ABLUMINUS DES BTK Registry - FIM

Not Applicable

Recruiting

• Conditions: Peripheral Artery Disease; Arterial Disease of Legs; Atherosclerosis
• Interventions: Device: ABLUMINUS DES drug eluting stent

• Registration Number: NCT04562740
• Lead Sponsor: Concept Medical Inc.

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.

Study Timeline

• Study Start: 2020-08-20
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-18
• Study First Posted: 2020-09-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-29
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABLUMINUS DES	ABLUMINUS DES drug eluting stent	ABLUMINUS DES drug eluting stent will be deployed after successful conventional balloon angioplasty. Sirolimus drug dosage on the ABLUMINUS DES drug eluting stent system is determined by Concept Medical to deliver the optimal dose of sirolimus to the abluminal surface of the BTK lesions.

Primary Outcome Measures

Name	Time	Method
Primary patency using duplex ultrasound at 6 months post-procedure	at 6 months post-procedure	Number of Primary patency using duplex ultrasound at 6 months post-procedure
Major adverse events (MAE) at 6 months post-procedure	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)

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1, 3, 6, 12, 24 months post procedure	Number of Adverse events
Rutherford classification	3, 6, 12, 24 months post procedure	Change in Rutherford classification as assessed by the investigator
Hemodynamic outcomes	6 and 12 months post procedure	Changes in ankle brachial index (ABI) and/or Toe pressures (TP
Major amputation rates	1, 3, 6, 12, 24 months post procedure	Rates of amputation of the lower limb at the ankle level or above
Unplanned hospital readmission	Up to 30 days post procedure	Unplanned hospital related to Critical Limb Ischemia readmission rate
Primary and assisted primary patency	6, 12, 24 months post procedure	Target lesion patency rate measured by duplex ultrasound
All Cause Mortality	6, 12, 24 months years post procedure	Number of patients with all-cause death
Clinically driven target lesion revascularization	1, 3, 6, 12, 24 months post procedure	Number of Clinically-driven target lesion revascularization
Wound Assessment	1, 3, 6, 12, 24 months post procedure	Descriptive characteristics of wound healing will be recorded
Subject quality-of-life values by change in EQ-5D (EuroQol 5 dimension)	1, 3, 6 and 12 months post procedure	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.

Trial Locations

Locations (1)

Sengkang General Hospital; 🇸🇬 Singapore, Singapore