- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04562740
ABLUMINUS DES BTK Registry - FIM
ABLUMINUS Below the Knee (BTK) Drug Eluting Stent (DES) Registry (ABLUMINUS BTK) - First in Men
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Edward Choke
Study Contact Backup
- Name: Edward Choke
- Phone Number: 65 69302164
- Email: edward.choke.t.c@singhealth.com.sg
Study Locations
-
-
-
Singapore, Singapore, 544886
- Recruiting
- Sengkang General Hospital
-
Contact:
- Edward Choke, Dr
- Email: edward.choke.t.c@singhealth.com.sg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Intraoperative inclusion criteria
- 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)
Exclusion Criteria:
- 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
- Coagulation disorder, including hypercoagulability
- Contraindication to anticoagulation or antiplatelet therapy
- Known allergies to stent or stent components
- Known allergy to contrast media that cannot be adequately pre-medicated prior to the interventional procedure
- Known hypersensitivity to heparin
- Subject is on a high dose of steroids or is on immunosuppressive therapy
- 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
- Angiographic evidence of intra-arterial acute/subacute thrombus or presence of atheroembolism
- Treatment required in > 2 target vessels (Note: a target lesion originating in one vessel and extending into another vessel is considered 1 target vessel)
- Treatment requires the use of alternate therapy in the target vessel(s)/lesion(s), (eg, atherectomy, cutting balloon, re-entry devices, laser, radiation therapy)
- Aneurysm is present in the target vessel(s)
- Extremely calcified lesions
- Failure to obtain <30% residual stenosis in a pre-existing lesion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary patency using duplex ultrasound at 6 months post-procedure
Time Frame: 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
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject quality-of-life values by change in EQ-5D (EuroQol 5 dimension)
Time Frame: 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.
|
1, 3, 6 and 12 months post procedure
|
Primary and assisted primary patency
Time Frame: 6, 12, 24 months post procedure
|
Target lesion patency rate measured by duplex ultrasound
|
6, 12, 24 months post procedure
|
Clinically driven target lesion revascularization
Time Frame: 1, 3, 6, 12, 24 months post procedure
|
Number of Clinically-driven target lesion revascularization
|
1, 3, 6, 12, 24 months post procedure
|
Major amputation rates
Time Frame: 1, 3, 6, 12, 24 months post procedure
|
Rates of amputation of the lower limb at the ankle level or above
|
1, 3, 6, 12, 24 months post procedure
|
Wound Assessment
Time Frame: 1, 3, 6, 12, 24 months post procedure
|
Descriptive characteristics of wound healing will be recorded
|
1, 3, 6, 12, 24 months post procedure
|
Rutherford classification
Time Frame: 3, 6, 12, 24 months post procedure
|
Change in Rutherford classification as assessed by the investigator
|
3, 6, 12, 24 months post procedure
|
Adverse Events
Time Frame: 1, 3, 6, 12, 24 months post procedure
|
Number of Adverse events
|
1, 3, 6, 12, 24 months post procedure
|
Unplanned hospital readmission
Time Frame: Up to 30 days post procedure
|
Unplanned hospital related to Critical Limb Ischemia readmission rate
|
Up to 30 days post procedure
|
All Cause Mortality
Time Frame: 6, 12, 24 months years post procedure
|
Number of patients with all-cause death
|
6, 12, 24 months years post procedure
|
Hemodynamic outcomes
Time Frame: 6 and 12 months post procedure
|
Changes in ankle brachial index (ABI) and/or Toe pressures (TP
|
6 and 12 months post procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABLUMINUS BTK
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atherosclerosis
-
University Hospital, CaenUnknownPeripheral Arterial Disease | Atherosclerosis Obliterans | Atherosclerosis Right Leg | Atherosclerosis Left LegFrance
-
Nantes University HospitalAbbottCompletedAtherosclerosis ObliteransFrance
-
Central Hospital, Nancy, FranceSuspended
-
Federal University of São PauloCompletedAtherosclerosis of ArteryBrazil
-
MedtronicActive, not recruitingAtherosclerosis of Femoral Artery | Obstructive Disease | Atherosclerosis of Popliteal ArteryFrance
-
Cabinet de Medecine Interne Générale Demetrio PitarchCompletedAtherosclerosis of Artery
-
Emory UniversityThe Robert W. Woodruff FoundationCompleted
-
Korea UniversityMinistry of Health & Welfare, KoreaCompletedAtherosclerosis | Noninvasive Imaging of AtherosclerosisKorea, Republic of
-
Zhejiang Zylox Medical Device Co., Ltd.RecruitingAtherosclerosis of Femoral ArteryGermany
-
VA Office of Research and DevelopmentCompletedSaphenous Vein Graft AtherosclerosisUnited States
Clinical Trials on ABLUMINUS DES drug eluting stent
-
Biotronik FranceUnknown
-
Papworth Hospital NHS Foundation TrustCompletedMyocardial Ischemia | Angina, Stable | CHD - Coronary Heart DiseaseUnited Kingdom
-
Aarhus University Hospital SkejbyOdense University Hospital; University of Copenhagen; University of AarhusCompletedCoronary Artery Disease | Angina Pectoris
-
Catholic University of the Sacred HeartCompletedSaphenous Vein Graft Disease
-
Medtronic VascularCompleted
-
Chinese PLA General HospitalUnknown
-
Seoul National University HospitalUnknownKor PCI - CAD Patients Treated With PCI: Analysis of the Korean Nationwide Health Insurance DatabaseCoronary Artery Disease | Drug-coated Balloon | Drug-eluting Stents
-
Instituto Dante Pazzanese de CardiologiaRecruitingPercutaneous Coronary Intervention | Myocardial Dysfunction | STEMI - ST Elevation Myocardial InfarctionBrazil
-
Poznan University of Medical SciencesCompleted
-
Shanghai MicroPort Medical (Group) Co., Ltd.Recruiting