ABLUMINUS DES BTK Registry - FIM

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04562740
• Other study ID #: ABLUMINUS BTK
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: December 2, 2024

Study information

• Verified date: August 2023
• Source: Concept Medical Inc.
• Contact: Edward Choke
• Phone: 65 69302164
• Email: edward.choke.t.c[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Disease of Legs
• Atherosclerosis
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• ABLUMINUS DES drug eluting stent
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.

Locations

Country	Name	City	State
Singapore	Sengkang General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Concept Medical Inc.

Country where clinical trial is conducted

Singapore, 

References & Publications (7)

Biondi-Zoccai GG, Sangiorgi G, Lotrionte M, Feiring A, Commeau P, Fusaro M, Agostoni P, Bosiers M, Peregrin J, Rosales O, Cotroneo AR, Rand T, Sheiban I. Infragenicular stent implantation for below-the-knee atherosclerotic disease: clinical evidence from an international collaborative meta-analysis on 640 patients. J Endovasc Ther. 2009 Jun;16(3):251-60. doi: 10.1583/09-2691.1. — View 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. — View Citation

Kudo T, Chandra FA, Ahn SS. The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience. J Vasc Surg. 2005 Mar;41(3):423-35; discussion 435. doi: 10.1016/j.jvs.2004.11.041. — View Citation

Rastan A, Tepe G, Krankenberg H, Zahorsky R, Beschorner U, Noory E, Sixt S, Schwarz T, Brechtel K, Bohme C, Neumann FJ, Zeller T. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J. 2011 Sep;32(18):2274-81. doi: 10.1093/eurheartj/ehr144. Epub 2011 May 26. — View Citation

Romiti M, Albers M, Brochado-Neto FC, Durazzo AE, Pereira CA, De Luccia N. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg. 2008 May;47(5):975-981. doi: 10.1016/j.jvs.2008.01.005. Epub 2008 Apr 18. — View Citation

Scheinert D, Katsanos K, Zeller T, Koppensteiner R, Commeau P, Bosiers M, Krankenberg H, Baumgartner I, Siablis D, Lammer J, Van Ransbeeck M, Qureshi AC, Stoll HP; ACHILLES Investigators. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol. 2012 Dec 4;60(22):2290-5. doi: 10.1016/j.jacc.2012.08.989. — View Citation

Siablis D, Karnabatidis D, Katsanos K, Diamantopoulos A, Spiliopoulos S, Kagadis GC, Tsolakis J. Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia: analysis of long-term angiographic and clinical outcome. J Vasc Interv Radiol. 2009 Sep;20(9):1141-50. doi: 10.1016/j.jvir.2009.05.031. Epub 2009 Jul 19. — View Citation

Outcome

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