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| Name | Class |
|---|---|
| KCRI | OTHER |
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To evaluate the safety and effectiveness of the ALEX stent in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.
Prospective, multicenter, non-randomized study designed to enroll up to 60 subjects to evaluate the safety and effectiveness of the cobalt-chromium sirolimus eluting coronary stent ALEX in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALEX stent arm | Experimental | implantation of ALEX stent during index procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation | Procedure | index angioplasty with ALEX stent implatation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of stent strut coverage and parameters of restenosis | Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) 12 months follow-up after the baseline procedure in group of first 20 patients | at 12 months follow-up |
| Assessment of stent strut coverage and parameters of restenosis | Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) 6 months follow-up after the baseline procedure in group of second 20 patients | at 6 months follow-up |
| Assessment of stent strut coverage and parameters of restenosis | Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) at 3 months follow-up after the baseline procedure in group of third 20 patients | at 3 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | Procedural success during baseline PCI assessed in coronary angiography (QCA) | during index hospitalization |
| Occurrence of stent thrombosis | Occurrence of stent thrombosis at 30 days follow-up |
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Inclusion Criteria:
Clinical Inclusion Criteria:
Angiographic Inclusion Criteria
Exclusion Criteria:
Clinical Exclusion Criteria
Angiographic Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jacek Legutko, MD, PhD | Szpital Uniwersytecki w Krakowie, ul. Kopernika 17, Krakow 31-501, Poland | Principal Investigator |
| Dariusz Dudek, Prof. | Szpital Uniwersytecki w Krakowie, ul. Kopernika 17, Krakow 31-501, Poland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carint Scanmed Szpital Sw. Rafala | Krakow | Bochenka 12 | 30-693 | Poland | ||
| Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Zakladu Hemodynamiki i Angiografii |
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| at 30 days follow-up |
| Occurrence of stent thrombosis | Occurrence of stent thrombosis at 12 months follow-up | at 12 months follow-up |
| Incidence of Major Adverse Cardiac Events | Incidence of Major Adverse Cardiac Events (MACEs) at 30 days follow-up defined as death, myocardial infarction target lesion re-PTCA or target lesion bypass graft | at 30 days follow-up |
| Incidence of Major Adverse Cardiac Events | Incidence of Major Adverse Cardiac Events (MACEs) at 12 months follow-up defined as death, myocardial infarction target lesion re-PTCA or target lesion bypass graft | at 12 months follow-up |
| Krakow |
| Kopernika 17 |
| 31-501 |
| Poland |
| Polsko-Amerykanskie Kliniki Serca I Oddzial Kardiologiczno-Angiologiczny | Ustroń | Sanatoryjna 7 | 43-450 | Poland |
| Polsko-Amerykanskie Kliniki Serca III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii | Dąbrowa Górnicza | Szpitalna 13 | 43-300 | Poland |
| Centralny Szpital Kliniczny MSWiA w Warszawie Klinika Kardiologii Inwazyjnej | Warsaw | Woloska 137 | 02-507 | Poland |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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