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

Primary Purpose

Diabetes, Coronary Artery Disease, Acute Coronary Syndrome

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Abluminus DES+ Sirolimus Eluting Stent System (SES)
XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
Sponsored by
Concept Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Prince Charles Hospital
  • St Vincent Hospital
  • The Wollongong Hospital
  • University Heart Center Graz
  • Kardinal Schwarzenberg Klinikum
  • National Heart Foundation Hospital & Research Institute
  • Antwerp Cardiovascular Center Middelheim
  • UZ Leuven
  • Instituto Dante Pazzanese de Cardiologia
  • INSTITUTO DO CORAÇÃO - InCor University of São Paulo Medical School
  • University Hospital Brno, Department of Medecine Cardiology
  • University Hospital Královské Vinohrady, Department of Medecine Cardiology
  • Clinique Axium
  • CHRU Brest
  • Clinique de Fontaine
  • Groupe Hospitalier Mutualiste de Grenoble
  • Hôpital La Timone, Service Cardiologie
  • Hôpital Privé Jacques Cartier
  • CHU de Nîmes
  • Hôpital Cochin
  • Klinik für Kardiologie und Angiologie II, Herz-Zentrum Bad Krozingen
  • Kerckhoff-Klinik GmbH Abteilung Kardiologie/Herzchirurgie
  • Herzzentrum, Segeberger Kliniken GmbH
  • Charite Berlin, Department of Cardiology, Campus Benjamin Franklin
  • Helios Amper-Klinikum Dachau, Dept. of Cardiology & Pneumology
  • Elisabeth Krankenhaus Essen
  • 121/ MVZ Hamburg, DEU
  • UKSH, Campus Kiel, Department of Cardiology
  • Heart Center Leipzig
  • Universitaetsklinikum Tubingen, DEU
  • Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH
  • Madras Medical Mission
  • Krishna Institute of Medical Sciences
  • National University of Ireland, Galway Galway University Hospital
  • IRCCS - Policlinico San Donato
  • GVM - Cotignola
  • Fondazione Poliambulanza di Brescia
  • P.O. G. Rodolico
  • 075/ Magna Graecia University
  • Casa di Cura Montevergine
  • Istituto Sant'Ambrogio
  • San Carlo Clinic
  • San Raffaele Hospital
  • 133/Clinica Mederranea
  • Division of Cardiology, University of Campania "Luigi Vanvitelli"
  • 156/ Policlinico San Matteo
  • Ospedale degli infermi
  • Azienda Ospedaliera San Camillo Forlanini
  • Policlinico Umberto I, "Sapienza" University of Rome Dept.of Cardiovascular, Respiratory, Nephrologic & Anesthesiologic Sciences
  • Gachon University Gil Medical Center
  • Institut Jantung Negara
  • Instituto nacional de cardiologia ignacio chavez
  • Grupo Intervención San Luis - Hospital de Especialidades de la Salud - San Luis Potosí City
  • IMSS Hospital de Especialidades UMAE 71
  • Amsterdam UMC
  • Maasstad Hospital
  • XII Oddział Kardiologiczny PAKS w Bełchatowie
  • Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
  • MCSN AHoP Chrzanow
  • Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskie Kliniki Serca
  • University Hospital Krakow
  • American Heart of Poland
  • Miedziowe Centrum Zdrowia SA
  • Nyskie Centrum Kardiologiczne Polsko-Amerykańskich Klinik Serca w Nysie
  • Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie
  • Szpital Kliniczny Przemienienia Pańskiego
  • Oddział Kardiologii Szpitale Polskie Sztum
  • X Department of Invasive Cardiology, Tychy American Heart of Poland SA
  • I Oddział Kardiologii AHoP
  • Department of Interventional Cardiology Med-Pro American Heart of Poland
  • Changi General Hospital
  • Uppsala University hosp
  • Örebro Univ. Hospital, Dpt. of cardiology
  • Cardiocentro Ticino
  • Hôpital de La Tour
  • Triemli Hospital
  • University Hospital Zürich
  • National Cheng Kung University Hospital
  • Mackay Memorial Hospital
  • Belfast Health and Social Care Trust
  • Royal blackburn hospital
  • The Royal Bournemouth Hospital
  • Brighton & Sussex University NHS Hospitals Trust
  • Golden Jubilee National Hospital
  • Craigavon Area Hospital
  • Ninewells Hospital
  • King's College Hospital NHS Foundation Trust
  • Royal Free Hopsital
  • Freeman Hospital
  • Worcestershire Acute NHS Trust, Worcestershire Royal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Abluminus DES+ sirolimus- eluting stents (SES)

XIENCE Everolimus-Eluting Stents (EES)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety composite endpoint
Safety composite endpoint of the occurrence of cardiovascular death and target-vessel myocardial infarction (MI)
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)
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: Death caused by acute MI Death caused by sudden cardiac, including unwitnessed, death Death resulting from heart failure Death caused by stroke Death caused by cardiovascular procedures Death resulting from cardiovascular hemorrhage 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.
Bleeding
Bleeding BARC 2 or greater

Full Information

First Posted
January 15, 2020
Last Updated
March 24, 2023
Sponsor
Concept Medical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04236609
Brief Title
Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global
Acronym
ABILITY
Official Title
ABILITY Diabetes Global
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concept Medical Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Coronary Artery Disease, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderOutcomes Assessor
Masking Description
The staff (i.e. research nurses, research coordinators and other practitioners) involved in the follow-up care of study subjects and the Clinical Events Committee (CEC) adjudicators will be blinded to the patient assignment;
Allocation
Randomized
Enrollment
3050 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abluminus DES+ sirolimus- eluting stents (SES)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
XIENCE Everolimus-Eluting Stents (EES)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Abluminus DES+ Sirolimus Eluting Stent System (SES)
Intervention Description
The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical
Intervention Type
Device
Intervention Name(s)
XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
Intervention Description
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA
Primary Outcome Measure Information:
Title
Rate of Ischemia-driven TLR
Description
powered for non-inferiority and sequentially superiority
Time Frame
1 year FU
Title
Rate of Target lesion failure TLF
Description
composite of cardiovascular death, target vessel myocardial infarction [MI], or ischemia driven target lesion revascularization [idTLR])
Time Frame
1 year FU, powered for non-inferiority
Secondary Outcome Measure Information:
Title
Safety composite endpoint
Description
Safety composite endpoint of the occurrence of cardiovascular death and target-vessel myocardial infarction (MI)
Time Frame
1 year (non-inferiority)
Title
co-primary TLR endpoint
Description
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)
Time Frame
2 Year FU
Title
Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF)
Description
Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected: Death caused by acute MI Death caused by sudden cardiac, including unwitnessed, death Death resulting from heart failure Death caused by stroke Death caused by cardiovascular procedures Death resulting from cardiovascular hemorrhage 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.
Time Frame
1 year FU
Title
Bleeding
Description
Bleeding BARC 2 or greater
Time Frame
2 year
Other Pre-specified Outcome Measures:
Title
Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF)
Description
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.
Time Frame
2 year FU
Title
Occurrence of cardiovascular death and target-vessel myocardial infarction (MI)
Description
Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected: Death caused by acute MI Death caused by sudden cardiac, including unwitnessed, death Death resulting from heart failure Death caused by stroke Death caused by cardiovascular procedures Death resulting from cardiovascular hemorrhage 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.
Time Frame
2 year
Title
All-cause mortality
Description
all deaths are considered cardiovascular unless an alternate cause is unequivocally established, even among subjects with serious noncardiac comorbidities.
Time Frame
up to 2 years from procedure
Title
Stroke
Description
according to Neuro-ARC stroke/TIA criteria
Time Frame
up to 2 years from procedure
Title
Stent thrombosis
Description
defined for grade and timing according to the Academic Research Consortium2
Time Frame
2 year
Title
Technical success
Description
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)
Time Frame
2 year
Title
Clinical procedural success
Description
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.
Time Frame
2 year
Title
Occurrence of ischemia-driven TLR
Description
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.
Time Frame
2 year FU
Title
Target vessel revascularization (TVR)
Description
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.
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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) 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. Exclusion Criteria: 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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roxana Mehran
Organizational Affiliation
Mount Sinai Heart
Official's Role
Study Chair
Facility Information:
Facility Name
The Prince Charles Hospital
City
Chermside
Country
Australia
Facility Name
St Vincent Hospital
City
Melbourne
Country
Australia
Facility Name
The Wollongong Hospital
City
Wollongong
Country
Australia
Facility Name
University Heart Center Graz
City
Graz
Country
Austria
Facility Name
Kardinal Schwarzenberg Klinikum
City
Schwarzach Im Pongau
Country
Austria
Facility Name
National Heart Foundation Hospital & Research Institute
City
Dhaka
Country
Bangladesh
Facility Name
Antwerp Cardiovascular Center Middelheim
City
Antwerpen
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
São Paulo
Country
Brazil
Facility Name
INSTITUTO DO CORAÇÃO - InCor University of São Paulo Medical School
City
São Paulo
Country
Brazil
Facility Name
University Hospital Brno, Department of Medecine Cardiology
City
Brno
Country
Czechia
Facility Name
University Hospital Královské Vinohrady, Department of Medecine Cardiology
City
Praha
Country
Czechia
Facility Name
Clinique Axium
City
Aix-en-Provence
Country
France
Facility Name
CHRU Brest
City
Brest
Country
France
Facility Name
Clinique de Fontaine
City
Fontaine-lès-Dijon
Country
France
Facility Name
Groupe Hospitalier Mutualiste de Grenoble
City
Grenoble
Country
France
Facility Name
Hôpital La Timone, Service Cardiologie
City
Marseille
Country
France
Facility Name
Hôpital Privé Jacques Cartier
City
Massy
Country
France
Facility Name
CHU de Nîmes
City
Nîmes
Country
France
Facility Name
Hôpital Cochin
City
Paris
Country
France
Facility Name
Klinik für Kardiologie und Angiologie II, Herz-Zentrum Bad Krozingen
City
Bad Krozingen
Country
Germany
Facility Name
Kerckhoff-Klinik GmbH Abteilung Kardiologie/Herzchirurgie
City
Bad Nauheim
Country
Germany
Facility Name
Herzzentrum, Segeberger Kliniken GmbH
City
Bad Segeberg
Country
Germany
Facility Name
Charite Berlin, Department of Cardiology, Campus Benjamin Franklin
City
Berlin
Country
Germany
Facility Name
Helios Amper-Klinikum Dachau, Dept. of Cardiology & Pneumology
City
Dachau
Country
Germany
Facility Name
Elisabeth Krankenhaus Essen
City
Essen
Country
Germany
Facility Name
121/ MVZ Hamburg, DEU
City
Hamburg
Country
Germany
Facility Name
UKSH, Campus Kiel, Department of Cardiology
City
Kiel
Country
Germany
Facility Name
Heart Center Leipzig
City
Leipzig
Country
Germany
Facility Name
Universitaetsklinikum Tubingen, DEU
City
Tuebingen
Country
Germany
Facility Name
Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH
City
Villingen-Schwenningen
Country
Germany
Facility Name
Madras Medical Mission
City
Chennai
Country
India
Facility Name
Krishna Institute of Medical Sciences
City
Secunderabad
Country
India
Facility Name
National University of Ireland, Galway Galway University Hospital
City
Galway
Country
Ireland
Facility Name
IRCCS - Policlinico San Donato
City
San Donato Milanese
State/Province
Milano
Country
Italy
Facility Name
GVM - Cotignola
City
Cotignola
State/Province
Ravenna
Country
Italy
Facility Name
Fondazione Poliambulanza di Brescia
City
Brescia
Country
Italy
Facility Name
P.O. G. Rodolico
City
Catania
Country
Italy
Facility Name
075/ Magna Graecia University
City
Catanzaro
Country
Italy
Facility Name
Casa di Cura Montevergine
City
Mercogliano
Country
Italy
Facility Name
Istituto Sant'Ambrogio
City
Milano
Country
Italy
Facility Name
San Carlo Clinic
City
Milano
Country
Italy
Facility Name
San Raffaele Hospital
City
Milano
Country
Italy
Facility Name
133/Clinica Mederranea
City
Napoli
Country
Italy
Facility Name
Division of Cardiology, University of Campania "Luigi Vanvitelli"
City
Napoli
Country
Italy
Facility Name
156/ Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
Ospedale degli infermi
City
Rivoli
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
Country
Italy
Facility Name
Policlinico Umberto I, "Sapienza" University of Rome Dept.of Cardiovascular, Respiratory, Nephrologic & Anesthesiologic Sciences
City
Roma
Country
Italy
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Institut Jantung Negara
City
Kuala Lumpur
Country
Malaysia
Facility Name
Instituto nacional de cardiologia ignacio chavez
City
Mexico City
Country
Mexico
Facility Name
Grupo Intervención San Luis - Hospital de Especialidades de la Salud - San Luis Potosí City
City
San Luis Potosí
Country
Mexico
Facility Name
IMSS Hospital de Especialidades UMAE 71
City
Torreon
Country
Mexico
Facility Name
Amsterdam UMC
City
Amsterdam
Country
Netherlands
Facility Name
Maasstad Hospital
City
Rotterdam
Country
Netherlands
Facility Name
XII Oddział Kardiologiczny PAKS w Bełchatowie
City
Bełchatów
Country
Poland
Facility Name
Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
City
Bielsko-Biala
Country
Poland
Facility Name
MCSN AHoP Chrzanow
City
Chrzanów
Country
Poland
Facility Name
Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskie Kliniki Serca
City
Dąbrowa Górnicza
Country
Poland
Facility Name
University Hospital Krakow
City
Krakow
Country
Poland
Facility Name
American Heart of Poland
City
Kędzierzyn-Koźle
Country
Poland
Facility Name
Miedziowe Centrum Zdrowia SA
City
Lubin
Country
Poland
Facility Name
Nyskie Centrum Kardiologiczne Polsko-Amerykańskich Klinik Serca w Nysie
City
Nysa
Country
Poland
Facility Name
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie
City
Pińczów
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Pańskiego
City
Poznań
Country
Poland
Facility Name
Oddział Kardiologii Szpitale Polskie Sztum
City
Sztum
Country
Poland
Facility Name
X Department of Invasive Cardiology, Tychy American Heart of Poland SA
City
Tychy
Country
Poland
Facility Name
I Oddział Kardiologii AHoP
City
Ustroń
Country
Poland
Facility Name
Department of Interventional Cardiology Med-Pro American Heart of Poland
City
Zgierz
Country
Poland
Facility Name
Changi General Hospital
City
Singapore
Country
Singapore
Facility Name
Uppsala University hosp
City
Uppsala
Country
Sweden
Facility Name
Örebro Univ. Hospital, Dpt. of cardiology
City
Örebro
Country
Sweden
Facility Name
Cardiocentro Ticino
City
Lugano
Country
Switzerland
Facility Name
Hôpital de La Tour
City
Meyrin
Country
Switzerland
Facility Name
Triemli Hospital
City
Zürich
Country
Switzerland
Facility Name
University Hospital Zürich
City
Zürich
Country
Switzerland
Facility Name
National Cheng Kung University Hospital
City
Tainan City
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei City
Country
Taiwan
Facility Name
Belfast Health and Social Care Trust
City
Belfast
Country
United Kingdom
Facility Name
Royal blackburn hospital
City
Blackburn
Country
United Kingdom
Facility Name
The Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Facility Name
Brighton & Sussex University NHS Hospitals Trust
City
Brighton
Country
United Kingdom
Facility Name
Golden Jubilee National Hospital
City
Clydebank
Country
United Kingdom
Facility Name
Craigavon Area Hospital
City
Craigavon
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Royal Free Hopsital
City
London
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
Country
United Kingdom
Facility Name
Worcestershire Acute NHS Trust, Worcestershire Royal Hospital
City
Worcester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Learn more about this trial

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

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