Comparing the Safety and Efficacy of Cerebral TFA and TRA Methods

NCT ID: NCT06490848

Last Updated: 2024-07-08

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

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-12-01

Brief Summary

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Transradial diagnostic angiography in cardiovascular disease given lower vascular complications. However, neuroendovascular surgeons have not widely adopted the transradial approach for diagnostic approach and interventional procedures. This study aims to compare the efficacy, safety, and patient satisfaction with the transradial approach versus the transfemoral approach in diagnostic cerebral angiography.

Detailed Description

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Transradial diagnostic angiography in cardiovascular disease given lower vascular complications. However, neuroendovascular surgeons have not widely adopted the transradial approach for diagnostic approach and interventional procedures. This study aims to compare the efficacy, safety, and patient satisfaction with the transradial approach versus the transfemoral approach in diagnostic cerebral angiography.

Conditions

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Cerebral Angiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In this study, all consecutive patients referred for diagnostic cerebral angiography at a large academic tertiary care medical center were randomly assigned to two groups: right radial access versus femoral access for diagnostic cerebral angiography.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Transradial approach group

The diagnostic angiography was performed by radial approach.

Group Type ACTIVE_COMPARATOR

Diagnostic cerebral angiography

Intervention Type PROCEDURE

In transradial access, no preprocedural upper extremity collateral blood supply testing was completed. When the radial access is unsuccessful, it is shifted to ulnar or femoral access. All right arms were secured in the fully supine position to allow access to both radial and ulnar arteries. At the conclusion of radial access procedures, a TR band was applied to close the access. Neurological exams as well as radial artery pulse and pulse oximeter of the right first finger were assessed during and on discharge by trained recovery nurses. Femoral access was performed in a standard manner. After the access (femoral or radial), a cerebral angiogram was performed in a standard manner using appropriate catheters (vertebral, bern, Simmons 2 or 3) according to the access. For the radial access, the patient was slightly sedated.

Trasfemoral approach group

The diagnostic angiography was performed by femoral approach.

Group Type ACTIVE_COMPARATOR

Diagnostic cerebral angiography

Intervention Type PROCEDURE

In transradial access, no preprocedural upper extremity collateral blood supply testing was completed. When the radial access is unsuccessful, it is shifted to ulnar or femoral access. All right arms were secured in the fully supine position to allow access to both radial and ulnar arteries. At the conclusion of radial access procedures, a TR band was applied to close the access. Neurological exams as well as radial artery pulse and pulse oximeter of the right first finger were assessed during and on discharge by trained recovery nurses. Femoral access was performed in a standard manner. After the access (femoral or radial), a cerebral angiogram was performed in a standard manner using appropriate catheters (vertebral, bern, Simmons 2 or 3) according to the access. For the radial access, the patient was slightly sedated.

Interventions

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Diagnostic cerebral angiography

In transradial access, no preprocedural upper extremity collateral blood supply testing was completed. When the radial access is unsuccessful, it is shifted to ulnar or femoral access. All right arms were secured in the fully supine position to allow access to both radial and ulnar arteries. At the conclusion of radial access procedures, a TR band was applied to close the access. Neurological exams as well as radial artery pulse and pulse oximeter of the right first finger were assessed during and on discharge by trained recovery nurses. Femoral access was performed in a standard manner. After the access (femoral or radial), a cerebral angiogram was performed in a standard manner using appropriate catheters (vertebral, bern, Simmons 2 or 3) according to the access. For the radial access, the patient was slightly sedated.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All consecutive adult inpatients and outpatients referred for diagnostic cerebral angiography
* the presence of the right radial pulse and at least one femoral pulse

Exclusion Criteria

* age\<18
* pregnant patients
* occlusion of aorta or proximal both iliac/ femoral artery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Humain Baharvahdat

Associate Professor of Endovascular Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mashhad university of medical sciences

Mashhad, Razavi Khorasan Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Humain Baharvahdat, MD

Role: CONTACT

+ 98 915 1100 400

Farid Qoorchi Moheb Seraj, MD

Role: CONTACT

+98 936 939 24 44

Facility Contacts

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Humain Baharvahdat, MD

Role: primary

+98 915 1100 400

Farid Qoorchi Moheb Seraj, MD

Role: backup

98 936 939 24 44

Other Identifiers

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4001116

Identifier Type: -

Identifier Source: org_study_id

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