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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• Able to understand and sign an informed consent form

• Presence of clinical indication for percutaneous coronary intervention (PCI) and/or stent placement

• Subjects willing to comply with all research and follow-up requirements.

• Angiographic criteria (ONE of the following criteria MUST be met)

‣ Target lesions visually have at least moderate calcifications\*

⁃ Target lesion balloon dilatation failure

⁃ Inability of devices (microcatheters, balloons or stents) to pass through the target lesion.

• Procedural criteria

‣ All patients treated with RA with or without other forms of debulking therapy

∙ Moderate calcification is defined as radio-opacities noted only during cardiac cycle prior to contrast injection whereas severe calcification is defined as radio-opacities seen without cardiac motion prior to contrast injection, usually affecting both sides of the arterial lumen.

Locations
Other Locations
Japan
Kokura Memorial hospital
RECRUITING
Kitakyushu
Singapore
National Heart Centre Singapore
RECRUITING
Singapore
Contact Information
Primary
James Low
james.low.j.y@nhcs.com.sg
67042280
Backup
Phoebe Chin
chin.ting.ting@nhcs.com.sg
67042268
Time Frame
Start Date: 2021-03-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 1000
Treatments
Eligible subjects who underwent RA prior to PCI (with informed consent taken to join the study)
Informed consent to be obtained either prior to PCI with rotational atherectomy planned or within 48 hours after rotational atherectomy. There will be data collection of history/demographics, laboratory results, symptoms, any serious adverse events recording for this cohort as well as a telephone follow up at 12months post rotational atherectomy.
Eligible subjects who underwent RA prior to PCI (without informed consent taken to join the study)
Subjects that were demised or refused to give consent will fall under this cohort. The data collection of this cohort will be done through screening of in-hospital data via available local PCI database/registry.
Sponsors
Leads: National Heart Centre Singapore
Collaborators: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov