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| Name | Class |
|---|---|
| Else Kröner Fresenius Foundation | OTHER |
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This study compares a new method of treating severely calcified coronary lesions, the intracoronary lithoplasty, with the current gold standard, the rotablation.
Severe coronary calcification is still a challenge for percutaneous coronary intervention (PCI). Reduction of the calcified plaque mass is necessary to achieve adequate stent expansion during further course. Rotablation has been the only reliable option to treat extremely calcified coronary lesions for a long time. Coronary lithoplasty has been recently introduced as a new promising treatment option in this special subset. It provides the unique opportunity to break severely calcified plaque structures even inside deeper layers of the vessel wall. Aim of this study is to compare rotablation and coronary lithotripsy for treatment of severely calcified coronary lesions. Plaque structure, plaque volume, as well as lumen diameters will be analyzed by optical coherence tomography (OCT) before and after debulking, as well as after stent implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotablation | Active Comparator |
| |
| Coronary Lithoplasty | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotablation | Procedure | Percutaneous Coronary Intervention using Rotablation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Stent Area (End of the Procedure) | 0 days |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal/Mean/Maximal Stent Diameter | 0 days | |
| Minimal/Mean/Maximal Lumen area | 0 days | |
| Minimal/Mean/Maximal Lumen diameter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florian Blachutzik, Dr. | University of Giessen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Giessen | Giessen | 35392 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38796321 | Derived | Blachutzik F, Meier S, Blachutzik M, Schlattner S, Gori T, Ullrich-Daub H, Gaede L, Achenbach S, Mollmann H, Chitic B, Aksoy A, Nickenig G, Weferling M, Dorr O, Boeder N, Bayer M, Hamm C, Nef H; ROTA.shock Investigators. Comparison of interventional treatment options for coronary calcified nodules: A sub-analysis of the ROTA.shock trial. Cardiovasc Revasc Med. 2024 Nov;68:37-42. doi: 10.1016/j.carrev.2024.05.030. Epub 2024 May 22. | |
| 37012181 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017225 | Atherectomy, Coronary |
| ID | Term |
|---|---|
| D017073 | Atherectomy |
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
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| Coronary Lithoplasty |
| Procedure |
Percutaneous Coronary Intervention using Lithoplasty |
|
| 0 days |
| Mean/Maximal Stent area | 0 days |
| Incidence of target lesion failure | 0 months; 1 month; 6 months |
| Incidence of target vessel failure | 0 months; 1 month; 6 months |
| MACE rate | 0 months; 1 month; 6 months |
| Derived |
| Blachutzik F, Meier S, Weissner M, Schlattner S, Gori T, Ullrich-Daub H, Gaede L, Achenbach S, Mollmann H, Chitic B, Aksoy A, Nickenig G, Weferling M, Dorr O, Boeder N, Bayer M, Elsasser A, Hamm C, Nef H; ROTA.Shock Investigators. Comparison of Coronary Intravascular Lithotripsy and Rotational Atherectomy in the Modification of Severely Calcified Stenoses. Am J Cardiol. 2023 Jun 15;197:93-100. doi: 10.1016/j.amjcard.2023.02.028. Epub 2023 Apr 2. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009204 |
| Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D062645 | Percutaneous Coronary Intervention |
| D019060 | Minimally Invasive Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D008919 | Investigative Techniques |