NCT01704911

Evaluate the Safety And Efficacy of the Transradial Coronary in Comparison With the Transfemoral Coronary Intervention

Determination of the Transradial Versus Transfemoral Coronary Angioplasty

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,700 (estimated)
• Sponsor: CCRF Consulting Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the DRAGON clinical trial is to evaluate the safety and efficacy of the transradial coronary intervention (TRI) in comparison with the transfemoral coronary intervention (TFI).

Detailed description

Historically, performing PCI requires making an access to the peripheral arteries by an arterial puncture or cutting down. This may lead to the serious bleeding complications especially under the situation of dual antiplatelet therapy and/or potent anti-coagulation therapies. TRI is now widely accepted as the most promising alternative for TFI around the world. It is supposed to reduce the incidence of the serious bleeding complication during and after PCI, as well as the total medical cost. There have been several prospective randomized trials comparing the safety and efficacy between TRI and TFI, but none of them had enough power to show the statistically valid equivalence in the efficacy between TRI and TFI. In this study, investigators randomize approximately 1,700 patients into TRI or TFI. Investigators adopt the rate of major adverse cardiac events (MACCE) at 1 year as the primary efficacy endpoint for the study. Based on these rates at 1 year, the sample size for the non-inferiority analysis for the primary efficacy endpoint is calculated. Through this randomization trial, investigators can achieve the scientific evidence for the improved safety and equal efficacy of TRI compared to TFI. This trial has enough statistical power to draw the final conclusion in the debate between TRI and TFI.

Conditions

• Free Rate of Cardiac or Cerebrovascular Events
• Transradial-transfemoral Coronary Interventions Comparison

Interventions

Type	Name	Description
PROCEDURE	Transradial Coronary Intervention
PROCEDURE	Transfemoral Coronary Intervention
DEVICE	Coronary Stent System	Any kind of coronary stent system

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-12-01
• Completion: 2015-03-01
• First posted: 2012-10-12
• Last updated: 2012-10-26

Locations

1 site across 1 country: China