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The aim of the present observational study is to collect clinical data on the non-implantable medical device INVADER™ PTCA in the daily use in an unselected population.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVADER™ PTCA Balloon Dilatation Catheter | Device | INVADER™ PTCA Balloon Dilatation Catheter is a single use, EO sterilized, monorail rapid exchange (RX) coronary angioplasty balloon dilatation catheter. The INVADER™ PTCA has been designed to dilate the stenotic atherosclerotic lesions in coronary arteries or bypass grafts. The INVADER™ PTCA is an interventional, non-surgical device, and considered minimally invasive. |
| Measure | Description | Time Frame |
|---|---|---|
| Device success | Measurement: Percentage of lesions among all attempted lesions with:
| 48 hours after index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of individual components of device success | 48 hours after index procedure | |
| Procedural success: | o Measurement: Percentage of device success without major adverse cardiovascular events (MACE) (composite of all death, myocardial infarction [MI], and clinically indicated target lesion revascularization [CI-TLR]). |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consisted of all consecutive patients treated with the INVADER™ PTCA at the study sites: all patients who met the inclusion/exclusion criteria were enrolled
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alvimedica | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| 48 hours after index procedure |
| Rate of Target Lesion Failure (TLF) | o Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR. | 48 hours after index procedure |
| D001157 |
| Arterial Occlusive Diseases |