coronary stenosis narrowing of the vessels (arteries) which supply the heart with blood
Conditions
Interventions
Percutaneous transluminal coronary angioplasty (PTCA) including concomitant
anticoagulation medication according to protocol and implantation of the DREAMS
2G scaffold.
Sponsors
Biotronik
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Subject is > 18 years and 50% -
Exclusion criteria
Exclusion criteria: 1.Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study 2.Evidence of myocardial infarction within 72 hours prior to index procedure 3.Subjects with a *2 fold CK level or in absence of CK a *3 fold CKMB level above the upper range limit within 24 hours prior to the procedure 4.Left main coronary artery disease 5.Three-vessel coronary artery disease at time of procedure 6.Thrombus in target vessel 7.Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet 8.Planned interventional treatment of any non-target vessel within 30 days post-procedure 9.Subject is on dialysis 10.Planned intervention of the target vessel after the index procedure 11.Ostial target lesion (within 5.0 mm of vessel origin) 12.Target lesion involves a side branch >2.0 mm in diameter 13.Documented left ventricular ejection fraction (LVEF) * 30% 14.Heavily calcified lesion 15.Target lesion is located in or supplied by an arterial or venous bypass graft 16.The target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.) 17.Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of DREAMS 2G and angiographic complications (e.g. distal embolization, side branch closure, extensive dissections that can*t be covered by a single scaffold), by visual estimation 18.Known allergies to: Acetylsalicylic Acid (ASA), Heparin, contrast medium, Sirolimus, Everolimus or similar drugs (i.e., ABT 578, Biolimus, Tacrolimus), PLLA, Silicon Carbide, Magnesium, Yttrium, Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum 19.Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l) determined within 72 hours prior to intervention 20.Subject is receiving oral or intravenous immuno-suppressive therapy (inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus) 21.Proximal or distal to the target lesion located stenosis that might require future revascularization or imped run off detected during diagnostic angiography 22.Life expectancy less than 1 year 23.Planned surgery or dental surgical procedure within 6 months after index procedure 24.Subject with tortuous vessel that may impair scaffold placement in the region of obstruction or proximal to the lesion 25.In the investigators opinion subjects will not be able to comply with the follow-up requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is acute performance of the DREAMS 2G assessed by Procedure Success. Procedure Success is defined as achievement of a final diameter stenosis of | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical endpoints: * Target Lesion Failure (TLF*) at 1, 6 12, 24 and 36-months post procedure. * Scaffold thrombosis rate at 1,6, 12, 24 and 36-months (according to ARC definition) * TLF is a composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI)**, Coronary Artery Bypass Grafting (CABG), clinically driven TLR. **Myocardial infarction will be adjudicated according to the Society for Cardiovascular Angiography and Interventions (SCAI) for a definition of Clinically Relevant Myocardial Infarction After Coronary Revascularization (for peri-procedural MIs) Angiographic endpoints: * Binary in-scaffold and in-segment restenosis rate at 12-months * % in-scaffold and in-segment diameter stenosis at 12-months * In-segment Late lumen loss at 12-months * In-scaffold Late lumen loss at 12-months | — |
Countries
Netherlands
Outcome results
None listed