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

Not Applicable

Active, not recruiting

• Conditions: Diabetes; Coronary Artery Disease; Acute Coronary Syndrome
• Interventions: Device: Abluminus DES+ Sirolimus Eluting Stent System (SES); Device: XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)

• Registration Number: NCT04236609
• Lead Sponsor: Concept Medical Inc.

Brief 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

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.

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-22
• Study Start: 2020-06-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-27
• Primary Completion: 2023-10-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3050

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abluminus DES+ sirolimus- eluting stents (SES)	Abluminus DES+ Sirolimus Eluting Stent System (SES)	Enrolled 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).
XIENCE Everolimus-Eluting Stents (EES)	XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)	Enrolled 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).

Primary Outcome Measures

Name	Time	Method
Rate of Ischemia-driven TLR	1 year FU	powered for non-inferiority and sequentially superiority
Rate of Target lesion failure TLF	1 year FU, powered for non-inferiority	composite of cardiovascular death, target vessel myocardial infarction \[MI\], or ischemia driven target lesion revascularization \[idTLR\])

Secondary Outcome Measures

Name	Time	Method
Bleeding	2 year	Bleeding BARC 2 or greater
co-primary TLR endpoint	2 Year FU	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)
Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF)	1 year FU	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.
Safety composite endpoint	1 year (non-inferiority)	Safety composite endpoint of the occurrence of cardiovascular death and target-vessel myocardial infarction (MI)

Trial Locations

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

UZ Leuven; 🇧🇪 Leuven, Belgium

National Heart Foundation Hospital & Research Institute; 🇧🇩 Dhaka, Bangladesh

Antwerp Cardiovascular Center Middelheim; 🇧🇪 Antwerpen, Belgium

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 São Paulo, Brazil

INSTITUTO DO CORAÇÃO - InCor University of São Paulo Medical School; 🇧🇷 São Paulo, Brazil

University Hospital Královské Vinohrady, Department of Medecine Cardiology; 🇨🇿 Praha, Czechia

University Hospital Brno, Department of Medecine Cardiology; 🇨🇿 Brno, Czechia

Clinique Axium; 🇫🇷 Aix-en-Provence, France

Clinique de Fontaine; 🇫🇷 Fontaine-lès-Dijon, France

Groupe Hospitalier Mutualiste de Grenoble; 🇫🇷 Grenoble, France

Hôpital La Timone, Service Cardiologie; 🇫🇷 Marseille, 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

UKSH, Campus Kiel, Department of Cardiology; 🇩🇪 Kiel, Germany

Krishna Institute of Medical Sciences; 🇮🇳 Secunderabad, India

Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH; 🇩🇪 Villingen-Schwenningen, Germany

Madras Medical Mission; 🇮🇳 Chennai, India

National University of Ireland, Galway Galway University Hospital; 🇮🇪 Galway, Ireland

GVM - Cotignola; 🇮🇹 Cotignola, Ravenna, Italy

Casa di Cura Montevergine; 🇮🇹 Mercogliano, Italy

Istituto Sant'Ambrogio; 🇮🇹 Milano, Italy

133/Clinica Mederranea; 🇮🇹 Napoli, Italy

Division of Cardiology, University of Campania "Luigi Vanvitelli"; 🇮🇹 Napoli, Italy

Ospedale degli infermi; 🇮🇹 Rivoli, Italy

Policlinico Umberto I, "Sapienza" University of Rome Dept.of Cardiovascular, Respiratory, Nephrologic & Anesthesiologic Sciences; 🇮🇹 Roma, Italy

American Heart of Poland; 🇵🇱 Kędzierzyn-Koźle, Poland

CHRU Brest; 🇫🇷 Brest, France

CHU de Nîmes; 🇫🇷 Nîmes, France

121/ MVZ Hamburg, DEU; 🇩🇪 Hamburg, Germany

Elisabeth Krankenhaus Essen; 🇩🇪 Essen, Germany

Heart Center Leipzig; 🇩🇪 Leipzig, Germany

Universitaetsklinikum Tubingen, DEU; 🇩🇪 Tuebingen, Germany

IRCCS - Policlinico San Donato; 🇮🇹 San Donato Milanese, Milano, Italy

Fondazione Poliambulanza di Brescia; 🇮🇹 Brescia, Italy

P.O. G. Rodolico; 🇮🇹 Catania, Italy

075/ Magna Graecia University; 🇮🇹 Catanzaro, Italy

San Carlo Clinic; 🇮🇹 Milano, Italy

San Raffaele Hospital; 🇮🇹 Milano, Italy

156/ Policlinico San Matteo; 🇮🇹 Pavia, Italy

Azienda Ospedaliera San Camillo Forlanini; 🇮🇹 Roma, Italy

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Institut Jantung Negara; 🇲🇾 Kuala Lumpur, Malaysia

XII Oddział Kardiologiczny PAKS w Bełchatowie; 🇵🇱 Bełchatów, Poland

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

Grupo Intervención San Luis - Hospital de Especialidades de la Salud - San Luis Potosí City; 🇲🇽 San Luis Potosí, Mexico

Instituto nacional de cardiologia ignacio chavez; 🇲🇽 Mexico City, Mexico

IMSS Hospital de Especialidades UMAE 71; 🇲🇽 Torreon, Mexico

Maasstad Hospital; 🇳🇱 Rotterdam, Netherlands

Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii; 🇵🇱 Bielsko-Biala, Poland

Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskie Kliniki Serca; 🇵🇱 Dąbrowa Górnicza, Poland

University Hospital Krakow; 🇵🇱 Krakow, Poland

MCSN AHoP Chrzanow; 🇵🇱 Chrzanów, Poland

Miedziowe Centrum Zdrowia SA; 🇵🇱 Lubin, Poland

Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie; 🇵🇱 Pińczów, Poland

Oddział Kardiologii Szpitale Polskie Sztum; 🇵🇱 Sztum, Poland

X Department of Invasive Cardiology, Tychy American Heart of Poland SA; 🇵🇱 Tychy, Poland

Department of Interventional Cardiology Med-Pro American Heart of Poland; 🇵🇱 Zgierz, Poland

I Oddział Kardiologii AHoP; 🇵🇱 Ustroń, Poland

Uppsala University hosp; 🇸🇪 Uppsala, Sweden

Changi General Hospital; 🇸🇬 Singapore, Singapore

Cardiocentro Ticino; 🇨🇭 Lugano, Switzerland

Örebro Univ. Hospital, Dpt. of cardiology; 🇸🇪 Örebro, Sweden

Hôpital de La Tour; 🇨🇭 Meyrin, Switzerland

National Cheng Kung University Hospital; 🇨🇳 Tainan City, Taiwan

Mackay Memorial Hospital; 🇨🇳 Taipei City, Taiwan

Royal blackburn hospital; 🇬🇧 Blackburn, United Kingdom

The Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Brighton & Sussex University NHS Hospitals Trust; 🇬🇧 Brighton, United Kingdom

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Golden Jubilee National Hospital; 🇬🇧 Clydebank, United Kingdom

Ninewells Hospital; 🇬🇧 Dundee, United Kingdom

Craigavon Area Hospital; 🇬🇧 Craigavon, United Kingdom

Worcestershire Acute NHS Trust, Worcestershire Royal Hospital; 🇬🇧 Worcester, United Kingdom

Royal Free Hopsital; 🇬🇧 London, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle Upon Tyne, United Kingdom

Triemli Hospital; 🇨🇭 Zürich, Switzerland

Hôpital Privé Jacques Cartier; 🇫🇷 Massy, France

Nyskie Centrum Kardiologiczne Polsko-Amerykańskich Klinik Serca w Nysie; 🇵🇱 Nysa, Poland

University Hospital Zürich; 🇨🇭 Zürich, Switzerland

Szpital Kliniczny Przemienienia Pańskiego; 🇵🇱 Poznań, Poland

Belfast Health and Social Care Trust; 🇬🇧 Belfast, United Kingdom