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The purpose of this study is to collect and analyze additional information about the safety and effectiveness of the Presillion™ Stent System in the treatment of de novo stenotic lesions in native coronary arteries.
This is a post market, non-randomized, multi-center, prospective, single arm clinical study that will be conducted at up to 25 sites in Europe and Israel. All patients will be followed at 30 days, 6 months, 9 months and 1 year post index stenting procedure.
The primary endpoint will be the incidence of target vessel failure (TVF, see definition below) within 270 days of treatment with the Presillion™ Stent System. This rate will be compared with a performance goal derived using a meta-analysis of the standard-of-care therapy, coronary stenting with bare metal stents. This data will be used to support the PMA application for the Presillion™ Stent System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Presillion™ Stent System | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheterization, stent deployment | Device | Standard catheterization procedure including Bare Metal Stent deployment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target vessel failure (TVF) | 270 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Middelheim | Antwerp | 2020 | Belgium | |||
| UZ Brussel |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D002404 | Catheterization |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Brussels |
| 1090 |
| Belgium |
| CHU Charleroi | Charleroi | 6000 | Belgium |
| CHU de Liege | Liège | 4000 | Belgium |
| Herz-Kreislauf-Zentrum Segeberger Kliniken | Bad Segeberg | D-23795 | Germany |
| Charité - Campus Benjamin Franklin | Berlin | 12203 | Germany |
| CardioVascular Center Frankfurt Sankt Katharinen | Frankfurt | 60389 | Germany |
| University Hospital of Heidelberg | Heidelberg | 69120 | Germany |
| Helios Klinkum | Siegburg | 53721 | Germany |
| Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH | Villingen-Schwenningen | D 78050 | Germany |
| EMEK Medical Center | Afula | 18101 | Israel |
| Hadassah Medical Organization | Jerusalem | 91120 | Israel |
| Sanz Medical Center, Laniado Hospital | Netanya | 42150 | Israel |
| Assaf Harofeh Medical Center | Ẕerifin | 70300 | Israel |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| Lund University Hospital | Lund | Sweden |