NCT01759043

Safety and Feasibility of Using a Single Transradial Guiding Catheter for Primary PCI

Safety and Feasibility of Using a Single Transradial Guiding Catheter for Both Left and Right Coronary Angiography and Intervention in Patients With ST-segment Myocardial Infarction(RAPID)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Beijing Luhe Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Rapid Trial is a randomized-controlled trial proposed to test the hypothesis that using a single guiding catheter for left and right coronary angiography and intervention in patients with ST elevation myocardial infarction (STEMI) can reduce procedure time, fluoroscopy time and Cath Lab door to balloon(C2B) time when compared with traditional approach which first underwent coronary angiography with diagnostic catheter followed by guiding catheter selection for intervention.

Detailed description

1. background: Coronary intervention using transradial approach is common worldwide. It is normally necessary to use one diagnostic catheter and guiding catheter in primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI). It is unknown whether using a single guiding catheter for both nonculprit and culprit vessel angiography and intervention during transradial primary percutaneous coronary intervention (PCI) is feasible. 2. objective:The aim of this study is to investigate the feasibility of using a single guiding catheter for left and right coronary angiography and intervention in patients with ST elevation myocardial infarction (STEMI). 3. This was a single-center, prospective, randomized study,patients with STEMI indicated for transradial primary PCI were randomized into two groups : group I consisted of patients who underwent coronary angiography and primary PCI by using a single guiding catheter.GroupII included patients who first underwent coronary angiography with diagnostic catheter followed by guiding catheter selection for intervention. 4. the primary Endpoints a.Cath Lab door to balloon time (C2B) 5. the Secondary endpoints: 1. Occurrence of major adverse cardiac events (MACE) during 6 months * Cardiac death * Target vessel related myocardial infarction * Ischemia driven Target Vessel Revascularization (TVR) * Ischemia driven Target Lesion Revascularization (TLR) * Definite / probable stent thrombosis by ARC definition 2. Number of catheters and wires used 3. Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding) 4. door to balloon time 5. contrast consumption 6. procedure time 7. fluoroscopy time

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	guiding catheter	using a single transradial guiding catheter for coronary angiography and intervention
PROCEDURE	diagnostic catheter	diagnostic for coronary angiography and guiding catheter selection for intervention

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-04-01
• Completion: 2015-12-01
• First posted: 2013-01-02
• Last updated: 2020-07-15

Locations

1 site across 1 country: China