Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents versus Everolimus-Eluting Stents in Coronary Artery Disease Patients with Diabetes Mellitus Global (ABILITY Diabetes Global)
- Conditions
- coronary artery disease100110821001842410003816
- Registration Number
- NL-OMON54418
- Lead Sponsor
- Concept Medical Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 451
Clinical Inclusion Criteria 1. Patient understands the
trial requirements and the treatment procedures and provides written informed
consent; 2. Age >= 18 years (>= 19 years of age for South Korea and >= 21 years of
age for Singapore); 3. Diabetic patients: either: a. Patient with a previous
documented diagnosis of diabetes mellitus (Type 1 or Type 2) and currently
undergoing pharmacological treatment (oral hypoglycemic agents or insulin) b.
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 hours 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.
Clinical Exclusion Criteria: 1. Patient lacking capacity
(i.e. patient suffering from dementia and others) to provide informed consent
2. Patients in cardiogenic shock as defined in appendix A; 3. Patient has known
allergy to the study stent system or protocol-required concomitant medications
(e.g. aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel,
cobalt, 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.Patients 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 (serum
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Primary:<br /><br><br /><br>o Ischemia-driven Target Lesion Revascularization (idTLR) at 1-year Follow-Up<br /><br>(powered for non-inferiority and sequentially superiority).<br /><br><br /><br>o Target lesion failure (TLF - composite of cardiovascular death, target vessel<br /><br>myocardial infarction [MI], or ischemia driven target lesion<br /><br>revascularization) at 1-year FU, powered for non-inferiority </p><br>
- Secondary Outcome Measures
Name Time Method