NCT01735110

PREPARE：Assessing the Safety and Efficacy of Radial Versus Femoral Approach PCI

A Prospective, Multicenter, Randomized Trial Assessing the Safety and Efficacy of PCI Via Radial Versus Femoral Approach in Patients With Left Main and/or Three-Vessel Disease

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of PREPARE trial is to evaluate the long-term safety and efficacy of TRI versus TFI for PCI in patients with left main (LM) and/or three-vessel coronary artery disease.

Detailed description

Transradial intervention (TRI) has been widely practiced in China, accounting for approximate 80 to 90% of procedures. A recent meta-analysis indicated that TRI has advantages in reducing major bleeding and ischemic events compared to transfemoral intervention (TFI) after the percutaneous coronary intervention (PCI). However, no clinical trial has yet shown statistical equivalence in terms of long-term efficacy of TRI compared with TFI for the treatment of complex coronary lesions, which is simply due to limited numbers of subjects enrolled. The purpose of PREPARE trial is to evaluate the long-term safety and efficacy of TRI versus TFI for PCI in patients with left main (LM) and/or three-vessel coronary artery disease.

Conditions

• Transradial-transfemoral Coronary Interventions Comparison

Interventions

Type	Name	Description
PROCEDURE	transfemoral intervention (TFI)
PROCEDURE	Transradial intervention

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-03-01
• Completion: 2018-03-01
• First posted: 2012-11-28
• Last updated: 2013-12-12