coronary stenosis- narrowing of the vessels (arteries) wich supply the hear with blood
Conditions
Interventions
Percutaneous transluminal coronary angioplasty (PTCA) including concomitant
anticoagulation medication according to protocol and implantation of the DREAMS
3G scaffold
Sponsors
BIOTRONIK AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is > 18 years and 50% - =1 (assisted by e.g. QCA / IVUS /FFR). 8. Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients without angiographic evidence of thrombus at target lesion NOTE: patient with acute STEMI can not be included in the study (according to exclusion criteria 2) 9. Subject who has no contraindication for.Dual Anti Platelet Therapy (DAPT)
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study 2. Subject has clinical symptoms and electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. NOTE: after 72 hours, any lesion other than the one causing the acute STEMI (culprit lesion) in any other epicardial vessel, may be treated according to the inclusion and exclusion criteria 3. Left main coronary artery disease 4. Three-vessels with coronary artery disease requiring treatment at time of procedure, including: left main, left anterior descending artery (LAD) right coronary artery (RCA) and circumflex coronary artery (Cx) 5. Planned interventional treatment of any non-target vessel within 12-month post-procedure 6. Subjects on dialysis 7. Impaired renal function (serum creatinine > 2.5 mg/dl or 221 µmol/l, determined within 72 hours prior to intervention) 8. Planned future intervention of a second lesion within the target vessel. 9. Ostial target lesion (within 5.0 mm of vessel origin) 10.Target lesion involves a side branch >2.0 mm in diameter 11.Documented left ventricular ejection fraction (LVEF)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be in-scaffold late lumen loss (LLL) at 6-month post-procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical * Target Lesion Failure (TLF*) at 1, 6, 12 months and annually thereafter until 60 months post procedure * Cardiac death at 1, 6, 12 months and annually thereafter until 60 months post procedure * Target vessel MI at 1, 6, 12 months and annually thereafter until 36 months post procedure** * Clinically driven target lesion revascularization at 1, 6, 12 months and annually thereafter until 60 months post procedure * Clinically driven target vessel revascularization at 1, 6, 12 months and annually thereafter until 60 months post procedure * Definite and probable scaffold thrombosis rate at 1, 6, 12 months and annually thereafter until 60 months post procedure (according to ARC-2 definition) * Procedure success: achievement of a final diameter stenosis of | — |
Countries
Netherlands
Outcome results
None listed