Distal Radial Access for Primary PCI in STEMI Patients to Prevent RAO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2023-08-30

Brief Summary

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Randomized-controlled trial to compare early radial artery occlusion via distal vs. conventional transradial access among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention.

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Detailed Description

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Conventional transradial access (TRA) is recommended as the default approach for patients undergoing percutaneous coronary intervention (PCI) according to 2018 ESC guidelines. However, radial artery occlusion (RAO) remains the frequent complication, precluding the future use of the radial artery as an access point for repeat coronary recanalization or as a conduit for coronary artery bypass surgery. More than 50% of patients with ST segment elevation myocardial infarction (STEMI) present multiple vascular lesions, of which 50% require reprocessing non-culprit vessels. Therefore, the patency of the radial artery is crucial for STEMI patients. The distal radial access (DRA), located in the anatomical snuffbox or the dorsum of the hand, was introduced as a promising alternative. Three recent RCTs have shown significant reductions of RAO after DRA compared with TRA. Nevertheless, all of them excluded the patients presenting with STEMI. Therefore, we conduct a prospective, single-center, open-label randomized clinical trial to assess the superiority of preventing RAO at 24 h via DRA when compared TRA among STEMI patients for primary PCI.

Conditions

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ST Segment Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center, open-label, parallel randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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distal radial access

Distal radial access for primary percutaneous coronary intervention in STEMI patients

Group Type EXPERIMENTAL

distal radial access

Intervention Type PROCEDURE

primary percutaneous coronary intervention via distal radial access

conventional transradial access

conventional transradial access for primary percutaneous coronary intervention in STEMI patients

Group Type ACTIVE_COMPARATOR

conventional transradial access

Intervention Type PROCEDURE

primary percutaneous coronary intervention via conventional transradial access

Interventions

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distal radial access

primary percutaneous coronary intervention via distal radial access

Intervention Type PROCEDURE

conventional transradial access

primary percutaneous coronary intervention via conventional transradial access

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* ST-segment elevation myocardial infarction for primary percuteous coronary intervention
* Palpable pulses on both access sites of the radial artery
* Informed consent

Exclusion Criteria

* Thrombolysis before primary percutaneous coronary intervention
* Previous CABG or radio-cephalic fistula using radial artery
* Cardiogenic shock
* Severe arrhythmias
* Severe liver and kidney dysfunction
* Pregnancy
* Enrolment in another study within 1 month
* Inability to obtain written informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No