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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04236609




Registration number
NCT04236609
Ethics application status
Date submitted
15/01/2020
Date registered
22/01/2020
Date last updated
27/03/2023

Titles & IDs
Public title
Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global
Scientific title
ABILITY Diabetes Global
Secondary ID [1] 0 0
COMED.CT.DES.001
Universal Trial Number (UTN)
Trial acronym
ABILITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Coronary Artery Disease 0 0
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Abluminus DES+ Sirolimus Eluting Stent System (SES)
Treatment: Devices - XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)

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).

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).


Treatment: Devices: Abluminus DES+ Sirolimus Eluting Stent System (SES)
The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical

Treatment: Devices: XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Ischemia-driven TLR
Timepoint [1] 0 0
1 year FU
Primary outcome [2] 0 0
Rate of Target lesion failure TLF
Timepoint [2] 0 0
1 year FU, powered for non-inferiority
Secondary outcome [1] 0 0
Safety composite endpoint
Timepoint [1] 0 0
1 year (non-inferiority)
Secondary outcome [2] 0 0
co-primary TLR endpoint
Timepoint [2] 0 0
2 Year FU
Secondary outcome [3] 0 0
Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF)
Timepoint [3] 0 0
1 year FU
Secondary outcome [4] 0 0
Bleeding
Timepoint [4] 0 0
2 year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
Accrual to date
Final
3050
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
St Vincent Hospital - Melbourne
Recruitment hospital [3] 0 0
The Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Schwarzach Im Pongau
Country [3] 0 0
Bangladesh
State/province [3] 0 0
Dhaka
Country [4] 0 0
Belgium
State/province [4] 0 0
Antwerpen
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Brazil
State/province [6] 0 0
São Paulo
Country [7] 0 0
Czechia
State/province [7] 0 0
Brno
Country [8] 0 0
Czechia
State/province [8] 0 0
Praha
Country [9] 0 0
France
State/province [9] 0 0
Aix-en-Provence
Country [10] 0 0
France
State/province [10] 0 0
Brest
Country [11] 0 0
France
State/province [11] 0 0
Fontaine-lès-Dijon
Country [12] 0 0
France
State/province [12] 0 0
Grenoble
Country [13] 0 0
France
State/province [13] 0 0
Marseille
Country [14] 0 0
France
State/province [14] 0 0
Massy
Country [15] 0 0
France
State/province [15] 0 0
Nîmes
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
Germany
State/province [17] 0 0
Bad Krozingen
Country [18] 0 0
Germany
State/province [18] 0 0
Bad Nauheim
Country [19] 0 0
Germany
State/province [19] 0 0
Bad Segeberg
Country [20] 0 0
Germany
State/province [20] 0 0
Berlin
Country [21] 0 0
Germany
State/province [21] 0 0
Dachau
Country [22] 0 0
Germany
State/province [22] 0 0
Essen
Country [23] 0 0
Germany
State/province [23] 0 0
Hamburg
Country [24] 0 0
Germany
State/province [24] 0 0
Kiel
Country [25] 0 0
Germany
State/province [25] 0 0
Leipzig
Country [26] 0 0
Germany
State/province [26] 0 0
Tuebingen
Country [27] 0 0
Germany
State/province [27] 0 0
Villingen-Schwenningen
Country [28] 0 0
India
State/province [28] 0 0
Chennai
Country [29] 0 0
India
State/province [29] 0 0
Secunderabad
Country [30] 0 0
Ireland
State/province [30] 0 0
Galway
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Ravenna
Country [33] 0 0
Italy
State/province [33] 0 0
Brescia
Country [34] 0 0
Italy
State/province [34] 0 0
Catania
Country [35] 0 0
Italy
State/province [35] 0 0
Catanzaro
Country [36] 0 0
Italy
State/province [36] 0 0
Mercogliano
Country [37] 0 0
Italy
State/province [37] 0 0
Napoli
Country [38] 0 0
Italy
State/province [38] 0 0
Pavia
Country [39] 0 0
Italy
State/province [39] 0 0
Rivoli
Country [40] 0 0
Italy
State/province [40] 0 0
Roma
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Incheon
Country [42] 0 0
Malaysia
State/province [42] 0 0
Kuala Lumpur
Country [43] 0 0
Mexico
State/province [43] 0 0
Mexico City
Country [44] 0 0
Mexico
State/province [44] 0 0
San Luis Potosí
Country [45] 0 0
Mexico
State/province [45] 0 0
Torreon
Country [46] 0 0
Netherlands
State/province [46] 0 0
Amsterdam
Country [47] 0 0
Netherlands
State/province [47] 0 0
Rotterdam
Country [48] 0 0
Poland
State/province [48] 0 0
Belchatów
Country [49] 0 0
Poland
State/province [49] 0 0
Bielsko-Biala
Country [50] 0 0
Poland
State/province [50] 0 0
Chrzanów
Country [51] 0 0
Poland
State/province [51] 0 0
Dabrowa Górnicza
Country [52] 0 0
Poland
State/province [52] 0 0
Krakow
Country [53] 0 0
Poland
State/province [53] 0 0
Kedzierzyn-Kozle
Country [54] 0 0
Poland
State/province [54] 0 0
Lubin
Country [55] 0 0
Poland
State/province [55] 0 0
Nysa
Country [56] 0 0
Poland
State/province [56] 0 0
Pinczów
Country [57] 0 0
Poland
State/province [57] 0 0
Poznan
Country [58] 0 0
Poland
State/province [58] 0 0
Sztum
Country [59] 0 0
Poland
State/province [59] 0 0
Tychy
Country [60] 0 0
Poland
State/province [60] 0 0
Ustron
Country [61] 0 0
Poland
State/province [61] 0 0
Zgierz
Country [62] 0 0
Singapore
State/province [62] 0 0
Singapore
Country [63] 0 0
Sweden
State/province [63] 0 0
Uppsala
Country [64] 0 0
Sweden
State/province [64] 0 0
Örebro
Country [65] 0 0
Switzerland
State/province [65] 0 0
Lugano
Country [66] 0 0
Switzerland
State/province [66] 0 0
Meyrin
Country [67] 0 0
Switzerland
State/province [67] 0 0
Zürich
Country [68] 0 0
Taiwan
State/province [68] 0 0
Tainan City
Country [69] 0 0
Taiwan
State/province [69] 0 0
Taipei City
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Belfast
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Blackburn
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Bournemouth
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Brighton
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Clydebank
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Craigavon
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Dundee
Country [77] 0 0
United Kingdom
State/province [77] 0 0
London
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Newcastle Upon Tyne
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Concept Medical Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04236609
Trial related presentations / 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
Public notes

Contacts
Principal investigator
Name 0 0
Roxana Mehran
Address 0 0
Mount Sinai Heart
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04236609