Coronary Artery Disease
Conditions
Brief summary
A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.
Detailed description
Clinical follow-up visits will take place at 1, 6, and 12 months and annually thereafter until 60 months post procedure. All subjects will undergo an angiographic follow-up at 6- and 12-month follow up. IVUS, (including IVUS-VH documentation) and OCT will be performed for all subjects at 6-month and 12-month follow-up (if the safety of the subject allows it and as per the investigator's decision). Vasomotion will be assessed angiographically with Acetylcholine followed by Nitroglycerine at 12 months follow up in a subgroup of subjects, upon the investigators discretion and if subject consents.
Interventions
Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold
Sponsors
Biotronik AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is \> 18 years and \< 80 years of age 2. Written subject informed consent available prior to PCI 3. Subject eligible for PCI 4. Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions and can be covered with 1 device each 5. Reference vessel diameter between 2.5-4.2 mm by visual estimation, depending on the scaffold size used 6. Target lesion length ≤ 28 mm by visual estimation, depending on the scaffold size used 7. Target lesion stenosis by visual estimation \> 50% - \< 100% and TIMI flow ≥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 9. Eligible for Dual Anti Platelet Therapy (DAPT)
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/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. 3. Left main coronary artery disease 4. Three-vessels with coronary artery disease requiring treatment at time of procedure 5. Planned interventional treatment of any non-target vessel within 12-month post-procedure 6. Subjects on dialysis 7. Planned intervention of the target vessel post index procedure 8. Ostial target lesion (within 5.0 mm of vessel origin) 9. Target lesion involves a side branch \>2.0 mm in diameter 10. Documented left ventricular ejection fraction (LVEF) ≤ 30% within the last 6 months 11. Heavily calcified lesion 12. Target lesion is located in or supplied by an arterial or venous bypass graft 13. Target lesion requiring treatment with a device other than the non-compliant pre-dilatation balloon or scoring balloon prior to scaffold placement (including but not limited to rotational atherectomy, etc.) 14. Unsuccessful pre-dilatation, defined as a residual stenosis rate more than 20%, estimated by any method and/or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections) 15. Known allergies to: Acetylsalicylic Acid (ASA), P2Y12 inhibitors, Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material 16. Subject is receiving an oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has a known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus) diabetes mellitus is not excluded) 17. A stenosis located proximal or distal to the target lesion that might require future revascularization or an impede run off detected during diagnostic angiography 18. Life expectancy less than 1 year 19. Planned surgery or dental surgical procedure within 6 months after index procedure unless DAPT will be maintained 20. In the investigators opinion, subject will not be able to comply with the follow-up requirements 21. Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In scaffold late lumen loss | At 6 months after index procedure | Independent Core Lab Assessment |
Countries
Austria, Belgium, Germany, Netherlands, Poland, Spain, Sweden, Switzerland
Outcome results
None listed