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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04236609
Other study ID # COMED.CT.DES.001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 15, 2020
Est. completion date September 30, 2024

Study information

Verified date March 2023
Source Concept Medical Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3050
Est. completion date September 30, 2024
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Intervention

Device:
Abluminus DES+ Sirolimus Eluting Stent System (SES)
The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical
XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Concept Medical Inc.

Countries where clinical trial is conducted

Australia,  Austria,  Bangladesh,  Belgium,  Brazil,  Czechia,  France,  Germany,  India,  Ireland,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Poland,  Singapore,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

References & Publications (26)

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.C — View Citation

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. — View Citation

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. — View Citation

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. 2 — View Citation

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 P — View Citation

Grube E, Chevalier B, Guagliumi G, Smits PC, Stuteville M, Dorange C, Papeleu P, Kaul U, Dzavik V. The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberte paclitaxel-eluting stent in diab — View Citation

Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76. — View Citation

International Diabetes Federation 2015. IDF DIABETES ATLAS Seventh Edition. 2015; ISBN: 978-2-930229-81-2

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 — View Citation

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

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 M — View Citation

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 Ca — View Citation

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. — View Citation

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-elut — View Citation

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: result — View Citation

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 ca — View Citation

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. — View Citation

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 — View Citation

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 ar — View Citation

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. — View Citation

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 SPI — View Citation

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 Swedis — View Citation

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. — View Citation

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 co — View Citation

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

Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task — View Citation

* Note: There are 26 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF) 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
Other Occurrence of cardiovascular death and target-vessel myocardial infarction (MI) 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.
2 year
Other All-cause mortality 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
Other Stroke according to Neuro-ARC stroke/TIA criteria up to 2 years from procedure
Other Stent thrombosis defined for grade and timing according to the Academic Research Consortium2 2 year
Other Technical success 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
Other Clinical procedural success 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
Other Occurrence of ischemia-driven TLR 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
Other Target vessel revascularization (TVR) 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
Primary Rate of Ischemia-driven TLR powered for non-inferiority and sequentially superiority 1 year FU
Primary Rate of Target lesion failure TLF composite of cardiovascular death, target vessel myocardial infarction [MI], or ischemia driven target lesion revascularization [idTLR]) 1 year FU, powered for non-inferiority
Secondary Safety composite endpoint Safety composite endpoint of the occurrence of cardiovascular death and target-vessel myocardial infarction (MI) 1 year (non-inferiority)
Secondary 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) 2 Year FU
Secondary 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.
1 year FU
Secondary Bleeding Bleeding BARC 2 or greater 2 year
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