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RECRUITING
NCT04742478

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

Sponsor: National Heart Centre Singapore

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2021-03-10

Completion Date

2026-12-31

Last Updated

2021-04-23

Healthy Volunteers

No

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.

Locations (2)

Kokura Memorial hospital

Kitakyushu, Japan

National Heart Centre Singapore

Singapore, Singapore