Ignite Creation Date:
2024-05-05 @ 10:03 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01014273
Status:
COMPLETED
Last Update Posted:
2011-04-07
First Post:
2009-11-13
Brief Title:
A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention PCI Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy
Sponsor:
Population Health Research Institute
Organization:
Population Health Research Institute
Study Overview
Official Title:
An International Randomized Trial of Trans-radial Versus Trans-femoral PCI Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy An Extension to the CURRENT OASIS 7 Substudy EFC5695 Effect of Type of Access for PCI Radial or Femoral on Bleeding Rate-Substudy
Status:
COMPLETED
Status Verified Date:
2011-02
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:
RIVAL
Brief Summary:
This is a multi-national multi-centre randomized study comparing the trans-radial PCI access strategy and the trans-femoral PCI access strategy in ACS patients with UA or NSTEMI or STEMI planned to be treated with an invasive strategy PCI
The hypothesis is that radial access site PCI will be associated with significantly less major bleeding and access site complications compared with a femoral approach without increasing the risk of ischemic events The overall benefit-risk profile will favor a trans-radial approach
The hypothesis is that radial access site PCI will be associated with significantly less major bleeding and access site complications compared with a femoral approach without increasing the risk of ischemic events The overall benefit-risk profile will favor a trans-radial approach
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None