Using a new drug-eluting stent to treat severe leg artery blockages in diabetic patients

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

This study is testing a new drug-coated stent to see if it can safely improve blood flow in the legs of diabetic patients with severe artery blockages.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Concept Medical Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Singapore)
• Trial ID: NCT04562740 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, single-center, single-arm registry aimed at collecting safety and effectiveness data for the ABLUMINUS DES system in treating below-the-knee (BTK) lesions in patients with critical limb ischemia (CLI) due to peripheral artery disease (PAD). The ABLUMINUS DES system is designed to prevent arterial recoil and reduce restenosis by delivering sirolimus directly to the affected area. The study will enroll patients who meet specific criteria, including chronic symptomatic diabetic-related lower limb ischemia, and will monitor their outcomes following the intervention. The goal is to demonstrate improved vascular patency and safety of this novel treatment approach.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 21 and older with chronic, symptomatic diabetic-related lower limb ischemia and specific arterial blockages.

Not a fit: Patients with non-diabetic related ischemia or those with lesions not meeting the study's inclusion criteria may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of limb loss in diabetic patients suffering from critical limb ischemia.

How similar studies have performed: While the use of drug-eluting stents in vascular interventions has shown promise, this specific application of the ABLUMINUS DES system is novel and has not been extensively tested in prior studies.

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

Where this trial is running

Singapore

• Sengkang General Hospital — Singapore, Singapore (Recruiting)

Study contacts

• Study coordinator: Edward Choke

Conditions Peripheral Artery Disease; Arterial Disease of Legs; Atherosclerosis; Sirolimus; DES; PAD; PTA