Coronary Artery Disease
Conditions
Keywords
PTCA, stenosis, sirolimus, stent
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the eucaLimus Sirolimus Eluting stent system in patients with de novo coronary lesions.
Interventions
DEVICEeucaLimus
Percutaneous Coronary Intervention (PCI)
Sponsors
CERES GmbH
Eucatech AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥18 years or the minimum age required for legal adult consent in the country of enrollment. 2. Subject is an acceptable candidate for Percutaneous Coronary Intervention (PCI). 3. Subject is an acceptable candidate for Emergent Coronary Artery Bypass Grafting (CABG). 4. Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia. 5. Subject is eligible for dual anti-platelet therapy treatment with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine. 6. Subject has provided written informed consent. 7. Subject is willing to comply with study follow-up requirements. Each target lesion/vessel must meet all of the following angiographic criteria for the subject to be eligible for the trial: 1. Subject has up to 3 target lesions in up to 3 separate target vessels Subject has up to 3 target lesions in in up 2 separate target vessels (2 target lesions in 1 vessel and 1 target lesion in a separate vessel). Subject has 1 target lesions in 1 vessel. 2. Target lesion must be de novo. 3. Target lesion must be in major coronary artery or branch (target vessel). 4. Target lesion must have angiographic evidence of ≥ 50% and \< 100% stenosis (by operator visual estimate) 5. Target lesion must be ≤ 35 mm in length by operator visual estimate. 6. Target vessel Reference Vessel Diameter (RVD) of 2.25mm - 4.00mm by operator visual estimate. 7. Target lesion must be treatable with a maximum of 1 stents
Exclusion criteria
1. 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. Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment. 2. Subject is presenting cardiogenic shock. 3. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study. 4. Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), Polylactic-Co-Glycolic Acid (PLGA), sirolimus 5. Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 30 days prior to the index procedure. 6. Planned treatment of a lesion not meeting angiographic inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lumen Revascularisation (TLR) | 12 months post procedure | Clinical driven TLR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Lumen Revascularisation (TLR) | 1 month, 6 months, 24 months post procedure | Clinical driven TLR |
| Composite of cardiac death | 1 month, 6 months, 12 months, 24 months post procedure | MI attributed to the target vessel and clinically driven target lesion revascularization |
| Composite of all-cause mortality | 24 months post procedure | any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels |
| Stent thrombosis | 1 month, 6 months, 12 months, 24 months post procedure | — |
Contacts
Primary ContactMichael Giese, Dr.
Backup ContactAlexander Karl, Dipl.-Ing.
Outcome results
None listed