Clinical trial NCT03806621: Rota China Registry
Official title: A Post-Approval Study of the RotablatorTM Rotational Atherectomy System in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
percutaneous coronary intervention
rotational atherectomy
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: BSC International Medical Trading (Shanghai) Co., Ltd.
First posted: 2019-01-16
Enrollment: 980
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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:

  * 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

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:

  * 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)

Primary outcomes:
measure: Major adverse cardiovascular event (MACE) (primary safety endpoint)
timeFrame: 30 days
measure: Procedural success rate (primary efficacy endpoint)
timeFrame: Peri-procedural
Secondary outcomes:
measure: TLR rate
timeFrame: At 30 days and 12 months post-index procedure
measure: Target lesion failure (TLF) rate
timeFrame: At 30 days and 12 months post-index procedure
measure: TVR rate
timeFrame: At 30 days and 12 months post-index procedure
measure: Target vessel failure (TVF) rate
timeFrame: At 30 days and 12 months post-index procedure
measure: MI rate
timeFrame: At 30 days and 12 months post-index procedure
measure: Cardiac death rate
timeFrame: At 30 days and 12 months post-index procedure
measure: Non-cardiac death rate
timeFrame: At 30 days and 12 months post-index procedure
measure: All-cause death rate
timeFrame: At 30 days and 12 months post-index procedure
measure: Cardiac death or MI rate
timeFrame: At 30 days and 12 months post-index procedure
measure: All-cause death or MI rate
timeFrame: At 30 days and 12 months post-index procedure
measure: All-cause death, MI, or TVR rate
timeFrame: At 30 days and 12 months post-index procedure
measure: Stent thrombosis (ST) rate
timeFrame: At 30 days and 12 months post-index procedure
measure: Subgroup analyses of MACE
timeFrame: At 30 days and 12 months post-index procedure
Other outcomes:
measure: Rate of arterial perforation (rotational atherectomy related or non-related)
timeFrame: Peri-procedural
measure: Rate of abrupt coronary occlusion (including dissection and thrombosis)
timeFrame: Peri-procedural
measure: Rate of significant coronary dissection (NHLBI types C-F)
timeFrame: Peri-procedural
measure: Rate of consistent no reflow
timeFrame: Peri-procedural
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
state: Anhui
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital, Guangdong Academy of Medical Science
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Nanjing First hospital, Nanjing Medical University
state: Jiangsu
city: Shenyang
country: China
facility: First Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital, the Fourth Military Medical University
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital (Qingdao), Shandong University
state: Shandong
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Fourth Central Hospital
state: Tianjin
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: