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NCT04236609

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

Sponsor: Concept Medical Inc.

View on ClinicalTrials.gov

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). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome

Official title: ABILITY Diabetes Global

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

3050

Start Date

2020-06-15

Completion Date

2024-11-30

Last Updated

2026-10-26

Healthy Volunteers

Conditions

Diabetes Coronary Artery Disease Acute Coronary Syndrome

Interventions

DEVICE

Abluminus DES+ Sirolimus Eluting Stent System (SES)

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

DEVICE

XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)

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

Inclusion Criteria: Clinical Inclusion Criteria 1. Patient understands the trial requirements and the treatment procedures and provides written informed consent; 2. Age ≥ 18 years of age (\> 19 years of age for South Korea and ≥ 21 years of age for Singapore); 3. Diabetic patient: either: 1. Patient with a previous documented diagnosis of diabetes mellitus (Type 1 or Type 2) and currently undergoing pharmacological treatment (oral hypoglycemic agents or insulin) 2. Newly diagnosed diabetes: either: i. 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) 4. Symptomatic coronary artery disease including chronic stable angina, silent ischemia, and non-ST-segment elevation acute coronary syndrome (NSTE-ACS) 5. Patient is eligible for percutaneous coronary intervention (PCI); Previous PCI (with balloon angioplasty or stenting) is allowed if performed \>12 months before index procedure; 6. Patient is willing and able to comply with all protocol-required follow-up evaluations. Angiographic Inclusion Criteria (visual estimate) 7. 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 8. 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. Exclusion Criteria: Clinical Exclusion Criteria 1. Patient lacking capacity (i.e. patient suffering from dementia and others) to provide informed consent 2. Patient in cardiogenic shock; 3. 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; 4. 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; 5. Patient undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI) 6. 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\*; 7. 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; 8. Acute or chronic renal dysfunction (creatinine \>3.0 mg/dl); 9. Currently participating in another investigational drug or device study. Angiographic Exclusion Criteria 10. In-stent restenotic lesions; 11. Lesions involving venous or arterial bypass grafts.

Locations (90)

The Prince Charles Hospital

Chermside, Australia

St Vincent Hospital

Melbourne, Australia

The Wollongong Hospital

Wollongong, Australia

University Heart Center Graz

Graz, Austria

Kardinal Schwarzenberg Klinikum

Schwarzach im Pongau, Austria

National Heart Foundation Hospital & Research Institute

Dhaka, Bangladesh

Antwerp Cardiovascular Center Middelheim

Antwerp, Belgium

UZ Leuven

Leuven, Belgium

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

INSTITUTO DO CORAÇÃO - InCor University of São Paulo Medical School

São Paulo, Brazil

University Hospital Brno, Department of Medecine Cardiology

Brno, Czechia

University Hospital Královské Vinohrady, Department of Medecine Cardiology

Prague, Czechia

Clinique Axium

Aix-en-Provence, France

CHRU Brest

Brest, France

Clinique de Fontaine

Fontaine-lès-Dijon, France

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, France

Hôpital La Timone, Service Cardiologie

Marseille, France

Hôpital Privé Jacques Cartier

Massy, France

CHU de Nîmes

Nîmes, France

Hôpital Cochin

Paris, France

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

Bad Krozingen, Germany

Kerckhoff-Klinik GmbH Abteilung Kardiologie/Herzchirurgie

Bad Nauheim, Germany

Herzzentrum, Segeberger Kliniken GmbH

Bad Segeberg, Germany

Charite Berlin, Department of Cardiology, Campus Benjamin Franklin

Berlin, Germany

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

Dachau, Germany

Elisabeth Krankenhaus Essen

Essen, Germany

121/ MVZ Hamburg, DEU

Hamburg, Germany

UKSH, Campus Kiel, Department of Cardiology

Kiel, Germany

Heart Center Leipzig

Leipzig, Germany

Universitaetsklinikum Tubingen, DEU

Tübingen, Germany

Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH

Villingen-Schwenningen, Germany

Madras Medical Mission

Chennai, India

Krishna Institute of Medical Sciences

Secunderabad, India

National University of Ireland, Galway Galway University Hospital

Galway, Ireland

IRCCS - Policlinico San Donato

San Donato Milanese, Milano, Italy

GVM - Cotignola

Cotignola, Ravenna, Italy

Fondazione Poliambulanza di Brescia

Brescia, Italy

P.O. G. Rodolico

Catania, Italy

075/ Magna Graecia University

Catanzaro, Italy

Casa di Cura Montevergine

Mercogliano, Italy

Istituto Sant'Ambrogio

Milan, Italy

San Carlo Clinic

Milan, Italy

San Raffaele Hospital

Milan, Italy

133/Clinica Mederranea

Naples, Italy

Division of Cardiology, University of Campania "Luigi Vanvitelli"

Naples, Italy

156/ Policlinico San Matteo

Pavia, Italy

Ospedale degli infermi

Rivoli, Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, Italy

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

Roma, Italy

Institut Jantung Negara

Kuala Lumpur, Malaysia

Instituto nacional de cardiologia ignacio chavez

Mexico City, Mexico

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

San Luis Potosí City, Mexico

IMSS Hospital de Especialidades UMAE 71

Torreón, Mexico

Amsterdam UMC

Amsterdam, Netherlands

Maasstad Hospital

Rotterdam, Netherlands

XII Oddział Kardiologiczny PAKS w Bełchatowie

Bełchatów, Poland

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

Bielsko-Biala, Poland

MCSN AHoP Chrzanow

Chrzanów, Poland

Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskie Kliniki Serca

Dąbrowa Górnicza, Poland

American Heart of Poland

Kędzierzyn-Koźle, Poland

University Hospital Krakow

Krakow, Poland

Miedziowe Centrum Zdrowia SA

Lubin, Poland

Nyskie Centrum Kardiologiczne Polsko-Amerykańskich Klinik Serca w Nysie

Nysa, Poland

Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie

Pińczów, Poland

Szpital Kliniczny Przemienienia Pańskiego

Poznan, Poland

Oddział Kardiologii Szpitale Polskie Sztum

Sztum, Poland

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

Tychy, Poland

I Oddział Kardiologii AHoP

Ustroń, Poland

Department of Interventional Cardiology Med-Pro American Heart of Poland

Zgierz, Poland

Changi General Hospital

Singapore, Singapore

Gachon University Gil Medical Center

Incheon, South Korea

Örebro Univ. Hospital, Dpt. of cardiology

Örebro, Sweden

Uppsala University hosp

Uppsala, Sweden

Cardiocentro Ticino

Lugano, Switzerland

Hôpital de La Tour

Meyrin, Switzerland

Triemli Hospital

Zurich, Switzerland

University Hospital Zürich

Zurich, Switzerland

National Cheng Kung University Hospital

Tainan, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

Belfast Health and Social Care Trust

Belfast, United Kingdom

Royal blackburn hospital

Blackburn, United Kingdom

The Royal Bournemouth Hospital

Bournemouth, United Kingdom

Brighton & Sussex University NHS Hospitals Trust

Brighton, United Kingdom

Golden Jubilee National Hospital

Clydebank, United Kingdom

Craigavon Area Hospital

Craigavon, United Kingdom

Ninewells Hospital

Dundee, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

Royal Free Hopsital

London, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Worcestershire Acute NHS Trust, Worcestershire Royal Hospital

Worcester, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (90)