Coronary Artery Disease
Conditions
Brief summary
Assessment of the safety and clinical performance of a coronary stent system in de novo coronary artery lesions
Interventions
DEVICEStent
Implantation of coronary stent in de novo coronary artery lesions
Sponsors
Biotronik AG
Biotronik CRC Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
consecutive enrolment of cohort 1 (primary endpoint at 1 month), and cohort 2 (primary endpoint at 9 months)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is \> 18 years and \< 85 years old 2. Written subject informed consent 3. Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients 4. Subject is eligible for percutaneous coronary intervention (PCI) 5. Subject is acceptable candidate for coronary artery bypass surgery 6. Subject is eligible for Dual Anti Platelet Therapy (DAPT) 7. Subjects with a maximum of two single discrete de novo lesions in two separate native coronary arteries that can be treated with the study stent during the index procedure 8. Reference vessel diameter of 3.0 mm to 3.8 mm by visual estimation. 9. Target lesion length up to 22 mm by visual estimation. 10. Target lesion with ≥ 50% and \< 100% stenosis by visual estimation
Exclusion criteria
1. Left main coronary artery disease 2. Three-vessel coronary artery disease at the time of index procedure 3. Angiographic evidence of thrombus in target vessel 4. Chronic total occlusion 5. Heavily calcified or extremely tortuous lesions that would prevent complete inflation of a pre-dilatation balloon 6. Bifurcation lesion requiring side branch intervention, if side branches \> 2mm in diameter are involved 7. Ostial lesions (within 5 mm of vessel origin) 8. In-stent restenosis 9. Lesions with prior treatment with a drug coated balloon (DCB) 10. Target lesion is located in or supplied by an arterial or venous bypass graft 11. Target lesion requires treatment with. rotational atherectomy 12. Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography 13. Previous treatment of target vessel within 9 months of index-procedure 14. Patients with cardiogenic shock 15. Documented left ventricular ejection fraction (LVEF) ≤ 30% 16. Impaired renal function (serum creatinine \> 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention) 17. Hemodynamically unstable NSTEMI or STEMI within 72 hours prior to index procedure 18. Cerebrovascular event (within 3 months of index procedure) 19. Subject is receiving oral or intravenous immuno-suppressive therapy (inhaled steroids are allowed) or has known life-limiting immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, but not diabetes mellitus) 20. Known allergies to: Acetylsalicylic Acid (ASA), heparin, contrast medium, sirolimus, or similar drugs, exipients or the stent material 21. Triple anticoagulation therapy 22. Life expectancy less than 1 year 23. Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study 24. Inability to understand or read the informed consent form 25. Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet 26. In the investigators opinion subjects will not be able to comply with the follow-up requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Strut coverage cohort 1 | 1 month | Strut coverage will be assessed by OCT analysis |
| In stent late lumen loss cohort 2 | 9 months | Late lumen loss with will be assessed by central QCA assessment |
Countries
Switzerland
Outcome results
None listed