Une étude réelle du système endovasculaire ekosonique dans les populations chinoises avec une embolie pulmonaire aiguë (ANTEATER)
Système endovasculaire ekosonic en Chine RWS (antiater)
This study to collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a multi-center, single arm, prospective, observational, real-world study.To collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care.
Up to 30 patients will be enrolled in this study and up to 30 patients will be enrolled in this study to observation safety and efficacy.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Guangqi Chang, Doctor
- Numéro de téléphone: 020-87755766
- E-mail: changgq@mail.sysu.edu.cn
Sauvegarde des contacts de l'étude
- Nom: Cheng Hong, Doctor
- Numéro de téléphone: 020-81568636
- E-mail: gyfyyhc@126.com
Lieux d'étude
-
-
Guangdong
-
Guangzhou, Guangdong, Chine, 510000
- Recrutement
- The first Affiliated Hospital, Sun Yat-sen University
-
Contact:
- Cheng Hong, Doctor
- Numéro de téléphone: 020-81568636
- E-mail: gyfyyhc@126.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
This study will enroll patients who received EkoSonicTM Endovascular System treatment with r-tPA for acute pulmonary thromboembolism, and who could provide sufficient echocardiographic quality to assess the collection of primary endpoint, and prospectively collect the clinical data related to the protocol in the actual clinical diagnosis and treatment
La description
Inclusion Criteria:
- The patients with acute symptomatic pulmonary embolism (Symptomatic duration < 14 days).
- The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image
- Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.
Exclusion Criteria:
- The patients with acute symptomatic pulmonary embolism (Symptomatic duration < 14 days).
- The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image
- Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Single group observational study
To collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care. |
EkoSonicTM Endovascular System and its upgraded versions if applicable The EkoSonicTM Endovascular System is a non-implanted system comprising a sterile, single-use EkoSonic Endovascular Device (Infusion Catheter and Ultrasonic Core) and reusable EKOSTM Control System 4.0(Control Unit, Connector Interface Cable and power cord). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
RV vs LV end-diastolic diameter ratio
Délai: after the completion of EKOS treatment 48 hours compared with the baseline
|
The change in the right ventricular end-diastolic diameter to left ventricle end-diastolic diameter ratio at 48hours after the completion of EKOS treatment compared with the baseline. |
after the completion of EKOS treatment 48 hours compared with the baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
RV vs LV end-diastolic diameter ratio
Délai: after the completion of EKOS treatment 24 hours, Discharge(Approximately within 15 days after completed treatment) , after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline，through study completion, an average of 1 year
|
The change in the right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio at 24h, Discharge(Approximately within 15 days after completed treatment) , after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline. |
after the completion of EKOS treatment 24 hours, Discharge(Approximately within 15 days after completed treatment) , after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline，through study completion, an average of 1 year
|
|
PE events after the completion of EKOS treatment
Délai: After the completion of EKOS treatment 24hours, 48hours,Discharge(Approximately within 15 days after completed treatment), after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline
|
Recurrent symptomatic PE events after the completion of EKOS treatment. |
After the completion of EKOS treatment 24hours, 48hours,Discharge(Approximately within 15 days after completed treatment), after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline
|
|
Serious adverse events related to EKOS or procedure
Délai: After enrollment to end of study，through study completion, an average of 1 year
|
All of SAE related to EKOS or procedure |
After enrollment to end of study，through study completion, an average of 1 year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Guangqi Chang, Doctor, First Affiliated Hospital, Sun Yat-Sen University
- Chercheur principal: Cheng Hong, Doctor, The First Affiliated Hospital of Guangzhou Medical University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Autres numéros d'identification d'étude
- S6364
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
produit fabriqué et exporté des États-Unis.
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 .