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

Not Applicable

Completed

• Conditions: Myocardial Infarction
• Interventions: Procedure: guiding catheter; Procedure: diagnostic catheter

• Registration Number: NCT01759043
• Lead Sponsor: Beijing Luhe Hospital

Brief 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

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-24
• Study First Submitted QC: 2012-12-24
• Study First Posted: 2013-01-02
• Primary Completion: 2014-04
• Study Completion: 2015-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Patient must be > 18 years of age.
• Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation≥2mm in two continuous precordial leads or ST elevations≥1mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI.
• Symptoms ≥ 30 min and ≤12 hours
• Patient and treating interventional cardiologist agree for randomization.
• Patient provides written informed consent.
• Diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach.
• Palpable radial or ulnar artery
• Previous experience of the operator with at least 100 cases of radial artery access within the past year

Exclusion Criteria

• Concurrent participation in other investigational study
• Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL.
• Absence of radial or ulnar artery pulsation
• Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
• Uncontrolled hypertension
• Prior CABG surgery
• Fibrinolytic therapy for current MI treatment
• patient have a life expectancy of <180days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
guiding catheter	guiding catheter	a single transradial guiding catheter for coronary angiography and intervention in patients with STEMI
Diagnostic catheter	diagnostic catheter	Diagnostic catheter followed by guiding catheter selection for transradial primary PCI

Primary Outcome Measures

Name	Time	Method
Cath Lab door to balloon time (C2B)	24hours

Secondary Outcome Measures

Name	Time	Method
Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)	30days
door to balloon time	24hours
procedure time	24hours
major adverse cardiac events (MACE)	180days	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
Number of catheters and wires used	24hours
contrast consumption	24hours
fluoroscopy time	24hours

Trial Locations

Locations (1)

Beijing Luhe hospital; 🇨🇳 Beijing, China