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| Name | Class |
|---|---|
| BSC International Medical Trading (Shanghai) Co., Ltd. | OTHER |
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Rotational atherectomy (RA) facilitates percutaneous coronary intervention for complex de novo lesions with severe calcification. Some observational studies and a small randomized trial indicated that a strategy of routine RA did not conferred reduction in restenosis or MACE, but these studies are limited by missing follow-up, insufficient power to compare outcomes, and confounding factors in the RA group (long lesion length, etc.). With recent developments in medical therapy, advances in design and delivery of drug-eluting stents (DES), and advances in noninvasive and intravascular coronary imaging, the use of RA in current real-world practice remains to be well determined. We aimed to compile real-world clinical outcomes data for the RotablatorTM Rotational Atherectomy System in routine clinical practice in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotational Atherectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotational Atherectomy | Procedure | Patients with severe calcified lesions will receive rotational atherectomy during index PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular event (MACE) (primary safety endpoint) | The composite of any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI), or cardiac death. Periprocedural myocardial infarction, defined as in patients with normal baseline CK-MB, the peak CK-MB measured within 48 hours of the procedure rises to ≥ 10 x the local laboratory ULN, or to ≥ 5 x ULN with new pathologic Q-waves in ≥ 2 contiguous leads or new persistent LBBB (according to SCAI definition. J Am Coll Cardiol 2013;62:1563-70) | 30 days |
| Procedural success rate (primary efficacy endpoint) | A mean lesion diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, target vessel revascularization (TVR), or cardiac death | Peri-procedural |
| Measure | Description | Time Frame |
|---|---|---|
| TLR rate | At 30 days and 12 months post-index procedure | |
| Target lesion failure (TLF) rate | At 30 days and 12 months post-index procedure | |
| TVR rate |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of arterial perforation (rotational atherectomy related or non-related) | Peri-procedural | |
| Rate of abrupt coronary occlusion (including dissection and thrombosis) | Peri-procedural | |
Inclusion Criteria:
Age ≥18 years old
Subject who is clinically indicated for PCI/stenting
Written informed consent
Subject is willing to comply with all protocol-required follow-up evaluation
Subject must meet one of following angiographic/procedural inclusion criteria:
Exclusion Criteria:
Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI within 2 weeks
Subject has any of the following angiographic findings:
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This national, multi-center, prospective, observational study will enroll at least 1000 subjects in about 18 to 20 sites in China. All subjects who are candidates for PCI, signed the informed consent form and eligible to receive the treatment using RotablatorTM Rotational Atherectomy System will be evaluated for enrollment in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC | Hefei | Anhui | China | |||
| Beijing Anzhen Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39223992 | Derived | Wang X, Zhang H, Bai X, Zhang L, Li C, Mao X, Chen J, Luo J, Zhao Y, Zhou B, You B, Zhang Y, Ma L, Du Z, Chen Y, Sun F, Qiu C, Shen Z, Wen S, Mintz GS, Ye F, Nie S; China Rota Elite Group. Practices and outcomes of rotational atherectomy in China: The Rota China registry. Catheter Cardiovasc Interv. 2024 Oct;104(4):664-675. doi: 10.1002/ccd.31211. Epub 2024 Sep 3. |
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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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| At 30 days and 12 months post-index procedure |
| Target vessel failure (TVF) rate | At 30 days and 12 months post-index procedure |
| MI rate | At 30 days and 12 months post-index procedure |
| Cardiac death rate | At 30 days and 12 months post-index procedure |
| Non-cardiac death rate | At 30 days and 12 months post-index procedure |
| All-cause death rate | At 30 days and 12 months post-index procedure |
| Cardiac death or MI rate | At 30 days and 12 months post-index procedure |
| All-cause death or MI rate | At 30 days and 12 months post-index procedure |
| All-cause death, MI, or TVR rate | At 30 days and 12 months post-index procedure |
| Stent thrombosis (ST) rate | At 30 days and 12 months post-index procedure |
| Subgroup analyses of MACE | 1. Age (< 65 years vs. ≥ 65 years), 2. Female, 3. Hypertension, 4. Diabetes, 5. CKD, 6. Left ventricular ejection fraction (≤ 50% vs. > 50%), 7. LM lesion, 8. Long lesion, 9. CTO, 10. Bifurcation lesion, 11. Speed of rotation, 12. Maximal burr size, 13. IVUS or OCT use | At 30 days and 12 months post-index procedure |
| Rate of significant coronary dissection (NHLBI types C-F) |
| Peri-procedural |
| Rate of consistent no reflow | Peri-procedural |
| Beijing |
| Beijing Municipality |
| 100029 |
| China |
| Beijing Hospital | Beijing | Beijing Municipality | China |
| Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
| Guangdong Provincial People's Hospital, Guangdong Academy of Medical Science | Guangzhou | Guangdong | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| Fuwai Central China Cardiovascular Hospital | Zhengzhou | Henan | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China |
| Nanjing First hospital, Nanjing Medical University | Nanjing | Jiangsu | China |
| First Hospital of China Medical University | Shenyang | Liaoning | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | China |
| Xijing Hospital, the Fourth Military Medical University | Xi'an | Shaanxi | China |
| Qilu Hospital (Qingdao), Shandong University | Jinan | Shandong | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | China |
| Tianjin Fourth Central Hospital | Tianjin | Tianjin Municipality | China |
| The First People's Hospital of Yunnan Province | Kunming | Yunnan | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| 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 |