Safety and Effectiveness of the ATC System in the Treatment of Acute Pulmonary Embolism
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the ATC System in subjects with acute pulmonary embolism (PE).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• Patient is ≥ 18 and ≤ 90 years old
• Clinical signs and symptoms consistent with acute PE for \< 14 days
• CTA evidence of proximal PE
• RV/LV ratio \> 0.9
• Systolic BP ≥90 mmHg without the need for vasopressors
• Stable heart rate (HR) \< 130 BPM prior to procedure
• Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
• Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures
Locations
Other Locations
Brazil
Instituto Dante Pazzanese de Cardiologia
RECRUITING
São Paulo
Instituto do Coracao
RECRUITING
São Paulo
Dominican Republic
Centro de Intervenciones Cardiovasculares
RECRUITING
Santiago De Los Caballeros
Corazones Del Cibao
NOT_YET_RECRUITING
Santiago De Los Caballeros
Contact Information
Primary
Rukhsana Khanum
clinicalaffairs@akuramed.com
+1 408-560-2500
Backup
Uday Illindala
clinicalaffairs@akuramed.com
+1 408-560-2500
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2025-09-15
Participants
Target number of participants: 30
Treatments
Experimental: Patients with Acute Pulmonary Embolism
Patients undergoing mechanical thrombectomy for acute pulmonary embolism.
Related Therapeutic Areas
Sponsors
Leads: Akura Medical