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RecruitingNCT04562740Updated Aug 29, 2023

ABLUMINUS DES BTK Registry - FIM

An interventional study of ABLUMINUS DES drug eluting stent in Peripheral Artery Disease, Arterial Disease of Legs and Atherosclerosis, sponsored by Concept Medical Inc.. Recruiting at 1 site in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-08-29.

Sponsored by Concept Medical Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Aug 2020; still recruiting 6 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Peripheral Artery Disease
  • Arterial Disease of Legs
  • Atherosclerosis

Keywords

  • Sirolimus
  • DES
  • PAD
  • PTA
03

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's planned enrollment of 30 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Concept Medical Inc. is the lead sponsor of 9 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    ABLUMINUS DES

    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.

    Device: ABLUMINUS DES drug eluting stent

Interventions

  • DeviceABLUMINUS 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.

06

What researchers measure

Primary outcomes

  1. Primary patency using duplex ultrasound at 6 months post-procedure

    Number of Primary patency using duplex ultrasound at 6 months post-procedure

    Time frame: at 6 months post-procedure

  2. 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)

    Time frame: at 6 months post-procedure

Secondary outcomes

  1. Primary and assisted primary patency

    Target lesion patency rate measured by duplex ultrasound

    Time frame: 6, 12, 24 months post procedure

  2. Clinically driven target lesion revascularization

    Number of Clinically-driven target lesion revascularization

    Time frame: 1, 3, 6, 12, 24 months post procedure

  3. Major amputation rates

    Rates of amputation of the lower limb at the ankle level or above

    Time frame: 1, 3, 6, 12, 24 months post procedure

  4. 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.

    Time frame: 1, 3, 6 and 12 months post procedure

  5. Wound Assessment

    Descriptive characteristics of wound healing will be recorded

    Time frame: 1, 3, 6, 12, 24 months post procedure

  6. Rutherford classification

    Change in Rutherford classification as assessed by the investigator

    Time frame: 3, 6, 12, 24 months post procedure

  7. Adverse Events

    Number of Adverse events

    Time frame: 1, 3, 6, 12, 24 months post procedure

  8. Unplanned hospital readmission

    Unplanned hospital related to Critical Limb Ischemia readmission rate

    Time frame: Up to 30 days post procedure

  9. All Cause Mortality

    Number of patients with all-cause death

    Time frame: 6, 12, 24 months years post procedure

  10. Hemodynamic outcomes

    Changes in ankle brachial index (ABI) and/or Toe pressures (TP

    Time frame: 6 and 12 months post procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 18372148 ↗
  • 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. PubMed 19620014 ↗
  • 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. PubMed 19642789 ↗
  • 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. PubMed 15838475 ↗
  • 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. PubMed 23194941 ↗
  • 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. PubMed 22169682 ↗
  • 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. PubMed 21622669 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04562740
Lead sponsor
Concept Medical Inc.
Responsible party
Sponsor
First posted
Sep 24, 2020
Start date
Aug 20, 2020
Primary completion
Jun 1, 2024 (estimated)
Completion
Dec 2, 2024 (estimated)
Last update
Aug 29, 2023

Study contacts

Edward Choke
Contact
edward.choke.t.c@singhealth.com.sg
65 69302164
Edward Choke
Contact

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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