ABILITY Diabetes Global

  • STATUS
    Recruiting
  • End date
    Apr 25, 2024
  • participants needed
    3000
  • sponsor
    Concept Medical Inc.
Updated on 25 January 2021
diabetes
stenosis
insulin
sirolimus
diabetes mellitus
fasting
everolimus
oral glucose tolerance test
hba1c
angina pectoris
percutaneous coronary intervention
ischemia
coronary artery stenosis
stable angina
acute coronary syndrome
coronary angioplasty
hemoglobin a1c
glycosylated hemoglobin
glucose tolerance test
arterial disease
plasma glucose
hypoglycemic agents
oral hypoglycemic

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.

Details
Condition NIDDM, Diabetes Mellitus, Coronary Artery Disease, Coronary heart disease, Acute Coronary Syndrome, Ischemic Heart Disease, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Cardiac Ischemia, Myocardial Ischemia, Diabetes Mellitus Type 2, Diabetes, type 2 diabetes mellitus, acute coronary syndromes, diabetes mellitus (dm), type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Abluminus DES+ Sirolimus Eluting Stent System (SES), XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
Clinical Study IdentifierNCT04236609
SponsorConcept Medical Inc.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
and currently undergoing pharmacological treatment (oral hypoglycemic agents or insulin)
Newly diagnosed diabetes: either
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
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