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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001481-14 |
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| Name | Class |
|---|---|
| Acrostak | INDUSTRY |
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The aim of the study is to examine the efficacy of Paclitaxel injection after a stent implantation in patients with stenosis in native coronary arteries to prevent restenosis in comparision with two admitted therapies.
The aim of the study is to examine whether in patients with stable or instable Angina pectoris and/or documented myocardial ischemia in the presence of de-novo stenosis in native coronary arteries with a degree of stenosis between 50 % and 99 % an additional local administration of paclitaxel after implantation of a conventional stent is superior to the implantation of a conventional stent alone with respect to late lumen loss (LLL). In case of superiority it will be examined whether an additional local administration of paclitaxel after implantation of a conventional stent is not inferior to the implantation of a paclitaxel-eluting stent with respect to late lumen-luss. Is this the case, superiority will be tested.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| local intracoronary dosis of Paclitaxel | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is the angiographical determination of the late lumen loss in the stent and/or persistent area, 6 month after stent implantation. | week 26 +/- 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| The angiographical determination of the binary restenosis rate, defined as diameter stenosis of at least 50 % in the stent and / or persistent area, 6 months after stent implantation. | week 26 +/- 14 days | |
| The angiographical determination of the degree of stenosis, defined as percentage diameter stenosis in the stent and /or persistent area, 6 months after stent implantation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Herdeg, PD | Universitätsklinikum Tübingen, Medizinische Universitäts und Poliklinik III, Abteilung Kardiologie und Kreislauferkrankungen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abteilung Kardiologie und Kreislauferkrankungen, Medizinische Universitätsklinik und Poliklinik III, Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20031731 | Derived | Herdeg C, Gohring-Frischholz K, Haase KK, Geisler T, Zurn C, Hartmann U, Wohrle J, Nusser T, Dippon J, May AE, Gawaz M. Catheter-based delivery of fluid paclitaxel for prevention of restenosis in native coronary artery lesions after stent implantation. Circ Cardiovasc Interv. 2009 Aug;2(4):294-301. doi: 10.1161/CIRCINTERVENTIONS.108.827865.108.827865. Epub 2009 Jul 22. |
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| week 26, +/- 14 days |
| Tthe angiographical determination of the minimal lumen diameter in the stent and / or persistent area, 6 months after stent implantation. | week 26, +/- 14 days |
| The 6 months after stent implantation determined combined endpoint of abrupt and subabrupt closure of the target vessel, target lesion revascularisation and major adverse cardiac events including myocardial infarction and death. | week 26, +/-14 days |
| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| 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 |
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