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

NCT ID: NCT01759043

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-12-31

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

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

guiding catheter

a single transradial guiding catheter for coronary angiography and intervention in patients with STEMI

Group Type: EXPERIMENTAL

guiding catheter

Intervention Type: PROCEDURE

using a single transradial guiding catheter for coronary angiography and intervention

Diagnostic catheter

Diagnostic catheter followed by guiding catheter selection for transradial primary PCI

Group Type: ACTIVE_COMPARATOR

diagnostic catheter

Intervention Type: PROCEDURE

diagnostic for coronary angiography and guiding catheter selection for intervention

Interventions

guiding catheter

using a single transradial guiding catheter for coronary angiography and intervention

Intervention Type: PROCEDURE

diagnostic catheter

diagnostic for coronary angiography and guiding catheter selection for intervention

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Luhe Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jincheng Guo, M.D.

Role: STUDY_DIRECTOR

Beijing Luhe Hospital

Locations

Beijing Luhe hospital

Beijing, , China

Countries

China

References

Guo J, Chen W, Wang G, Liu Z, Hao M, Xu M, Zhu F. Safety and Efficacy of Using a Single Transradial MAC Guiding Catheter for Coronary Angiography and Intervention in Patients with ST Elevation Myocardial Infarction. J Interv Cardiol. 2017 Feb;30(1):33-42. doi: 10.1111/joic.12346. Epub 2016 Oct 25.

Reference Type: RESULT

PMID: 27781297 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/27781297/

Related Info

Other Identifiers

CHRDS

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011-7071-01 CHRDS

Identifier Type: -

Identifier Source: org_study_id