Rota China Registry
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: Rotational Atherectomy
- Registration Number
- NCT03806621
- Lead Sponsor
- Beijing Anzhen Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 980
-
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:
- Target lesion is moderately to severely calcified by visual estimate
- Unsuccessful balloon dilatation of the target lesion
- Unsuccessful passage of device(s) (microcatheter, balloon, or stent) across the target lesion
-
Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI within 2 weeks
-
Subject has any of the following angiographic findings:
- Thrombus present in the target vessel (by visual estimate)
- Significant dissection present in the target vessel (NHLBI types C-F)
- Lesion angulation > 60°(by visual estimate)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Rotational Atherectomy Rotational Atherectomy -
- Primary Outcome Measures
Name Time Method Major adverse cardiovascular event (MACE) (primary safety endpoint) 30 days 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)
Procedural success rate (primary efficacy endpoint) Peri-procedural 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
- Secondary Outcome Measures
Name Time Method Target lesion failure (TLF) rate At 30 days and 12 months post-index procedure TLR rate At 30 days and 12 months post-index procedure Target vessel failure (TVF) rate At 30 days and 12 months post-index procedure TVR rate At 30 days and 12 months post-index procedure 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 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 MI rate At 30 days and 12 months post-index procedure Cardiac death or MI rate At 30 days and 12 months post-index procedure Subgroup analyses of MACE At 30 days and 12 months post-index procedure 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
Non-cardiac death rate At 30 days and 12 months post-index procedure
Trial Locations
- Locations (19)
The First Affiliated Hospital of USTC
🇨🇳Hefei, Anhui, China
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, 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
First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Nanjing First hospital, Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Qilu Hospital (Qingdao), Shandong University
🇨🇳Jinan, Shandong, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Fourth Central Hospital
🇨🇳Tianjin, Tianjin, 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
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
Xijing Hospital, the Fourth Military Medical University
🇨🇳Xi'an, Shaanxi, China