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Coronary Artery DiseaseNCT03806621

Rota China Registry

An observational study of Coronary Artery Disease, run by Beijing Anzhen Hospital at 19 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Rotational Atherectomy
Type of treatment
Surgery or procedure
How many people
980 participants
Where
19 sitesChina
Study dates
18 Jul 2018to 20 Jan 2022
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029

  • Beijing Hospital

    Beijing, Beijing Municipality

  • Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • Guangdong Provincial People's Hospital, Guangdong Academy of Medical Science

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The First Affiliated Hospital of USTC

    Hefei, Anhui

  • Qilu Hospital (Qingdao), Shandong University

    Jinan, Shandong

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan

  • Nanjing First hospital, Nanjing Medical University

    Nanjing, Jiangsu

  • First Hospital of China Medical University

    Shenyang, Liaoning

  • Tianjin Fourth Central Hospital

    Tianjin, Tianjin Municipality

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

  • Xijing Hospital, the Fourth Military Medical University

    Xi'an, Shaanxi

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Post-Approval Study of the RotablatorTM Rotational Atherectomy System in China

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.

Being tested
Rotational Atherectomy
Keywords
coronary artery disease, percutaneous coronary intervention, rotational atherectomy
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rotational AtherectomyProcedure or surgery

    Patients with severe calcified lesions will receive rotational atherectomy during index PCI

Study groups in NCT03806621
Study groupRoleWhat they receive
Rotational AtherectomyNot described
Receives: Procedure: Rotational Atherectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 30 days

  2. 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

    Measured: Peri-procedural

Secondary outcomes (13)

  1. TLR rate

    Measured: At 30 days and 12 months post-index procedure

  2. Target lesion failure (TLF) rate

    Measured: At 30 days and 12 months post-index procedure

  3. TVR rate

    Measured: At 30 days and 12 months post-index procedure

  4. Target vessel failure (TVF) rate

    Measured: At 30 days and 12 months post-index procedure

  5. MI rate

    Measured: At 30 days and 12 months post-index procedure

  6. Cardiac death rate

    Measured: At 30 days and 12 months post-index procedure

  7. Non-cardiac death rate

    Measured: At 30 days and 12 months post-index procedure

  8. All-cause death rate

    Measured: At 30 days and 12 months post-index procedure

  9. Cardiac death or MI rate

    Measured: At 30 days and 12 months post-index procedure

  10. All-cause death or MI rate

    Measured: At 30 days and 12 months post-index procedure

  11. All-cause death, MI, or TVR rate

    Measured: At 30 days and 12 months post-index procedure

  12. Stent thrombosis (ST) rate

    Measured: At 30 days and 12 months post-index procedure

  13. 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

    Measured: At 30 days and 12 months post-index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2019
  2. Study start18 Jul 2018
  3. Primary completion27 Dec 2020
  4. Study completion20 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
980 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03806621
Sponsor's protocol ID
2017033
Status last verified
Aug 2023
First submitted
12 Dec 2018
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39223992

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Beijing Anzhen Hospital at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiovascular event (MACE) (primary safety endpoint) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03806621, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.

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