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Evaluating the Safety and Effectiveness of the ATC System Device for Treating Acute Pulmonary Embolism in Adults
Led by Akura Medical · Updated on 2025-07-28
30
Participants Needed
4
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the ATC System, a medical device designed to mechanically remove clots and restore blood flow in patients with acute pulmonary embolism PE. This is a prospective, single-arm, interventional, multicenter study focusing on adults aged 18 to 90 years who show clinical signs of acute PE and meet specific medical criteria. Participants will undergo mechanical thrombectomy using the ATC System to treat their acute PE. The study involves a single treatment procedure with monitoring of outcomes shortly after the intervention. The safety and effectiveness of this device will be assessed at 48 hours post-procedure, with additional safety evaluations at 30 days. During the study, participants will be closely observed through clinical assessments and imaging to evaluate the devices performance and monitor for any major adverse events related to the procedure or device. Outcome measures focus on effectiveness at 48 hours and safety at both 48 hours and 30 days post-procedure. The total participation duration may vary based on follow-up assessments and clinical evaluations.
CONDITIONS
Brief Title
Safety and Effectiveness of the ATC System in the Treatment of Acute PE
Research Team
R
Rukhsana Khanum
U
Uday Illindala
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