Use of Various Types of Introducers in Conventional Radial Access (TIRE)
The purpose of this intervention study is to compare different types of radial introducers used in traditional radial access in terms of the incidence of complications.
The main questions it aims to answer are:
- Does a smaller outer diameter of the introducer reduce the risk of complications associated with radial access?
- Does the presence of an outer hydrophilic coating on the introducer reduce the risk of complications associated with radial access?
- Does the use of an introducer with a smaller outer diameter and an outer hydrophilic coating reduce the risk of complications associated with radial access? The researchers will compare the number of complications associated with radial access when using conventional diameter, uncoated radial introducers, conventional diameter introducers with an outer hydrophilic coating, or reduced outer diameter introducers with an outer hydrophilic coating.
During the scheduled revascularization procedure, the participants will undergo radial artery catheterization using one of the types of introducers. Complications from the radiation access will be recorded by doctors within 72 hours after the intervention.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Procédure: catheterization of the radial artery using an classic introducer
- Procédure: catheterization of the radial artery using an introducer with a standard outer diameter and an outer hydrophilic coating
- Procédure: catheterization of the radial artery using an introducer with a reduced outer diameter and an outer hydrophilic coating
Description détaillée
Objective: to compare different types of radial introducers used in conventional radial access by the frequency of complications.
Scientific hypotheses:
- The risk of acute radial artery occlusion depends on the outer diameter of the introducer.
- The risk of acute radial artery occlusion depends on the presence of an outer hydrophilic coating on the introducer.
- The risk of persistent radial artery spasm depends on the presence of an outer hydrophilic coating on the introducer.
- The risk of persistent radial artery spasm depends on the outer diameter of the introducer.
Patients were enrolled by endovascular specialists with experience of at least 250 radial-access procedures per year.
Inclusion criteria: clear pulsation of the right radial artery, indications for percutaneous coronary intervention.
Exclusion criteria: previous unsuccessful radial artery catheterization; concomitant pathology limiting patient survival; disorders of the blood coagulation system (hemophilia, thrombocytopathy, etc.); previous coronary artery bypass grafting; occlusion of the right radial artery.
The required sample size was calculated using the method of M. Bland for a high-precision study. The required significance level (α) was 0.001 and the statistical power was 95%. The expected rate of radial artery occlusion in the Rad, Rad polymer, and Rad slender groups was assumed to be 12%, 8%, and 8%, respectively. Under these conditions, the calculated sample size was 2723 patients. The planned loss during the study was 20%. Thus, the minimum sample size was 3268 patients.
The study had an experimental design and complied with the CONSORT protocol. A simple randomization method using a random-number generator was chosen. The type of randomization was permuted block randomization. The total block size was 3000, and the allocation ratio between the groups was 1:1:0.7.
Puncture of the right radial artery was performed after local anesthesia with a 2% lidocaine solution. The radial artery was punctured at the typical site using the puncture needle included in the introducer set, with only the anterior wall being punctured. The type of introducer was selected by randomization using a random-number method, and depending on this assignment the patient was allocated to one of the groups.
All patients underwent percutaneous coronary angioplasty with coronary artery stenting via the right radial artery. The radial artery catheterization technique did not differ between groups. The type of introducer was selected by randomization using a random-number method, and depending on this assignment the patient was allocated to one of the groups. In the Rad group , introducers without a hydrophilic coating were used; in the Rad polymer group , introducers with a hydrophilic coating were used; and in the Rad slender group , thin-walled introducers with a hydrophilic coating were used. The access site was examined within 3 hours after the intervention and then, in the absence of complaints, again at bandage removal. After bandage removal, patients underwent ultrasound examination to confirm radial artery patency. Complications from the radiation access will be recorded by doctors within 72 hours after the intervention.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Kostroma Oblast
-
Kostroma, Kostroma Oblast, Russie, 156013
- E.I. Korolev Kostroma Regional Clinical Hospital
-
-
Moscow
-
Moscow, Moscow, Russie, 119071
- Central Clinical Hospital of St. Alexy Metropolitan of Moscow of the Moscow Patriarchate of the Russian Orthodox Church
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- clear pulsation of the right radial artery
- indications for percutaneous coronary intervention
Exclusion Criteria:
- previous unsuccessful radial artery catheterization
- concomitant pathology limiting patient survival
- disorders of the blood coagulation system (hemophilia, thrombocytopathy, etc.)
- previous coronary artery bypass grafting
- occlusion of the right radial artery
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Rad classic
Introducer with a standard outer diameter and no external hydrophilic coating
|
The right radial artery was punctured under local anesthesia with a 2% lidocaine solution. The radial artery was punctured at a typical location using a puncture needle included in the catheterization kit, puncturing only the anterior wall. An introducer with a standard outer diameter and no external hydrophilic coating was inserted. 5,000 IU of heparin in saline solution was injected into the catheterized artery. All injected solutions, including radiocontrast agents, had a temperature of 36.5-36.7 °C. Hemostasis was achieved by applying a pressure bandage. The access site was examined 3 hours after the intervention, and then, if there were no complaints, it was examined again when the bandage was removed. After the bandage was removed, patients underwent an ultrasound examination to confirm the patency of the radial artery. Complications were recorded within 3 days after the intervention. |
|
Expérimental: Rad polymer
Introducer with a standard outer diameter and an outer hydrophilic coating
|
Description: The right radial artery was punctured under local anesthesia with a 2% lidocaine solution. The radial artery was punctured at a typical location using a puncture needle included in the catheterization kit, puncturing only the anterior wall. An introducer with a standard outer diameter and an outer hydrophilic coating was using. 5,000 IU of heparin in saline solution was injected into the catheterized artery. All injected solutions, including radiocontrast agents, had a temperature of 36.5-36.7 °C. Hemostasis was achieved by applying a pressure bandage. The access site was examined 3 hours after the intervention, and then, if there were no complaints, it was examined again when the bandage was removed. After the bandage was removed, patients underwent an ultrasound examination to confirm the patency of the radial artery. Complications were recorded within 3 days after the intervention. |
|
Expérimental: Rad slender
Introducer with a reduced outer diameter and an outer hydrophilic coating
|
Description: The right radial artery was punctured under local anesthesia with a 2% lidocaine solution. The radial artery was punctured at a typical location using a puncture needle included in the catheterization kit, puncturing only the anterior wall. An introducer with a reduced outer diameter and an outer hydrophilic coating was using. 5,000 IU of heparin in saline solution was injected into the catheterized artery. All injected solutions, including radiocontrast agents, had a temperature of 36.5-36.7 °C. Hemostasis was achieved by applying a pressure bandage. The access site was examined 3 hours after the intervention, and then, if there were no complaints, it was examined again when the bandage was removed. After the bandage was removed, patients underwent an ultrasound examination to confirm the patency of the radial artery. Complications were recorded within 3 days after the intervention. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Acute radial artery occlusion after catheterization
Délai: Within 72 hours after radial artery catheterization
|
Acute radial artery occlusion was confirmed by ultrasound examination
|
Within 72 hours after radial artery catheterization
|
|
Radial artery perforation
Délai: Perioperative/Periprocedural
|
Angiography-confirmed perforation of the radial artery
|
Perioperative/Periprocedural
|
|
Radial artery false aneurysm
Délai: Within 72 hours after radial artery catheterization
|
A false aneurysm of the radial artery was confirmed by ultrasound examination
|
Within 72 hours after radial artery catheterization
|
|
Hematoma by classification EASY Grade II
Délai: Within 72 hours after radial artery catheterization
|
Hematoma by classification EASY Grade II was confirmed by ultrasound examination
|
Within 72 hours after radial artery catheterization
|
|
Persistent radial artery spasm
Délai: Perioperative/Periprocedural
|
Persistent radial artery spasm confirmed by angiography
|
Perioperative/Periprocedural
|
Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 260/1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .