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Completed

NCT Number: NCT03806621

Rota China Registry

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of USTC, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rotational atherectomy

Procedure

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

Primary outcomes

  1. Major adverse cardiovascular event (MACE) (primary safety endpoint)

    Time frame: 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)

  2. Procedural success rate (primary efficacy endpoint)

    Time frame: 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 outcomes

  1. TLR rate

    Time frame: At 30 days and 12 months post-index procedure

  2. Target lesion failure (TLF) rate

    Time frame: At 30 days and 12 months post-index procedure

  3. TVR rate

    Time frame: At 30 days and 12 months post-index procedure

  4. Target vessel failure (TVF) rate

    Time frame: At 30 days and 12 months post-index procedure

  5. MI rate

    Time frame: At 30 days and 12 months post-index procedure

  6. Cardiac death rate

    Time frame: At 30 days and 12 months post-index procedure

  7. Non-cardiac death rate

    Time frame: At 30 days and 12 months post-index procedure

  8. All-cause death rate

    Time frame: At 30 days and 12 months post-index procedure

  9. Cardiac death or MI rate

    Time frame: At 30 days and 12 months post-index procedure

  10. All-cause death or MI rate

    Time frame: At 30 days and 12 months post-index procedure

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

    Time frame: At 30 days and 12 months post-index procedure

  12. Stent thrombosis (ST) rate

    Time frame: At 30 days and 12 months post-index procedure

  13. Subgroup analyses of MACE

    Time frame: At 30 days and 12 months post-index procedure

    • 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

Other outcomes

  1. Rate of arterial perforation (rotational atherectomy related or non-related)

    Time frame: Peri-procedural

  2. Rate of abrupt coronary occlusion (including dissection and thrombosis)

    Time frame: Peri-procedural

  3. Rate of significant coronary dissection (NHLBI types C-F)

    Time frame: Peri-procedural

  4. Rate of consistent no reflow

    Time frame: Peri-procedural

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Collaborators

  • BSC International Medical Trading (Shanghai) Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jan 16, 2019
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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