DIStal Versus COnventional RADIAL Access for Coronary Angiography and Intervention

DISCO Radial Trial: DIStal Versus COnventional RADIAL Access for Coronary Angiography and Intervention: a Randomized Multicenter Trial

Patrocinadores

Patrocinador principal: Terumo Europe N.V.

Colaborador: Cromsource

Fuente Terumo Europe N.V.
Resumen breve

The objective of this study is to demonstrate the superiority of Distal Radial Access (DTRA) to Conventional Transradial Access (CTRA) regarding forearm radial artery occlusion (RAO).

This trial plans to include 1300 patients in around 12 locations around the world (11 participating sites in Europe and 1 participating site in Japan).

Descripción detallada

DISCO RADIAL is a prospective, global, open label, multi-centre randomized controlled trial with plan to include approximately 1300 patients on who transradial coronary angiography and/or intervention is performed. The patients will be randomized in 1:1 ratio to either Distal Transradial Artery Access (DTRA) or Conventional Transradial Access (CTRA) arm. In both arms 6Fr Glidesheath Slender (GSS) will be used as access sheath.

The sponsor will work in accordance with standard operating procedures (SOP) and the Monitoring Plan in order to ensure adherence to the CIP and applicable regulations at the investigational sites.

The Monitoring Plan is built according to a risk-based monitoring approach and describes the level of source data verification to be performed by the monitors.

Risk-based monitoring approach uses all available means to supervise the trial (central monitoring, remote monitoring and on-site monitoring), focusing in critical data points and issues ensuring that adequate monitoring (central, remote and on-site) at each site is completed to ensure protection of the rights and safety of the subjects and the quality and integrity of the data collected and submitted.

The sponsor shall provide training and the necessary guidelines to assist each investigational site on the data collection in the eCRF. Each site is responsible to report the available data requested by the CIP. In order to ensure data quality and avoid missing information in the eCRF, edit checks are designed during database development. In addition, Sponsor's CRA and Data Management team will be responsible to review the data and raise queries accordingly into the eCRF. An audit trail logging all data entered and edited is available within the EDC system. All source documents are maintained in the hospital files ready for inspection by the Sponsor and regulatory authorities upon request. The Sponsor will inform the investigator of the time period for retaining these records as per applicable regulatory requirements.

The following analysis sets will be considered for the statistical analysis :

As Treated Population This population includes all patients who were treated and undergo the studied procedure. Patients will be assigned to the study treatement groups according to the actual received treatement.

Intention-To-Treat Population This population includes all patients who have been randomized to a treatement. Patients will be assigned to the study treatement groups according to the treatement to which they have been randomized.

Per-Protocol Population This population includes all patients who were treated and undergo the studied procedure, excluding all patients with major violations to the protocol (e.g. wrong inclusion, missing data, mis-randomization, crossover, drop off before discharge). Patients will be assigned to the study treatement groups according to the treatement to which they have been randomized. All the protocol deviations will be reported in statistical report.

Assuming a rate of forearm RAO of 1% in DTRA and 3.5% in CTRA based on on two-sided alpha = 0.050 and power = 80%, 1:1 randomization needs 551 patients for each group to detect statistically significant differences in forearm RAO proportions. Then, given the crossover rate of 10% and the drop out rate of 5% for both group, at least 648 patients needs for each group to maintain proper statistical power. In total 1300 subjects will be randomized.

The primary endpoint analysis will be performed on ITT (Intention-To-Treat) population, by using two-sided superiority test with alpha = 0.05. Due to the short observation period (3 days ±2), a low number of missing data is expected. However, in case it exceeds 15-20%, missing, unused or spurious data will be considered using a tipping point analysis for each population. The comparaison in RAO rates between treatment groups will be tested by Chi-squared tests or Fisher's exact test, as appropriate. Odd-Ratio with IC95% will be calculated. Logistic regression analyses will be used to test the tendency.

Estado general Not yet recruiting
Fecha de inicio November 25, 2019
Fecha de Terminación November 28, 2020
Fecha de finalización primaria November 28, 2020
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Forearm radial artery occlusion (RAO) rate before discharge up to 5 days
Resultado secundario
Medida Periodo de tiempo
Rate of successful sheath insertion up to 2 days
Rate of access site crossover up to 2 days
Total procedural time up to 2 days
Sheath insertion time up to 2 days
Puncture site bleeding according to EASY criteria up to 5 days
Overall bleeding according to BARC criteria up to 5 days
Vascular access-site complication up to 5 days
Rate of radial artery spasm up to 2 days
Rate of distal radial artery occlusion (dRAO) up to 5 days
Patent hemostasis was achieved or not (CTRA) by reverse barbeau test up to 5 days
Time required to reach hemostasis up to 5 days
Pain associated with the procedure: Visual Assessment Scale (VAS) up to 5 days
Inscripción 1300
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Coronary angiography and or Percutaneous coronary Intervention

Descripción: Radial access punture site

Elegibilidad

Criterios:

Inclusion Criteria:

- Patient is at least 18 years of age.

- Patient has provided written informed consent.

- Patient is undergoing diagnostic coronary angiography and/or PCI.

- Patient is willing to comply with all protocol-required evaluations during the hospitalization.

- Patient is suitable for both DTRA and CTRA using 6Fr GSS.

Exclusion Criteria:

- Patient has a medical condition that may cause non-compliance with the protocol and/or confound the data interpretation.

- Patients on chronic hemodialysis.

- Patients presenting with ST-elevated myocardial infarction (STEMI).

- Patients have chronic total occlusion (CTO) lesions in coronary artery.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Adel Aminian, Dr. Principal Investigator Hôpital Civil Marie Curie
Contacto general

Apellido: Irene Barriocanal

Teléfono: +3216381517

Email: [email protected]

Ubicación
Instalaciones: Contacto: Investigador:
Cliniques Universitaires Saint-Luc | Brussels, Belgium Joëlle Kefer, Prof. Joëlle Kefer, Prof. Principal Investigator
Hôpital Civil Marie Curie | Charleroi, Belgium Adel Aminian, Dr. Adel Aminial, Dr. Principal Investigator
Klinikum Minden | Minden, Germany Marcus Wiemer, Prof. Marcus Wiemer, Prof. Principal Investigator
Bács-Kiskun Megyei Kórház | Kalocsa, Hungary Ruzsa Zoltán, Dr. Ruzsa Zoltán, Dr. Principal Investigator
Interventional Cardiologist at Istituto Clinico Humanitas | Milano, Italy Gabriele Gasparini, Dr. Gabriele Gasparini, Dr. Principal Investigator
Sant'Eugenio Hospital | Roma, Italy Gregory Angelo Sgueglia, Dr. Gregory Angelo Sgueglia, Dr. Principal Investigator
Shonan Kamakura General Hospital | Kanagawa, Japan Shigeru Saito, Dr. Shigeru Saito, Dr. Principal Investigator
University Clinic of Cardiology, Skopje | Skopje, North Macedonia Sasko Kedev, Prof. Sasko Kedev, Prof. Principal Investigator
HUG Geneva | Geneva, Switzerland Juan Iglesias, Dr. Juan Iglesias, Dr. Principal Investigator
Royal Stoke University Hospital | Stoke-on-Trent, United Kingdom Karim Ratib, Dr. Karim Ratib, Dr. Principal Investigator
Sunderland Royal Hospital | Sunderland, United Kingdom Nick Jenkins, Dr. Nick Jenkins, Dr. Principal Investigator
Ubicacion Paises

Belgium

Germany

Hungary

Italy

Japan

North Macedonia

Switzerland

United Kingdom

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Distal Transradial Access

Tipo: Other

Descripción: Distal Transradial Access

Etiqueta: Conventional Transradial Access

Tipo: Other

Descripción: Conventional Transradial Access

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: Randomization to distal transradial access or conventional transradial access. Both techniques are standard of care.

Propósito primario: Supportive Care

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov