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

Capital Medical University

Status

Completed

Conditions

Myocardial Infarction

Treatments

Procedure: diagnostic catheter

Procedure: guiding catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT01759043

2011-7071-01 CHRDS

CHRDS (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.
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).
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.
the primary Endpoints

a.Cath Lab door to balloon time (C2B)
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

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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