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Aim Primary percutaneous coronary intervention efficacy improvement by DIVER CE thrombectomy system leading to thrombus reduction.
Study design:
Multicenter, prospective, opened, randomized.
Primary endpoints:
ST resolution >70% 60 minutes after PCI
Secondary endpoints:
Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale ≥ 1 TIMI 3 flow after PCI MBG 3 CMR - infarct size, measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF) ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI) Major cardiac events /cardiac death, reMI, rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up Rate of composite angiographic adverse events including: distal embolisation, transient no-reflow or slow flow, final TIMI <3, need of bail out GpIIb/IIIa inhibitors or adenosine or nitroprosside, final thrombus score >1
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous thrombectomy | Device |
| Measure | Description | Time Frame |
|---|---|---|
| ST resolution >70% 60 minutes after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale ≥ 1 | ||
| TIMI 3 flow after PCI | ||
| MBG 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dariusz Dudek, MD | Contact | 124247181 | +48 | mcdudek@cyf-kr.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Dariusz Dudek, MD | Jagiellonian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute, Medical School of University Pecs | Recruiting | Pécs | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21095287 | Derived | Dudek D, Mielecki W, Burzotta F, Gasior M, Witkowski A, Horvath IG, Legutko J, Ochala A, Rubartelli P, Wojdyla RM, Siudak Z, Buchta P, Pregowski J, Aradi D, Machnik A, Hawranek M, Rakowski T, Dziewierz A, Zmudka K. Thrombus aspiration followed by direct stenting: a novel strategy of primary percutaneous coronary intervention in ST-segment elevation myocardial infarction. Results of the Polish-Italian-Hungarian RAndomized ThrombEctomy Trial (PIHRATE Trial). Am Heart J. 2010 Nov;160(5):966-72. doi: 10.1016/j.ahj.2010.07.024. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017131 | Thrombectomy |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| CMR - infarct size, measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF) |
| ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI) |
| Major cardiac events /cardiac death, reMI, rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up |
| Rate of composite angiographic adverse events including: distal embolisation, transient no-reflow or slow flow, final TIMI <3, need of bail out GpIIb/IIIa inhibitors or adenosine or nitroprosside, final thrombus score >1 |
| Cardiology Department Hospital Villascassi | Recruiting | Genova | Italy |
|
| Institute of Cardiology, Catholic University | Recruiting | Rome | Italy |
|
| Górnośląskie Centrum Medyczne | Recruiting | Katowice | Poland |
|
| Zaklad Hemodynamiki i Angiokardiohrafii IK CMUJ | Recruiting | Krakow | 31-501 | Poland |
|
| Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ | Recruiting | Nowy Sącz | Poland |
|
| Szpital Wojewódzki w Przemyślu | Recruiting | Przemyśl | Poland |
|
| Instytut Kardiologii im.Prymasa Tysiaclecia Sefana Kardynala Wyszynskiego | Recruiting | Warsaw | 04-628 | Poland |
|
| Slaskie Centrum Chorob Serca | Recruiting | Zabrze | Poland |
|
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |