ABILITY Diabetes Global

• Sponsor: Concept Medical Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04236609
• Collaborator: (none)
• Enrollment: 3,000
• Locations: 90
• Arms: 2
• Anticipated Duration (Months): 49.5
• Patients Per Site: 33.3
• Patients Per Site Per Month: 0.7

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Coronary Artery Disease; Acute Coronary Syndrome	Device: Abluminus DES+ Sirolimus Eluting Stent System (SES); Device: XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 3000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 guidelinesTarget 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: None (Open Label)
• Primary Purpose: Other
• Official Title: Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global - ABILITY Diabetes Global
• Actual Study Start Date: Jun 15, 2020
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Rate of Ischemia-driven TLR [1 year FU]

   powered for non-inferiority and sequentially superiority

2. Rate of Target lesion failure TLF [1 year FU, powered for non-inferiority]

   composite of cardiovascular death, target vessel myocardial infarction [MI], or ischemia driven target lesion revascularization [idTLR])

Secondary Outcome Measures

1. Safety composite endpoint [1 year (non-inferiority)]

   Safety composite endpoint of the occurrence of cardiovascular death and target-vessel myocardial infarction (MI)

2. co-primary TLR endpoint [2 Year FU]

   In case the co-primary TLR endpoint (TLR for non-inferiority) will be demonstrated at 1 year, then the occurrence of ischemia-driven TLR at 2-year FU will be evaluated (efficacy endpoint - superiority)

3. Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF) [1 year FU]

   Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected: 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.

4. Bleeding [2 year]

   Bleeding BARC 2 or greater

Other Outcome Measures

1. Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF) [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. Occurrence of cardiovascular death and target-vessel myocardial infarction (MI) [2 year]

   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.

3. All-cause mortality [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.

4. Stroke [up to 2 years from procedure]

   according to Neuro-ARC stroke/TIA criteria

5. Stent thrombosis [2 year]

   defined for grade and timing according to the Academic Research Consortium2

6. Technical success [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)

7. Clinical procedural success [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.

8. Occurrence of ischemia-driven TLR [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.

9. Target vessel revascularization (TVR) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

4. Patient with a previous documented diagnosis of diabetes mellitus (Type 1 or Type

1. and currently undergoing pharmacological treatment (oral hypoglycemic agents or insulin)

1. Newly diagnosed diabetes: either:

1. 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)

1. Symptomatic coronary artery disease including chronic stable angina, silent ischemia, and non-ST-segment elevation acute coronary syndrome (NSTE-ACS)

2. Patient is eligible for percutaneous coronary intervention (PCI); Previous PCI (with balloon angioplasty or stenting) is allowed if performed >12 months before index procedure;

3. Patient is willing and able to comply with all protocol-required follow-up evaluations.

Angiographic Inclusion Criteria (visual estimate)

1. 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

2. 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

1. In-stent restenotic lesions;

2. Lesions involving venous or arterial bypass grafts.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Prince Charles Hospital	Chermside		Australia
2	St Vincent Hospital	Melbourne		Australia
3	The Wollongong Hospital	Wollongong		Australia
4	University Heart Center Graz	Graz		Austria
5	Kardinal Schwarzenberg Klinikum	Schwarzach Im Pongau		Austria
6	National Heart Foundation Hospital & Research Institute	Dhaka		Bangladesh
7	Antwerp Cardiovascular Center Middelheim	Antwerpen		Belgium
8	UZ Leuven	Leuven		Belgium
9	Instituto Dante Pazzanese de Cardiologia	São Paulo		Brazil
10	INSTITUTO DO CORAÇÃO - InCor University of São Paulo Medical School	São Paulo		Brazil
11	University Hospital Brno, Department of Medecine Cardiology	Brno		Czechia
12	University Hospital Královské Vinohrady, Department of Medecine Cardiology	Praha		Czechia
13	Clinique Axium	Aix-en-Provence		France
14	CHRU Brest	Brest		France
15	Clinique de Fontaine	Fontaine-lès-Dijon		France
16	Groupe Hospitalier Mutualiste de Grenoble	Grenoble		France
17	Hôpital La Timone, Service Cardiologie	Marseille		France
18	Hôpital Privé Jacques Cartier	Massy		France
19	CHU de Nîmes	Nîmes		France
20	Hôpital Cochin	Paris		France
21	Klinik für Kardiologie und Angiologie II, Herz-Zentrum Bad Krozingen	Bad Krozingen		Germany
22	Kerckhoff-Klinik GmbH Abteilung Kardiologie/Herzchirurgie	Bad Nauheim		Germany
23	Herzzentrum, Segeberger Kliniken GmbH	Bad Segeberg		Germany
24	Charite Berlin, Department of Cardiology, Campus Benjamin Franklin	Berlin		Germany
25	Helios Amper-Klinikum Dachau, Dept. of Cardiology & Pneumology	Dachau		Germany
26	Elisabeth Krankenhaus Essen	Essen		Germany
27	121/ MVZ Hamburg, DEU	Hamburg		Germany
28	UKSH, Campus Kiel, Department of Cardiology	Kiel		Germany
29	Heart Center Leipzig	Leipzig		Germany
30	Universitaetsklinikum Tubingen, DEU	Tuebingen		Germany
31	Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen		Germany
32	Madras Medical Mission	Chennai		India
33	Krishna Institute of Medical Sciences	Secunderabad		India
34	National University of Ireland, Galway Galway University Hospital	Galway		Ireland
35	IRCCS - Policlinico San Donato	San Donato Milanese	Milano	Italy
36	GVM - Cotignola	Cotignola	Ravenna	Italy
37	Fondazione Poliambulanza di Brescia	Brescia		Italy
38	P.O. G. Rodolico	Catania		Italy
39	075/ Magna Graecia University	Catanzaro		Italy
40	Casa di Cura Montevergine	Mercogliano		Italy
41	Istituto Sant'Ambrogio	Milano		Italy
42	San Carlo Clinic	Milano		Italy
43	San Raffaele Hospital	Milano		Italy
44	133/Clinica Mederranea	Napoli		Italy
45	Division of Cardiology, University of Campania "Luigi Vanvitelli"	Napoli		Italy
46	156/ Policlinico San Matteo	Pavia		Italy
47	Ospedale degli infermi	Rivoli		Italy
48	Azienda Ospedaliera San Camillo Forlanini	Roma		Italy
49	Policlinico Umberto I, "Sapienza" University of Rome Dept.of Cardiovascular, Respiratory, Nephrologic & Anesthesiologic Sciences	Roma		Italy
50	Gachon University Gil Medical Center	Incheon		Korea, Republic of
51	Institut Jantung Negara	Kuala Lumpur		Malaysia
52	Instituto nacional de cardiologia ignacio chavez	Mexico City		Mexico
53	Grupo Intervención San Luis - Hospital de Especialidades de la Salud - San Luis Potosí City	San Luis Potosí		Mexico
54	IMSS Hospital de Especialidades UMAE 71	Torreon		Mexico
55	Amsterdam UMC	Amsterdam		Netherlands
56	Maasstad Hospital	Rotterdam		Netherlands
57	XII Oddział Kardiologiczny PAKS w Bełchatowie	Bełchatów		Poland
58	Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii	Bielsko-Biala		Poland
59	MCSN AHoP Chrzanow	Chrzanów		Poland
60	Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskie Kliniki Serca	Dąbrowa Górnicza		Poland
61	University Hospital Krakow	Krakow		Poland
62	American Heart of Poland	Kędzierzyn-Koźle		Poland
63	Miedziowe Centrum Zdrowia SA	Lubin		Poland
64	Nyskie Centrum Kardiologiczne Polsko-Amerykańskich Klinik Serca w Nysie	Nysa		Poland
65	Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie	Pińczów		Poland
66	Szpital Kliniczny Przemienienia Pańskiego	Poznań		Poland
67	Oddział Kardiologii Szpitale Polskie Sztum	Sztum		Poland
68	X Department of Invasive Cardiology, Tychy American Heart of Poland SA	Tychy		Poland
69	I Oddział Kardiologii AHoP	Ustroń		Poland
70	Department of Interventional Cardiology Med-Pro American Heart of Poland	Zgierz		Poland
71	Changi General Hospital	Singapore		Singapore
72	Uppsala University hosp	Uppsala		Sweden
73	Örebro Univ. Hospital, Dpt. of cardiology	Örebro		Sweden
74	Cardiocentro Ticino	Lugano		Switzerland
75	Hôpital de La Tour	Meyrin		Switzerland
76	Triemli Hospital	Zürich		Switzerland
77	University Hospital Zürich	Zürich		Switzerland
78	National Cheng Kung University Hospital	Tainan City		Taiwan
79	Mackay Memorial Hospital	Taipei City		Taiwan
80	Belfast Health and Social Care Trust	Belfast		United Kingdom
81	Royal blackburn hospital	Blackburn		United Kingdom
82	The Royal Bournemouth Hospital	Bournemouth		United Kingdom
83	Brighton & Sussex University NHS Hospitals Trust	Brighton		United Kingdom
84	Golden Jubilee National Hospital	Clydebank		United Kingdom
85	Craigavon Area Hospital	Craigavon		United Kingdom
86	Ninewells Hospital	Dundee		United Kingdom
87	King's College Hospital NHS Foundation Trust	London		United Kingdom
88	Royal Free Hopsital	London		United Kingdom
89	Freeman Hospital	Newcastle Upon Tyne		United Kingdom
90	Worcestershire Acute NHS Trust, Worcestershire Royal Hospital	Worcester		United Kingdom

Sponsors and Collaborators

• Concept Medical Inc.

Investigators

• Study Chair: Roxana Mehran, Mount Sinai Heart

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Concept Medical Inc.
• ClinicalTrials.gov Identifier: NCT04236609
• Other Study ID Numbers: COMED.CT.DES.001
• First Posted: Jan 22, 2020
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome; Diabetes Mellitus; Sirolimus; Everolimus

Study Results

No Results Posted as of Jul 22, 2022