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

March 24, 2023 updated by: Concept Medical Inc.

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3050

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Chermside, Australia
        • The Prince Charles Hospital
      • Melbourne, Australia
        • St Vincent Hospital
      • Wollongong, Australia
        • The Wollongong Hospital
  • Austria
      • Graz, Austria
        • University Heart Center Graz
      • Schwarzach Im Pongau, Austria
        • Kardinal Schwarzenberg Klinikum
  • Bangladesh
      • Dhaka, Bangladesh
        • National Heart Foundation Hospital & Research Institute
  • Belgium
      • Antwerpen, Belgium
        • Antwerp Cardiovascular Center Middelheim
      • Leuven, Belgium
        • UZ Leuven
  • Brazil
      • São Paulo, Brazil
        • Instituto Dante Pazzanese de Cardiologia
      • São Paulo, Brazil
        • INSTITUTO DO CORAÇÃO - InCor University of São Paulo Medical School
  • Czechia
      • Brno, Czechia
        • University Hospital Brno, Department of Medecine Cardiology
      • Praha, Czechia
        • University Hospital Královské Vinohrady, Department of Medecine Cardiology
  • France
      • Aix-en-Provence, France
        • Clinique Axium
      • Brest, France
        • CHRU Brest
      • Fontaine-lès-Dijon, France
        • Clinique de Fontaine
      • Grenoble, France
        • Groupe Hospitalier Mutualiste de Grenoble
      • Marseille, France
        • Hôpital La Timone, Service Cardiologie
      • Massy, France
        • Hôpital privé Jacques Cartier
      • Nîmes, France
        • CHU de Nimes
      • Paris, France
        • Hôpital Cochin
  • Germany
      • Bad Krozingen, Germany
        • Klinik für Kardiologie und Angiologie II, Herz-Zentrum Bad Krozingen
      • Bad Nauheim, Germany
        • Kerckhoff-Klinik GmbH Abteilung Kardiologie/Herzchirurgie
      • Bad Segeberg, Germany
        • Herzzentrum, Segeberger Kliniken GmbH
      • Berlin, Germany
        • Charite Berlin, Department of Cardiology, Campus Benjamin Franklin
      • Dachau, Germany
        • Helios Amper-Klinikum Dachau, Dept. of Cardiology & Pneumology
      • Essen, Germany
        • Elisabeth Krankenhaus Essen
      • Hamburg, Germany
        • 121/ MVZ Hamburg, DEU
      • Kiel, Germany
        • UKSH, Campus Kiel, Department of Cardiology
      • Leipzig, Germany
        • Heart Center Leipzig
      • Tuebingen, Germany
        • Universitaetsklinikum Tubingen, DEU
      • Villingen-Schwenningen, Germany
        • Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH
  • India
      • Chennai, India
        • Madras Medical Mission
      • Secunderabad, India
        • Krishna Institute of Medical Sciences
  • Ireland
      • Galway, Ireland
        • National University of Ireland, Galway Galway University Hospital
  • Italy
      • Brescia, Italy
        • Fondazione Poliambulanza di Brescia
      • Catania, Italy
        • P.O. G. Rodolico
      • Catanzaro, Italy
        • 075/ Magna Graecia University
      • Mercogliano, Italy
        • Casa di Cura Montevergine
      • Milano, Italy
        • Istituto Sant'Ambrogio
      • Milano, Italy
        • San Carlo Clinic
      • Milano, Italy
        • San Raffaele Hospital
      • Napoli, Italy
        • 133/Clinica Mederranea
      • Napoli, Italy
        • Division of Cardiology, University of Campania "Luigi Vanvitelli"
      • Pavia, Italy
        • 156/ Policlinico San Matteo
      • Rivoli, Italy
        • Ospedale degli Infermi
      • Roma, Italy
        • Azienda Ospedaliera San Camillo Forlanini
      • Roma, Italy
        • Policlinico Umberto I, "Sapienza" University of Rome Dept.of Cardiovascular, Respiratory, Nephrologic & Anesthesiologic Sciences
    • Milano
      • San Donato Milanese, Milano, Italy
        • IRCCS - Policlinico San Donato
    • Ravenna
      • Cotignola, Ravenna, Italy
        • GVM - Cotignola
  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Gachon University Gil Medical Center
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Institut Jantung Negara
  • Mexico
      • Mexico City, Mexico
        • Instituto Nacional de Cardiologia Ignacio Chavez
      • San Luis Potosí, Mexico
        • Grupo Intervención San Luis - Hospital de Especialidades de la Salud - San Luis Potosí City
      • Torreon, Mexico
        • IMSS Hospital de Especialidades UMAE 71
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC
      • Rotterdam, Netherlands
        • Maasstad Hospital
  • Poland
      • Bełchatów, Poland
        • XII Oddział Kardiologiczny PAKS w Bełchatowie
      • Bielsko-Biala, Poland
        • Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
      • Chrzanów, Poland
        • MCSN AHoP Chrzanow
      • Dąbrowa Górnicza, Poland
        • Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskie Kliniki Serca
      • Krakow, Poland
        • University Hospital Krakow
      • Kędzierzyn-Koźle, Poland
        • American Heart of Poland
      • Lubin, Poland
        • Miedziowe Centrum Zdrowia SA
      • Nysa, Poland
        • Nyskie Centrum Kardiologiczne Polsko-Amerykańskich Klinik Serca w Nysie
      • Pińczów, Poland
        • Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie
      • Poznań, Poland
        • Szpital Kliniczny Przemienienia Pańskiego
      • Sztum, Poland
        • Oddział Kardiologii Szpitale Polskie Sztum
      • Tychy, Poland
        • X Department of Invasive Cardiology, Tychy American Heart of Poland SA
      • Ustroń, Poland
        • I Oddział Kardiologii AHoP
      • Zgierz, Poland
        • Department of Interventional Cardiology Med-Pro American Heart of Poland
  • Singapore
      • Singapore, Singapore
        • Changi General Hospital
  • Sweden
      • Uppsala, Sweden
        • Uppsala University hosp
      • Örebro, Sweden
        • Örebro Univ. Hospital, Dpt. of cardiology
  • Switzerland
      • Lugano, Switzerland
        • Cardiocentro Ticino
      • Meyrin, Switzerland
        • Hôpital de La Tour
      • Zürich, Switzerland
        • University Hospital Zurich
      • Zürich, Switzerland
        • Triemli Hospital
  • Taiwan
      • Tainan City, Taiwan
        • National Cheng Kung University Hospital
      • Taipei City, Taiwan
        • Mackay Memorial Hospital
  • United Kingdom
      • Belfast, United Kingdom
        • Belfast Health and Social Care Trust
      • Blackburn, United Kingdom
        • Royal Blackburn Hospital
      • Bournemouth, United Kingdom
        • The Royal Bournemouth Hospital
      • Brighton, United Kingdom
        • Brighton & Sussex University NHS Hospitals Trust
      • Clydebank, United Kingdom
        • Golden Jubilee National Hospital
      • Craigavon, United Kingdom
        • Craigavon Area Hospital
      • Dundee, United Kingdom
        • Ninewells Hospital
      • London, United Kingdom
        • King's College Hospital NHS Foundation Trust
      • London, United Kingdom
        • Royal Free Hopsital
      • Newcastle Upon Tyne, United Kingdom
        • Freeman Hospital
      • Worcester, United Kingdom
        • Worcestershire Acute NHS Trust, Worcestershire Royal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Abluminus DES+ sirolimus- eluting stents (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).
Device: Abluminus DES+ Sirolimus Eluting Stent System (SES)
The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical
Active Comparator: XIENCE Everolimus-Eluting Stents (EES)
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).
Device: XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF)
Time Frame: 2 year FU

Cardiovascular death is defined as death resulting from cardiovascular causes. Any MI not clearly attributable to a non-target vessel will be considered as target-vessel 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.
2 year FU
Occurrence of cardiovascular death and target-vessel myocardial infarction (MI)
Time Frame: 2 year

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.
2 year
All-cause mortality
Time Frame: up to 2 years from procedure
all deaths are considered cardiovascular unless an alternate cause is unequivocally established, even among subjects with serious noncardiac comorbidities.
up to 2 years from procedure
Stroke
Time Frame: up to 2 years from procedure
according to Neuro-ARC stroke/TIA criteria
up to 2 years from procedure
Stent thrombosis
Time Frame: 2 year
defined for grade and timing according to the Academic Research Consortium2
2 year
Technical success
Time Frame: 2 year
Technical success is defined as the ability to cross the occluded segment with both a wire and a balloon, and successfully open the artery; the restoration of antegrade TIMI flow 2 or 3 and a <30% residual stenosis. (As applies to chronic total occlusion - CTO - lesions)
2 year
Clinical procedural success
Time Frame: 2 year

In the case of percutaneous intervention for obstructive lesions, procedural success is defined as the achievement of a final residual diameter stenosis < 30% by angiography at the end of the procedure (and without flow limiting arterial dissection and hemodynamically significant translesional pressure gradient) without any in-hospital major adverse events (death, acute onset of limb ischemia, need for urgent/emergent vascular surgery). The balloon inflation and/or stent placement may be preceded by use of adjunctive devices (e.g., percutaneous mechanical thrombectomy, directional or rotational atherectomy, laser, chronic total occlusion crossing device).

Ideally, the assessment of the residual stenosis at the end of the procedure should be performed by an angiographic core laboratory.
2 year
Occurrence of ischemia-driven TLR
Time Frame: 2 year FU
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.
2 year FU
Target vessel revascularization (TVR)
Time Frame: up to 2 years
TLR is a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Concept Medical Inc.

Investigators

  • Study Chair: Roxana Mehran, Mount Sinai Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Anticipated)

October 30, 2023

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMED.CT.DES.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 Coronary Artery Disease

Clinical Trials on Abluminus DES+ Sirolimus Eluting Stent System (SES)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe