ABLUMINUS DES BTK Registry - FIM

NCT04562740 | Unknown DMC

• 1 other identifier: ABLUMINUS BTK
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease; Arterial Disease of Legs; Atherosclerosis

Keywords

Sirolimus; DES; PAD; PTA

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (10)

• Primary and assisted primary patency

  6, 12, 24 months post procedure

• Clinically driven target lesion revascularization

  1, 3, 6, 12, 24 months post procedure

• Major amputation rates

  1, 3, 6, 12, 24 months post procedure

• Subject quality-of-life values by change in EQ-5D (EuroQol 5 dimension)

  1, 3, 6 and 12 months post procedure

• Wound Assessment

  1, 3, 6, 12, 24 months post procedure

Study Arms (1)

ABLUMINUS DES

EXPERIMENTAL

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

ABLUMINUS DES drug eluting stent DEVICE

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.

ABLUMINUS DES

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 21 years or older and has signed and dated the trial informed consent document (ICD)
• Subject is willing and able to comply with the trial testing, procedures and follow-up schedule
• 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
• 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
• Occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies).
• Target lesion(s) must be at least 4cm above the ankle joint
• Degree of stenosis ≥ 70% by visual angiographic assessment
• RVD is between 2.5 - 3.75mm
• Total target lesion length (or series of lesion segments) to be treated is \> 200 mm
• Target lesion(s) is located in an area that may be stented without blocking access to patent main branches
• Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion
• Guidewire has successfully crossed the target lesion(s)

You may not qualify if:

• Life expectancy ≤ 1year
• Stroke ≤ 90 days prior to the procedure date
• Prior or planned major amputation in the target limb
• Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass)
• Previously implanted stent in the target vessel(s)
• Failed PTA of target lesion/vessel ≤ 60 days prior to the procedure date
• Heel gangrene
• Subject has a platelet count ≤ 50 or ≥ 600 X 103/µL ≤ 30 days prior to the procedure date
• NYHA class IV heart failure
• Subject has symptomatic coronary artery disease (ie, unstable angina)
• History of myocardial infarction or thrombolysis ≤ 90 days prior to the procedure date
• Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger's disease, vasculitis)
• Subject is currently taking Canagliflozin
• Body Mass Index (BMI) \<18
• Active septicemia or bacteremia

Sponsors & Collaborators

• Concept Medical Inc.: lead

Study Sites (1)

Sengkang General Hospital

Singapore, 544886, Singapore

RECRUITING

Related Publications (7)

• 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.

  PMID: 18372148 BACKGROUND

• 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.

  PMID: 19620014 BACKGROUND

• 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.

  PMID: 19642789 BACKGROUND

• 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.

  PMID: 15838475 BACKGROUND

• 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.

  PMID: 23194941 BACKGROUND

• 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.

  PMID: 22169682 BACKGROUND

• 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.

  PMID: 21622669 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Edward Choke

CONTACT

65 69302164; edward.choke.t.c@singhealth.com.sg

Edward Choke

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: August 20, 2020
• Primary Completion: June 1, 2024
• Study Completion: December 2, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

SG (1)