coronary artery disease
Conditions
Interventions
The included patients will undergo a Percutaneous coronary intervention (PCI)
with either Abluminus/Abluminus DES+ sirolimus-eluting stents (SES) or
Everolimus-Eluting Stents (EES).
Sponsors
Concept Medical Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Primary: o Ischemia-driven Target Lesion Revascularization (idTLR) at 1-year Follow-Up (powered for non-inferiority and sequentially superiority). o Target lesion failure (TLF - composite of cardiovascular death, target vessel myocardial infarction [MI], or ischemia driven target lesion revascularization) at 1-year FU, powered for non-inferiority | — |
Secondary
| Measure | Time frame |
|---|---|
| -- Secondary: 1) Safety composite endpoint of the occurrence of cardiovascular death and target-vessel myocardial infarction (MI) at 1 year (non-inferiority). 2) In case the co-primary TLR endpoint (TLR for non-inferiority) will be demonstrated at 1 year, then the occurrence of idTLR at 2-year FU will be evaluated (efficacy endpoint - superiority). 3) In case the co-primary TLF endpoint (TLF for non-inferiority) will be demonstrated at 1 year, then the occurrence of the composite of cardiovascular death, target vessel MI and idTLR (TLF) at 1-year FU will be evaluated (safety endpoint - superiority). 4) Bleeding BARC 2 or greater - Others: * Composite of cardiovascular death, target vessel MI and idTLR (TLF) at 2 years. * Occurrence of cardiovascular death and target-vessel myocardial infarction (MI) at 2 years. * All-cause mortality up to 2 years from procedure. * Stroke up to 2 years from procedure. * Stent thrombosis (defined for grade and timing according to the Academic Research Consortium2). * Technical success. * Clinical procedural success. * Occurrence of idTLR at 2-year FU. * Target vessel revascularization (TVR) up to 2 years. | — |
Countries
Netherlands
Outcome results
None listed