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ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)

NCT04742478 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2021-04-23

No results posted yet for this study

Summary

Rotablation with or without other calcium debulking therapies is a safe adjunctive procedure for patients with severe coronary calcification requiring Percutaneous Coronary Intervention (PCI).

Conditions

  • Coronary Artery Calcification

Interventions

PROCEDURE

Rotational Atherectomy

Rotational atherectomy (RA) has been the most used atherectomy modality since its first inception in1988. RA uses high speed rotation (140,000 - 180,000 rpm) to ablate inelastic plaque, resulting in debris averaging 5µm in size24. The main focus of RA in the era of DES stent has been on plaque modification rather that plaque debulking with more papers showing improved PCI success rates.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • National Heart Centre Singapore

    lead OTHER

Principal Investigators

  • Khung Keong Yeo · Singhealth Foundation

  • Shoichi Kuramitsu · Kokura Memorial Hospital

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2024-02-29
Completion
2026-12-31

Countries

  • Japan
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742478 on ClinicalTrials.gov