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| Name | Class |
|---|---|
| Japan Stent Technology Europe GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Momo stent | Other | Patients with PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Momo stent | Device | Patients with PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-month angiography | Binary restenosis(defined as >50% diameter stenosis by QCA), late loss, percent diameter stenosis, minimal lumen diameter | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | including death, recurrent non-fatal myocardial infarction, emergent CABG and/or clinically driven target vessel revascularization | 6 months |
| MACE | 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 |
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Inclusion Criteria:
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.
Patients who are eligible for coronary revascularization by angioplasty and stenting and by CABG (if required as bail-out).
Patients with a de novo lesion in a native coronary artery between > 50 % and < 100 % stenosis.
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.
Target vessel suitable for implantation of a single stent with a target vessel diameter of ≥ 2.5 mm and lesion length < 20 mm.
Patients with left ventricular ejection fraction (LVEF) of > 30 %.
Patients willing to sign a written informed consent prior to participation and willing to be compliant with all requested follow-up evaluations.
Exclusion Criteria:
Exclusion criteria related to angiography
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luc Janssens, MD | Contact | +32 15 50 61 91 | Luc.Janssens@imelda.be |
| Name | Affiliation | Role |
|---|---|---|
| Luc Janssens, MD | Imelda vzw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Middelheim | Recruiting | Antwerp | Belgium |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 1 month, 6 months, 12 months |
| Imelda vzw | Recruiting | Bonheiden | Belgium |
|
| AZ Sint Jan | Recruiting | Bruges | Belgium |
|
| UZ Brussel | Recruiting | Brussels | Belgium |
|
| Ziekenhuis Oost-Limburg | Recruiting | Genk | Belgium |
|
| AZ Maria Middelares | Recruiting | Ghent | Belgium |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |