Coronary Artery Disease
Conditions
Keywords
Coronary artery disease, Atherosclerosis, CAD
Brief summary
This study evaluates the safety and effectiveness of the Momo Cobalt Chromium stent system for the treatment of single de novo lesions in a native coronary artery. The stent is coated with diamond-like carbon to decrease the risk of acute and late stent thrombosis, to increase the resistance towards corrosion and to significantly improve endothelialisation through the inhibition of elution of metallic ions.
Interventions
DEVICEMomo stent
Patients with PCI
Sponsors
Japan Stent Technology Europe GmbH
be Medical
Study design
Allocation
NA
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. Patients with stable angina pectoris (Canadian Cardiovascular Society \[CCS\] I to IV) or unstable angina pectoris (Braunwald classification IB-C, IIB-C or IIIB-C) or patients with documented silent ischemia. 2. Patients who are eligible for coronary revascularization by angioplasty and stenting and by CABG (if required as bail-out). 3. Patients with a de novo lesion in a native coronary artery between \> 50 % and \< 100 % stenosis. 4. One or two heart vessel disease with a maximum of 2 lesions to be treated by stenting. Both lesions have to be treated with study stents. 5. Target vessel suitable for implantation of a single stent with a target vessel diameter of ≥ 2.5 mm and lesion length \< 20 mm. 6. Patients with left ventricular ejection fraction (LVEF) of \> 30 %. 7. Patients willing to sign a written informed consent prior to participation and willing to be compliant with all requested follow-up evaluations.
Exclusion criteria
1. Patients under the age of 18 or unable to give informed consent. 2. Women of child bearing potential. 3. Patients who currently participate in another study (whatever the subject of that study is). 4. Patients who participated in another investigational cardiovascular drug or device study, which have not completed the primary endpoint follow-up period within the past 30 days. 5. Patients with a life expectancy of less than 24 months or factors making clinical and/or angiographic follow-up difficult (no fixed address, etc.). 6. Patients who intend to have a major (as per principal investigators' medical judgment) surgical intervention within 6 months of enrolment in the study. 7. Patients with an episode of sustained ischemic chest pain exceeding 15 minutes duration within 24 hours prior to stenting or patients with new ST elevation within 48 hours prior to stenting. 8. Patients with a contraindication to emergency coronary bypass surgery. 9. Any individual who may refuse a blood transfusion. 10. Patients with serum creatinine \> 2.0 mg/dl or (\> 180 µmol/l). 11. Patients with a baseline platelet count less than 100,000 platelets/mm³. 12. Patients with intolerance or contraindication to acetylsalicylic acid (aspirin), heparin, clopidogrel or ticlopidine drug therapy. 13. Patients with contrast agent hypersensitivity that cannot be adequately pre-medicated. 14. Patients whose target vessel has been stented before. 15. Any procedure to treat another coronary artery scheduled within 6 months after implantation of the study stent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month angiography | 6 months | Binary restenosis(defined as \>50% diameter stenosis by QCA), late loss, percent diameter stenosis, minimal lumen diameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events | 6 months | including death, recurrent non-fatal myocardial infarction, emergent CABG and/or clinically driven target vessel revascularization |
| MACE | 1 month, 6 months, 12 months | Including death, recurrent non-fatal myocardial infarction, emergent CABG and/or clinically driven target vessel revascularization, target lesion revascularization (TLR), target vessel revascularization (TVR), target vessel failure (TVF) and stent thrombosis |
Countries
Belgium
Contacts
Primary ContactLuc Janssens, MD
Outcome results
None listed