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| Name | Class |
|---|---|
| B. Braun Melsungen AG | INDUSTRY |
| Clinical Research Institute Rotenburg a.d.F. | UNKNOWN |
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The aim of the study is to investigate the feasibility of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) followed by bare metal stent (Coroflex ) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 3.8 mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 20 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any Medina classification type in the native left coronary artery as reflected by procedural success and to evaluate the preservation of vessel patency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Eluting Balloon | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug eluting balloon | Device | drug eluting balloon bifurcated coronary lesions single arm study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success (main branch ≤ 30%, side branch ≤ 50%, TIMI Flow 3) | acute |
| Measure | Description | Time Frame |
|---|---|---|
| In-segment late lumen loss at 9 months in either branch | 9 months |
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Inclusion Criteria:
Inclusion Criteria: Lesion Related
Exclusion Criteria:
Exclusion Criteria: Lesion Related
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| Name | Affiliation | Role |
|---|---|---|
| D. G. Mathey, MD | Hamburg University Cardiovascular Center GmbH | Principal Investigator |
| F. X. Kleber, MD | Department of Internal Medicine Unfallkrankenhaus Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| F.X.Kleber | Berlin | 12683 | Germany | |||
| D.G: Mathey |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
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| Hamburg |
| 22527 |
| Germany |