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DiabetesABILITYNCT04236609

Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global

A study testing Abluminus DES+ Sirolimus Eluting Stent System (SES) and XIENCE Everolimus Eluting Coronary Stent System (XIENCE family) in people with Diabetes and Coronary Artery Disease, run by Concept Medical Inc. at 90 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Abluminus DES+ Sirolimus Eluting Stent System (SES) and XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,050 participants
Where
90 sitesin 21 countries
Study dates
15 Jun 2020to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical Inclusion Criteria
  • Patient understands the trial requirements and the treatment procedures and provides written informed consent;
  • Age ≥ 18 years of age (> 19 years of age for South Korea and ≥ 21 years of age for Singapore);
  • Diabetic patient: either:
  • Patient with a previous documented diagnosis of diabetes mellitus (Type 1 or Type 2) and currently undergoing pharmacological treatment (oral hypoglycemic agents or insulin)
  • Newly diagnosed diabetes: either:
Show all 13Show fewer
  • Fasting plasma glucose (FPG) ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for ≥8 hours1 or ii. Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) following a 75g oral glucose tolerance test or iii. HbA1c level ≥ 7% (53 mmol/mol) Patients who are newly diagnosed are included even if they are not on pharmacological treatment (oral hypoglycemic agents or insulin)
  • Symptomatic coronary artery disease including chronic stable angina, silent ischemia, and non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
  • Patient is eligible for percutaneous coronary intervention (PCI); Previous PCI (with balloon angioplasty or stenting) is allowed if performed >12 months before index procedure;
  • Patient is willing and able to comply with all protocol-required follow-up evaluations.
  • Angiographic Inclusion Criteria (visual estimate)
  • Presence of ≥1 de novo coronary artery stenosis >50% in a native coronary artery which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with 1 or multiple stents; and
  • No limitation to the number of treated lesions, number of vessels, or lesion length if the patient is judged eligible for PCI by the treating physician according to the local standard of care.

Who cannot join

  • Clinical Exclusion Criteria
  • Patient lacking capacity (i.e. patient suffering from dementia and others) to provide informed consent
  • Patient in cardiogenic shock;
  • Patient has known allergy to the study stent system or protocol-required concomitant medications (e.g. aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, platinum, chromium, sirolimus, everolimus, radiographic contrast material) that cannot be adequately pre-medicated;
  • Planned surgery (cardiac and non-cardiac) within 6 months after the index procedure unless the dual-antiplatelet therapy (DAPT) can be maintained throughout the peri-surgical period;
  • Patient undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI)
Show all 13Show fewer
  • Patient is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, < 2 years postmenopausal, or does not consistently use effective methods of contraception*;
  • Patient has any other serious medical illness (e.g., cancer, end-stage congestive heart failure) that may reduce life expectancy to less than 12 months;
  • Acute or chronic renal dysfunction (creatinine >3.0 mg/dl);
  • Currently participating in another investigational drug or device study.
  • Angiographic Exclusion Criteria
  • In-stent restenotic lesions;
  • Lesions involving venous or arterial bypass grafts.

Trial locations and contacts

90 sites in 21 countries.

90 sites in 21 countries

Italy15 sites

  • Fondazione Poliambulanza di Brescia

    Brescia

  • P.O. G. Rodolico

    Catania

  • 075/ Magna Graecia University

    Catanzaro

  • GVM - Cotignola

    Cotignola, Ravenna

  • Casa di Cura Montevergine

    Mercogliano

  • Istituto Sant'Ambrogio

    Milan

  • San Carlo Clinic

    Milan

  • San Raffaele Hospital

    Milan

  • 133/Clinica Mederranea

    Naples

  • Division of Cardiology, University of Campania "Luigi Vanvitelli"

    Naples

  • 156/ Policlinico San Matteo

    Pavia

  • Ospedale degli infermi

    Rivoli

  • Azienda Ospedaliera San Camillo Forlanini

    Roma

  • Policlinico Umberto I, "Sapienza" University of Rome Dept.of Cardiovascular, Respiratory, Nephrologic & Anesthesiologic Sciences

    Roma

  • IRCCS - Policlinico San Donato

    San Donato Milanese, Milano

Other trials in Italy

Poland14 sites

  • XII Oddział Kardiologiczny PAKS w Bełchatowie

    Bełchatów

  • Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii

    Bielsko-Biala

  • MCSN AHoP Chrzanow

    Chrzanów

  • Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskie Kliniki Serca

    Dąbrowa Górnicza

  • American Heart of Poland

    Kędzierzyn-Koźle

  • University Hospital Krakow

    Krakow

  • Miedziowe Centrum Zdrowia SA

    Lubin

  • Nyskie Centrum Kardiologiczne Polsko-Amerykańskich Klinik Serca w Nysie

    Nysa

  • Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie

    Pińczów

  • Szpital Kliniczny Przemienienia Pańskiego

    Poznan

  • Oddział Kardiologii Szpitale Polskie Sztum

    Sztum

  • X Department of Invasive Cardiology, Tychy American Heart of Poland SA

    Tychy

  • I Oddział Kardiologii AHoP

    Ustroń

  • Department of Interventional Cardiology Med-Pro American Heart of Poland

    Zgierz

Other trials in Poland

Germany11 sites

  • Klinik für Kardiologie und Angiologie II, Herz-Zentrum Bad Krozingen

    Bad Krozingen

  • Kerckhoff-Klinik GmbH Abteilung Kardiologie/Herzchirurgie

    Bad Nauheim

  • Herzzentrum, Segeberger Kliniken GmbH

    Bad Segeberg

  • Charite Berlin, Department of Cardiology, Campus Benjamin Franklin

    Berlin

  • Helios Amper-Klinikum Dachau, Dept. of Cardiology & Pneumology

    Dachau

  • Elisabeth Krankenhaus Essen

    Essen

  • 121/ MVZ Hamburg, DEU

    Hamburg

  • UKSH, Campus Kiel, Department of Cardiology

    Kiel

  • Heart Center Leipzig

    Leipzig

  • Universitaetsklinikum Tubingen, DEU

    Tübingen

  • Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH

    Villingen-Schwenningen

Other trials in Germany

United Kingdom11 sites

  • Belfast Health and Social Care Trust

    Belfast

  • Royal blackburn hospital

    Blackburn

  • The Royal Bournemouth Hospital

    Bournemouth

  • Brighton & Sussex University NHS Hospitals Trust

    Brighton

  • Golden Jubilee National Hospital

    Clydebank

  • Craigavon Area Hospital

    Craigavon

  • Ninewells Hospital

    Dundee

  • King's College Hospital NHS Foundation Trust

    London

  • Royal Free Hopsital

    London

  • Freeman Hospital

    Newcastle upon Tyne

  • Worcestershire Acute NHS Trust, Worcestershire Royal Hospital

    Worcester

Other trials in United Kingdom

France8 sites

  • Clinique Axium

    Aix-en-Provence

  • CHRU Brest

    Brest

  • Clinique de Fontaine

    Fontaine-lès-Dijon

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble

  • Hôpital La Timone, Service Cardiologie

    Marseille

  • Hôpital Privé Jacques Cartier

    Massy

  • CHU de Nîmes

    Nîmes

  • Hôpital Cochin

    Paris

Other trials in France

Switzerland4 sites

  • Cardiocentro Ticino

    Lugano

  • Hôpital de La Tour

    Meyrin

  • Triemli Hospital

    Zurich

  • University Hospital Zürich

    Zurich

Other trials in Switzerland

Australia3 sites

  • The Prince Charles Hospital

    Chermside

  • St Vincent Hospital

    Melbourne

  • The Wollongong Hospital

    Wollongong

Other trials in Australia

Mexico3 sites

  • Instituto nacional de cardiologia ignacio chavez

    Mexico City

  • Grupo Intervención San Luis - Hospital de Especialidades de la Salud - San Luis Potosí City

    San Luis Potosí City

  • IMSS Hospital de Especialidades UMAE 71

    Torreón

Other trials in Mexico

Austria2 sites

  • University Heart Center Graz

    Graz

  • Kardinal Schwarzenberg Klinikum

    Schwarzach im Pongau

Other trials in Austria

Belgium2 sites

  • Antwerp Cardiovascular Center Middelheim

    Antwerp

  • UZ Leuven

    Leuven

Other trials in Belgium

Brazil2 sites

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo

  • INSTITUTO DO CORAÇÃO - InCor University of São Paulo Medical School

    São Paulo

Other trials in Brazil

Czechia2 sites

  • University Hospital Brno, Department of Medecine Cardiology

    Brno

  • University Hospital Královské Vinohrady, Department of Medecine Cardiology

    Prague

Other trials in Czechia

India2 sites

  • Madras Medical Mission

    Chennai

  • Krishna Institute of Medical Sciences

    Secunderabad

Other trials in India

Netherlands2 sites

  • Amsterdam UMC

    Amsterdam

  • Maasstad Hospital

    Rotterdam

Other trials in Netherlands

Sweden2 sites

  • Örebro Univ. Hospital, Dpt. of cardiology

    Örebro

  • Uppsala University hosp

    Uppsala

Other trials in Sweden

Taiwan2 sites

  • National Cheng Kung University Hospital

    Tainan

  • Mackay Memorial Hospital

    Taipei

Other trials in Taiwan

Bangladesh1 site

  • National Heart Foundation Hospital & Research Institute

    Dhaka

Other trials in Bangladesh

Ireland1 site

  • National University of Ireland, Galway Galway University Hospital

    Galway

Other trials in Ireland

Malaysia1 site

  • Institut Jantung Negara

    Kuala Lumpur

Other trials in Malaysia

Singapore1 site

  • Changi General Hospital

    Singapore

Other trials in Singapore

South Korea1 site

  • Gachon University Gil Medical Center

    Incheon

Other trials in South Korea

About this study

Official title: ABILITY Diabetes Global

To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome

Read the detailed description

This study aims to determine which DES will best treat the diabetic population. Specifically, the research question of this trial is to evaluate the use of a novel sirolimus-eluting stent coated with drug-eluting polymer after crimping on the balloon as compared to the standard-of-care EES in the treatment of de novo coronary artery disease in patients with diabetes mellitus. ABILITY is a prospective, multi-center, multinational, randomized, open label, 2-arm parallel group, post-approval study.

Being tested
Abluminus DES+ Sirolimus Eluting Stent System (SES), XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
Medical subject headings
Diabetes Mellitus, Coronary Artery Disease, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abluminus DES+ Sirolimus Eluting Stent System (SES)Device

    The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical

  • XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)Device

    The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA

Study groups in NCT04236609
Study groupRoleWhat they receive
Abluminus DES+ sirolimus- eluting stents (SES)Active comparatorEnrolled patients will undergo angioplasty with Abluminus DES+ sirolimus- eluting stents (SES) and will be followed for two years. The DES procedure will be conducted in accordance with the CE mark instructions for use for the Abluminus DES+ sirolimus- eluting stents (SES).
Receives: Device: Abluminus DES+ Sirolimus Eluting Stent System (SES)
XIENCE Everolimus-Eluting Stents (EES)Active comparatorEnrolled patients will undergo angioplasty with XIENCE Everolimus-Eluting Stents (EES) and will be followed for two years. The DES procedure will be conducted in accordance with the CE mark instructions for use for the XIENCE Everolimus-Eluting Stents (EES).
Receives: Device: XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Ischemia-driven TLR

    powered for non-inferiority and sequentially superiority

    Measured: 1 year FU

  2. Rate of Target lesion failure TLF

    composite of cardiovascular death, target vessel myocardial infarction [MI], or ischemia driven target lesion revascularization [idTLR])

    Measured: 1 year FU, powered for non-inferiority

Secondary outcomes (4)

  1. Safety composite endpoint

    Safety composite endpoint of the occurrence of cardiovascular death and target-vessel myocardial infarction (MI)

    Measured: 1 year (non-inferiority)

  2. co-primary TLR endpoint

    In case the co-primary TLR endpoint (TLR for non-inferiority) will be demonstrated at 1 year, then the occurrence of ischemia-driven TLR at 2-year FU will be evaluated (efficacy endpoint - superiority)

    Measured: 2 Year FU

  3. Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF)

    Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected:

    1. Death caused by acute MI
    2. Death caused by sudden cardiac, including unwitnessed, death
    3. Death resulting from heart failure
    4. Death caused by stroke
    5. Death caused by cardiovascular procedures
    6. Death resulting from cardiovascular hemorrhage
    7. Death resulting from other cardiovascular cause Any MI not clearly attributable to a non-target vessel will be considered as target-vessel MI.
    • Percutaneous coronary intervention (PCI) related MI is termed type 4a MI.
    • Coronary artery bypass grafting (CABG) related MI is termed type 5 MI. Revascularization is clinically driven if the target lesion diameter stenosis is > 50% by quantitative coronary angiography (QCA) and the subject has clinical or functional ischemia which cannot be explained by another native coronary or bypass graft lesion.

    Measured: 1 year FU

  4. Bleeding

    Bleeding BARC 2 or greater

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start15 Jun 2020
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Target lesions should be treated in accordance with the randomization schedule after meeting the clinical and angiographic inclusion and exclusion criteria following the instruction for use of the study stent. Additional lesions (other vessels) may be staged up to 45 days post-index procedure but must be treated with the same stent. Dual antiplatelet therapy must be prescribed in alignment with the Instructions for Use of the DES and the guidelines
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
3,050 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04236609
Sponsor's protocol ID
COMED.CT.DES.001
Acronym
ABILITY
Status last verified
Oct 2026
First submitted
15 Jan 2020
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • International Diabetes Federation 2015. IDF DIABETES ATLAS Seventh Edition. 2015; ISBN: 978-2-930229-81-2

  • Thiele H, Zeymer U. Chapter: Cardiogenic shock in patients with acute coronary syndromes (p. 441), The ESC Textbook of Intensive and Acute Cardiovascular Care (2 ed.) [IACC]. Edited by Marco Tubaro, Pascal Vranckx, Susanna Price, and Christiaan Vrints. Updated on 22 February 2018 DOI: 10.1093/med/9780199687039.003.0049_update_003

  • Kereiakes DJ, Cutlip DE, Applegate RJ, Wang J, Yaqub M, Sood P, Su X, Su G, Farhat N, Rizvi A, Simonton CA, Sudhir K, Stone GW. Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents: results from the SPIRIT IV clinical trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System). J Am Coll Cardiol. 2010 Dec 14;56(25):2084-9. doi: 10.1016/j.jacc.2010.10.006.

    PubMed 21144968

  • Kufner S, Byrne RA, Dommasch M, Massberg S, Schoemig A, Kastrati A. Comparison of "limus"-eluting stents with permanent-vs biodegradable polymer in patients with diabetes mellitus with coronary artery disease. Eur Heart J 2012; 33: 558-9

  • Stone GW, Kedhi E, Kereiakes DJ, Parise H, Fahy M, Serruys PW, Smits PC. Differential clinical responses to everolimus-eluting and Paclitaxel-eluting coronary stents in patients with and without diabetes mellitus. Circulation. 2011 Aug 23;124(8):893-900. doi: 10.1161/CIRCULATIONAHA.111.031070. Epub 2011 Aug 8.

    PubMed 21824922

  • Cutlip DE, Chhabra AG, Baim DS, Chauhan MS, Marulkar S, Massaro J, Bakhai A, Cohen DJ, Kuntz RE, Ho KK. Beyond restenosis: five-year clinical outcomes from second-generation coronary stent trials. Circulation. 2004 Sep 7;110(10):1226-30. doi: 10.1161/01.CIR.0000140721.27004.4B. Epub 2004 Aug 30.

    PubMed 15337693

  • Lee TT, Feinberg L, Baim DS, Holmes DR, Aroesty JM, Carrozza JP Jr, Cohen DJ, Ho KK, Cutlip DE. Effect of diabetes mellitus on five-year clinical outcomes after single-vessel coronary stenting (a pooled analysis of coronary stent clinical trials). Am J Cardiol. 2006 Sep 15;98(6):718-21. doi: 10.1016/j.amjcard.2006.03.059. Epub 2006 Jul 13.

    PubMed 16950169

  • Morgan KP, Kapur A, Beatt KJ. Anatomy of coronary disease in diabetic patients: an explanation for poorer outcomes after percutaneous coronary intervention and potential target for intervention. Heart. 2004 Jul;90(7):732-8. doi: 10.1136/hrt.2003.021014.

    PubMed 15201238

  • Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.

    PubMed 18200806

  • Schalkwijk CG, Stehouwer CD. Vascular complications in diabetes mellitus: the role of endothelial dysfunction. Clin Sci (Lond). 2005 Aug;109(2):143-59. doi: 10.1042/CS20050025.

    PubMed 16033329

  • Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol. 2010 Nov 30;56(23):1897-907. doi: 10.1016/j.jacc.2010.07.028.

    PubMed 21109112

  • Lightell DJ Jr, Woods TC. Relative resistance to Mammalian target of rapamycin inhibition in vascular smooth muscle cells of diabetic donors. Ochsner J. 2013 Spring;13(1):56-60.

    PubMed 23532775

  • Denardo SJ, Carpinone PL, Vock DM, Batich CD, Pepine CJ. Changes to polymer surface of drug-eluting stents during balloon expansion. JAMA. 2012 May 23;307(20):2148-50. doi: 10.1001/jama.2012.4111. No abstract available.

    PubMed 22618916

  • Popma JJ, Leon MB, Moses JW, Holmes DR Jr, Cox N, Fitzpatrick M, Douglas J, Lambert C, Mooney M, Yakubov S, Kuntz RE; SIRIUS Investigators. Quantitative assessment of angiographic restenosis after sirolimus-eluting stent implantation in native coronary arteries. Circulation. 2004 Dec 21;110(25):3773-80. doi: 10.1161/01.CIR.0000150331.14687.4B. Epub 2004 Dec 13.

    PubMed 15596568

  • Mulukutla SR, Vlachos HA, Marroquin OC, Selzer F, Holper EM, Abbott JD, Laskey WK, Williams DO, Smith C, Anderson WD, Lee JS, Srinivas V, Kelsey SF, Kip KE. Impact of drug-eluting stents among insulin-treated diabetic patients: a report from the National Heart, Lung, and Blood Institute Dynamic Registry. JACC Cardiovasc Interv. 2008 Apr;1(2):139-47. doi: 10.1016/j.jcin.2008.02.005.

    PubMed 19212456

Questions about this trial

What is this clinical trial studying?

A study testing Abluminus DES+ Sirolimus Eluting Stent System (SES) and XIENCE Everolimus Eluting Coronary Stent System (XIENCE family) in people with Diabetes and Coronary Artery Disease, run by Concept Medical Inc. at 90 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in Italy, Poland, Germany, United Kingdom, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Ischemia-driven TLR (time frame: 1 year FU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04236609, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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