Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04742478
Status:
RECRUITING
Last Update Posted:
2021-04-23
First Post:
2021-02-02
Brief Title:
ROVUS Asia Registry Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion
Sponsor:
National Heart Centre Singapore
Organization:
National Heart Centre Singapore
Study Overview
Official Title:
ROVUS Asia Registry Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion
Status:
RECRUITING
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROVUS
Brief 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
Detailed Description:
This is a prospective observational multicenter cohort study of all patients with calcified coronary lesions undergoing RA in participating centres across Asia Patients will be required to provide informed consent for data collection including follow-up data and uploading of data on a web-based data collection platform deidentified Operators institution coordinators will fill up hardcopy or electronic web-based forms including patients baseline demographics co-morbidities clinical data laboratory test results echocardiography results coronary angiography findings with subsequent interventions performed as well as follow-up clinical and laboratory results Note that while detailed data for individual patients will only be collected if there is informed consent data from each institution will also be collected for aggregate data regarding procedural volume eg total cases with debulking therapy and specifically for ROTABLATORTM This will give a sense of representativeness of data collected This screening data will also include the following fields age gender ethnicity comorbidities target vessel prior revascularization PCICABG clinical presentation procedural urgency angiographic procedural details RA and PCI and in-hospital complication and mortality The use of this retrospective data will require appropriate approval and will only utilize anonymized data Only in-hospital data will be obtained and no follow up data is required from these controls Should these data not be available in any of the participating sites a minimum baseline demographics procedural and inpatient outcome data with reasons for non-participation in registry should be provided for records purposes This shall be accepted as a limitation of the study Sub-site analysis may be performed in centres with availability of all data in this group of patients to address generalisability of the data collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None