Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global
NCT ID: NCT04236609
Last Updated: 2023-03-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
3050 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-06-15
Study Completion Date
2024-09-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Diabetes
Coronary Artery Disease
Acute Coronary Syndrome
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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
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
Primary Study Purpose
OTHER
Blinding Strategy
DOUBLE
Caregivers
Outcome Assessors
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;
Study Groups
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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).
Group Type
ACTIVE_COMPARATOR
Abluminus DES+ Sirolimus Eluting Stent System (SES)
Intervention Type
DEVICE
The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical
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).
Group Type
ACTIVE_COMPARATOR
XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
Intervention Type
DEVICE
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA
Interventions
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Abluminus DES+ Sirolimus Eluting Stent System (SES)
The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical
Intervention Type
DEVICE
XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA
Intervention Type
DEVICE
Eligibility Criteria
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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.
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.
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.
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
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.
10. In-stent restenotic lesions;
11. Lesions involving venous or arterial bypass grafts.
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.
10. In-stent restenotic lesions;
11. Lesions involving venous or arterial bypass grafts.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Concept Medical Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Roxana Mehran
Role: STUDY_CHAIR
Mount Sinai Heart
Locations
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The Prince Charles Hospital
Chermside, , Australia
Site Status
St Vincent Hospital
Melbourne, , Australia
Site Status
The Wollongong Hospital
Wollongong, , Australia
Site Status
University Heart Center Graz
Graz, , Austria
Site Status
Kardinal Schwarzenberg Klinikum
Schwarzach im Pongau, , Austria
Site Status
National Heart Foundation Hospital & Research Institute
Dhaka, , Bangladesh
Site Status
Antwerp Cardiovascular Center Middelheim
Antwerp, , Belgium
Site Status
UZ Leuven
Leuven, , Belgium
Site Status
Instituto Dante Pazzanese de Cardiologia
São Paulo, , Brazil
Site Status
INSTITUTO DO CORAÇÃO - InCor University of São Paulo Medical School
São Paulo, , Brazil
Site Status
University Hospital Brno, Department of Medecine Cardiology
Brno, , Czechia
Site Status
University Hospital Královské Vinohrady, Department of Medecine Cardiology
Prague, , Czechia
Site Status
Clinique Axium
Aix-en-Provence, , France
Site Status
CHRU Brest
Brest, , France
Site Status
Clinique de Fontaine
Fontaine-lès-Dijon, , France
Site Status
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, , France
Site Status
Hôpital La Timone, Service Cardiologie
Marseille, , France
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Hôpital Privé Jacques Cartier
Massy, , France
Site Status
CHU de Nîmes
Nîmes, , France
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Hôpital Cochin
Paris, , France
Site Status
Klinik für Kardiologie und Angiologie II, Herz-Zentrum Bad Krozingen
Bad Krozingen, , Germany
Site Status
Kerckhoff-Klinik GmbH Abteilung Kardiologie/Herzchirurgie
Bad Nauheim, , Germany
Site Status
Herzzentrum, Segeberger Kliniken GmbH
Bad Segeberg, , Germany
Site Status
Charite Berlin, Department of Cardiology, Campus Benjamin Franklin
Berlin, , Germany
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Helios Amper-Klinikum Dachau, Dept. of Cardiology & Pneumology
Dachau, , Germany
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Elisabeth Krankenhaus Essen
Essen, , Germany
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121/ MVZ Hamburg, DEU
Hamburg, , Germany
Site Status
UKSH, Campus Kiel, Department of Cardiology
Kiel, , Germany
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Heart Center Leipzig
Leipzig, , Germany
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Universitaetsklinikum Tubingen, DEU
Tübingen, , Germany
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Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, , Germany
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Madras Medical Mission
Chennai, , India
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Krishna Institute of Medical Sciences
Secunderabad, , India
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National University of Ireland, Galway Galway University Hospital
Galway, , Ireland
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IRCCS - Policlinico San Donato
San Donato Milanese, Milano, Italy
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GVM - Cotignola
Cotignola, Ravenna, Italy
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Fondazione Poliambulanza di Brescia
Brescia, , Italy
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P.O. G. Rodolico
Catania, , Italy
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075/ Magna Graecia University
Catanzaro, , Italy
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Casa di Cura Montevergine
Mercogliano, , Italy
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Istituto Sant'Ambrogio
Milan, , Italy
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San Carlo Clinic
Milan, , Italy
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San Raffaele Hospital
Milan, , Italy
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133/Clinica Mederranea
Napoli, , Italy
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Division of Cardiology, University of Campania "Luigi Vanvitelli"
Napoli, , Italy
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156/ Policlinico San Matteo
Pavia, , Italy
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Ospedale degli infermi
Rivoli, , Italy
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Azienda Ospedaliera San Camillo Forlanini
Roma, , Italy
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Policlinico Umberto I, "Sapienza" University of Rome Dept.of Cardiovascular, Respiratory, Nephrologic & Anesthesiologic Sciences
Roma, , Italy
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Institut Jantung Negara
Kuala Lumpur, , Malaysia
Site Status
Instituto nacional de cardiologia ignacio chavez
Mexico City, , Mexico
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Grupo Intervención San Luis - Hospital de Especialidades de la Salud - San Luis Potosí City
San Luis Potosí City, , Mexico
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IMSS Hospital de Especialidades UMAE 71
Torreón, , Mexico
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Amsterdam UMC
Amsterdam, , Netherlands
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Maasstad Hospital
Rotterdam, , Netherlands
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XII Oddział Kardiologiczny PAKS w Bełchatowie
Bełchatów, , Poland
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Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
Bielsko-Biala, , Poland
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MCSN AHoP Chrzanow
Chrzanów, , Poland
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Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskie Kliniki Serca
Dąbrowa Górnicza, , Poland
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American Heart of Poland
Kędzierzyn-Koźle, , Poland
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University Hospital Krakow
Krakow, , Poland
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Miedziowe Centrum Zdrowia SA
Lubin, , Poland
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Nyskie Centrum Kardiologiczne Polsko-Amerykańskich Klinik Serca w Nysie
Nysa, , Poland
Site Status
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie
Pińczów, , Poland
Site Status
Szpital Kliniczny Przemienienia Pańskiego
Poznan, , Poland
Site Status
Oddział Kardiologii Szpitale Polskie Sztum
Sztum, , Poland
Site Status
X Department of Invasive Cardiology, Tychy American Heart of Poland SA
Tychy, , Poland
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I Oddział Kardiologii AHoP
Ustroń, , Poland
Site Status
Department of Interventional Cardiology Med-Pro American Heart of Poland
Zgierz, , Poland
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Changi General Hospital
Singapore, , Singapore
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Gachon University Gil Medical Center
Incheon, , South Korea
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Örebro Univ. Hospital, Dpt. of cardiology
Örebro, , Sweden
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Uppsala University hosp
Uppsala, , Sweden
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Cardiocentro Ticino
Lugano, , Switzerland
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Hôpital de La Tour
Meyrin, , Switzerland
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Triemli Hospital
Zurich, , Switzerland
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University Hospital Zürich
Zurich, , Switzerland
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National Cheng Kung University Hospital
Tainan City, , Taiwan
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Mackay Memorial Hospital
Taipei, , Taiwan
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Belfast Health and Social Care Trust
Belfast, , United Kingdom
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Royal blackburn hospital
Blackburn, , United Kingdom
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The Royal Bournemouth Hospital
Bournemouth, , United Kingdom
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Brighton & Sussex University NHS Hospitals Trust
Brighton, , United Kingdom
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Golden Jubilee National Hospital
Clydebank, , United Kingdom
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Craigavon Area Hospital
Craigavon, , United Kingdom
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Ninewells Hospital
Dundee, , United Kingdom
Site Status
King's College Hospital NHS Foundation Trust
London, , United Kingdom
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Royal Free Hopsital
London, , United Kingdom
Site Status
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
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Worcestershire Acute NHS Trust, Worcestershire Royal Hospital
Worcester, , United Kingdom
Site Status
Countries
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Australia
Austria
Bangladesh
Belgium
Brazil
Czechia
France
Germany
India
Ireland
Italy
Malaysia
Mexico
Netherlands
Poland
Singapore
South Korea
Sweden
Switzerland
Taiwan
United Kingdom
References
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International Diabetes Federation 2015. IDF DIABETES ATLAS Seventh Edition. 2015; ISBN: 978-2-930229-81-2
Reference Type
BACKGROUND
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
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BACKGROUND
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.
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RESULT
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
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RESULT
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.
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RESULT
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.
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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.
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RESULT
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.
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Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.
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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.
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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.
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RESULT
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.
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RESULT
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.
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RESULT
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.
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RESULT
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.
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RESULT
Stenestrand U, James SK, Lindback J, Frobert O, Carlsson J, Schersten F, Nilsson T, Lagerqvist B; SCAAR/SWEDEHEART study group. Safety and efficacy of drug-eluting vs. bare metal stents in patients with diabetes mellitus: long-term follow-up in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J. 2010 Jan;31(2):177-86. doi: 10.1093/eurheartj/ehp424. Epub 2009 Nov 10.
Reference Type
RESULT
Maeng M, Jensen LO, Galloe AM, Thayssen P, Christiansen EH, Hansen KN, Helqvist S, Botker HE, Lassen JF, Thuesen L. Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the diabetes and drug-eluting stent (DiabeDES) randomized angiography trial. Am J Cardiol. 2009 Feb 1;103(3):345-9. doi: 10.1016/j.amjcard.2008.09.084. Epub 2008 Nov 12.
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RESULT
Dibra A, Kastrati A, Mehilli J, Pache J, Schuhlen H, von Beckerath N, Ulm K, Wessely R, Dirschinger J, Schomig A; ISAR-DIABETES Study Investigators. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med. 2005 Aug 18;353(7):663-70. doi: 10.1056/NEJMoa044372. Epub 2005 Aug 16.
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RESULT
Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.
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RESULT
Mahmud E, Ormiston JA, Turco MA, Popma JJ, Weissman NJ, O'Shaughnessy CD, Mann T, Hall JJ, McGarry TF, Cannon LA, Webster MW, Mandinov L, Baim DS. TAXUS Liberte attenuates the risk of restenosis in patients with medically treated diabetes mellitus: results from the TAXUS ATLAS program. JACC Cardiovasc Interv. 2009 Mar;2(3):240-52. doi: 10.1016/j.jcin.2008.12.009.
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RESULT
Serruys PW, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, Richardt G, Wiemer M, Carrie D, Thuesen L, Boone E, Miquel-Herbert K, Daemen J. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial. EuroIntervention. 2006 Nov;2(3):286-94.
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RESULT
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RESULT
Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Eur Heart J. 2018 Jun 14;39(23):2192-2207. doi: 10.1093/eurheartj/ehy223.
Reference Type
RESULT
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Reference Type
RESULT
Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045.
Reference Type
RESULT
Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COMED.CT.DES.001
Identifier Type: -
Identifier Source: org_study_id
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