Safety and Effectiveness of the ATC System in the Treatment of Acute PE
Recruiting
N/A
Interventional Study
Pulmonary Embolism Acute
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 90
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Akura Medical · Industry
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About This Trial
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patient is ≥ 18 and ≤ 90 years old
2. Clinical signs and symptoms consistent with acute PE for \< 14 days
3. CTA evidence of proximal PE
4. RV/LV ratio \> 0.9
5. Systolic BP ≥90 mmHg without the need for vasopressors
6. Stable heart rate (HR) \< 130 BPM prior to procedure
7. …
Contacts