CompletadoNCT07928960Registro de ClinicalTrials.gov

Conventional or Ultrasound Guided Puncture Technique for the Distal Radial Artery, Direct Comparison Study (Sound Distal Trial).

Percutaneous Coronary Intervention

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: No aplica
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 600 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

Over the last few years, a new approach using distal radial access had been employed for a various types of percutaneous interventions. The purpose was to further decrease the rate of vascular complications and proximal radial occlusion (RAO).

The feasibility of distal radial access in several specific groups of patients for conventional, complex coronary and non-coronary procedures was extensively studied and showed a variable rate of success between different operators, using different techniques. The main limitation is the rate of failure in cannulation that is related to the smaller diameter of the distal radial artery and the anatomic variability at the level of access site puncture. One of the solutions advocated by Hadjivassiliou et al. is the use of ultrasound-guided distal transradial acces (dTR)A, which is expected to reduce failure and complication rates.

A recent monocentric, single operator pilot study indicated a lower failure rate with ultrasound than conventional dTRA, without significant differences in puncture time and complication rate between the two approaches.

A specific ultrasound algorithm for distal radial puncture was recently developed and is currently used in our clinical daily practice, showing a 100% rate of success, in a selected group of patients that had favorable anatomic features. Imaging the distal radial artery by ultrasound could potentially be safer, select the proper candidates for this technique and increase the rate of successful cannulation. However, to date, the comparison of feasibility and safety between ultrasound-guided and conventional dTRA has not been reported.

The SOUND Distal trial is a pilot study measuring the reproducibility, rate of success, rate of complications and quality puncture measures.

The primary outcome is comparing the rate of success of dTRA cannulation between conventional and echo guided puncture. Secondary outcomes include quality puncture measures differences between the two approaches regarding patient scale pain/puncture time and number of attempts.

Other secondary end points include technic reproducibility among operators and the total rate of complications for both approaches.

¿Quién podría participar?

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Inclusion Criteria:

Patient older than 18 years requiring diagnostic angiography or PCI.
The subject has stable or acute coronary syndrome, or a positive functional study documenting ischemia.
The subject is eligible for PCI.
The subject is male, or a non-pregnant female.
The subject gives consent prior to study inclusion.

Exclusion Criteria:

Pregnant and/or breast-feeding females.
Patients who intend to have a major surgical intervention within 6 months of enrolment in the study at the level of the vascular site access.
Patients who previously participated in this study.
The subject has suffered a stroke or transient ischemic neurological attack or cerebrovascular accident within the past six months, or has any known intracranial mass, arteriovenous malformation, aneurysm or other intracranial pathology.

Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación: Asignación al azar
Enmascaramiento: Sin enmascaramiento

conventional puncture

conventional puncture for TRA cannulation

Procedure: conventional puncture

echo guided puncture

echo guided puncture for TRA cannulation

Procedure: echo guided puncture

echo guided puncture PROCEDURE

echo guided puncture for PCI

conventional puncture PROCEDURE

conventional puncture for PCI

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