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| Name | Class |
|---|---|
| SIS Medical AG | INDUSTRY |
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The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty in an angiographically well-defined group of patients with severely calcified coronary lesions (grade 3) undergoing coronary stent implantation (SYNERGY everolimus-eluting stent (EES)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPN NC | Experimental | Patients receiving a Super High-Pressure NC PTCA Balloon (OPN NC) |
|
| NSE Alpha | Experimental | Patients receiving a Scoring PTCA Balloon (NSE Alpha) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Super High-Pressure NC PTCA Balloon (OPN NC) | Device | Strategy of Super High-Pressure NC PTCA Balloon (OPN NC) after unsuccessful lesion preparation with conventional NC balloon angioplasty. |
| Measure | Description | Time Frame |
|---|---|---|
| Stent expansion index (SEI) | Stent expansion index (SEI), defined as minimum stent area divided by mean reference area in an optical coherence tomography (OCT) quantitative analysis | intraprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic Success | 'Angiographic Success', defined as the achievement of residual angiographic stenosis <30% of the target lesion in the presence of TIMI 3 flow | intraprocedural |
| Procedural Success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert A Byrne, MD BCh PhD | Deutsches Herzzentrum Muenchen | Study Chair |
| Salvatore Cassese, MD PhD | Deutsches Herzzentrum Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Herzzentrum Freiburg Bad Krozingen | Bad Krozingen | Germany | ||||
| Segeberger Kliniken GmbH |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Scoring PTCA Balloon (NSE Alpha) | Device | Strategy of Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty. |
|
'Procedural Success', defined as the achievement of angiographic success without any MACE, defined as cardiac death, target vessel related myocardial infarction and repeat revascularization (PTCA/PCI or coronary artery bypass graft [CABG])
| 30 days |
| Strategy Success | 'Strategy Success' defined as procedural success using the assigned study device and stent, without requirement for lesion preparations with further devices (i.e. rotational atherectomy [RA]) | intraprocedural |
| Acute lumen gain, | Acute lumen gain, defined as minimal lumen diameter (MLD) post balloon angioplasty minus baseline MLD (mm) | intraprocedural |
| Complementary lesion preparations | Number of complementary lesion preparations with further devices (i.e. rotational atherectomy [RA]) | intraprocedural |
| Rate of vessel perforation | Rate of vessel perforation | intraprocedural |
| Procedure duration | Procedure duration in min | intraprocedural |
| Contrast volume | Contrast volume in mL | intraprocedural |
| Bad Segeberg |
| Germany |
| Herzzentrum Leipzig | Leipzig | Germany |
| Deutsches Herzzentrum Muenchen | München | Germany |
| Luzerner Kantonsspital | Lucerne | Switzerland |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |