis in a pre-existing lesion
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