Clinical trial NCT04562740: ABLUMINUS DES BTK Registry - FIM
Official title: ABLUMINUS Below the Knee (BTK) Drug Eluting Stent (DES) Registry (ABLUMINUS BTK) - First in Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease
Arterial Disease of Legs
Atherosclerosis
Keywords: Sirolimus
DES
PAD
PTA
Lead sponsor: Concept Medical Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: During the index angioplasty revascularisation procedure of the limb salvage programme, the ABLUMINUS DES drug eluting stent will be deployed after successful conventional balloon angioplasty.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Subject is 21 years or older and has signed and dated the trial informed consent document (ICD)
2. Subject is willing and able to comply with the trial testing, procedures and follow-up schedule
3. 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
4. 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

1. Occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies).
2. Target lesion(s) must be at least 4cm above the ankle joint
3. Degree of stenosis ≥ 70% by visual angiographic assessment
4. RVD is between 2.5 - 3.75mm
5. Total target lesion length (or series of lesion segments) to be treated is \> 200 mm
6. Target lesion(s) is located in an area that may be stented without blocking access to patent main branches
7. Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion
8. Guidewire has successfully crossed the target lesion(s)

Exclusion Criteria:

1. Life expectancy ≤ 1year
2. Stroke ≤ 90 days prior to the procedure date
3. Prior or planned major amputation in the target limb
4. Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass)
5. Previously implanted stent in the target vessel(s)
6. Failed PTA of target lesion/vessel ≤ 60 days prior to the procedure date
7. Heel gangrene
8. Subject has a platelet count ≤ 50 or ≥ 600 X 103/µL ≤ 30 days prior to the procedure date
9. NYHA class IV heart failure
10. Subject has symptomatic coronary artery disease (ie, unstable angina)
11. History of myocardial infarction or thrombolysis ≤ 90 days prior to the procedure date
12. Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger's disease, vasculitis)
13. Subject is currently taking Canagliflozin
14. Body Mass Index (BMI) \<18
15. Active septicemia or bacteremia
16. Coagulation disorder, including hypercoagulability
17. Contraindication to anticoagulation or antiplatelet therapy
18. Known allergies to stent or stent components
19. Known allergy to contrast media that cannot be adequately pre-medicated prior to the interventional procedure
20. Known hypersensitivity to heparin
21. Subject is on a high dose of steroids or is on immunosuppressive therapy
22. 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)

Intraoperative exclusion criteria

1. Angiographic evidence of intra-arterial acute/subacute thrombus or presence of atheroembolism
2. Treatment required in \> 2 target vessels (Note: a target lesion originating in one vessel and extending into another vessel is considered 1 target vessel)
3. Treatment requires the use of alternate therapy in the target vessel(s)/lesion(s), (eg, atherectomy, cutting balloon, re-entry devices, laser, radiation therapy)
4. Aneurysm is present in the target vessel(s)
5. Extremely calcified lesions
6. Failure to obtain \<30% residual stenosis in a pre-existing lesion

Primary outcomes:
measure: Primary patency using duplex ultrasound at 6 months post-procedure
timeFrame: at 6 months post-procedure
measure: Major adverse events (MAE) at 6 months post-procedure
timeFrame: at 6 months post-procedure
Secondary outcomes:
measure: Primary and assisted primary patency
timeFrame: 6, 12, 24 months post procedure
measure: Clinically driven target lesion revascularization
timeFrame: 1, 3, 6, 12, 24 months post procedure
measure: Major amputation rates
timeFrame: 1, 3, 6, 12, 24 months post procedure
measure: Subject quality-of-life values by change in EQ-5D (EuroQol 5 dimension)
timeFrame: 1, 3, 6 and 12 months post procedure
measure: Wound Assessment
timeFrame: 1, 3, 6, 12, 24 months post procedure
measure: Rutherford classification
timeFrame: 3, 6, 12, 24 months post procedure
measure: Adverse Events
timeFrame: 1, 3, 6, 12, 24 months post procedure
measure: Unplanned hospital readmission
timeFrame: Up to 30 days post procedure
measure: All Cause Mortality
timeFrame: 6, 12, 24 months years post procedure
measure: Hemodynamic outcomes
timeFrame: 6 and 12 months post procedure
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Sengkang General Hospital
Study officials:
References:
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citation: Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, Schmidt A, Tessarek J, Vinck E, Schwartz LB. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14.
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