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Tests treatment safety and results for Pulmonary Embolism Acute
Official title Safety and Effectiveness of the ATC System in the Treatment of Acute PE
ClinicalTrials.gov ID: NCT06152341
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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
You likely can't join if
- Prior PE \< 180 days from index procedure
- Thrombolytic use \< 30 days prior to baseline CTA
- Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) \>70 mmHg by right heart catheterization
- FiO2 requirement \>40% or \>6 LPM to keep oxygen saturation \>90%
- Hematocrit \<28%
- Platelets count \<100,000/µL
See the full eligibility criteria
- 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 treatment 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
- Prior PE \< 180 days from index procedure
- Thrombolytic use \< 30 days prior to baseline CTA
- Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) \>70 mmHg by right heart catheterization
- FiO2 requirement \>40% or \>6 LPM to keep oxygen saturation \>90%
- Hematocrit \<28%
- Platelets count \<100,000/µL
- Serum creatinine \>1.8 mg/dL
- International normalized ratio (INR) \>3
- Major trauma injury severity score (ISS) \>15 prior to screening assessment
- Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment
- Cardiovascular or pulmonary surgery within 7 days of index procedure
- Actively progressing cancer treated by chemotherapeutics
- Known bleeding diathesis or coagulation disorder
- Left bundle branch block
- History of severe or chronic pulmonary arterial hypertension
- History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
- History of decompensated heart failure
- History of underlying lung disease that is oxygen dependent
- History of chest irradiation
- History of heparin-induced thrombocytopenia (HIT)
- Contraindication to systemic or therapeutic doses of anticoagulants
- Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention
- Life expectancy \<90 days, as determined by investigator such as stage 4 cancer, frailty or severe COVID infections
- Female who is pregnant or nursing
- Current participation in another investigational drug or device treatment study.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
- São Paulo, Brazil
- Santiago de los Caballeros, Santiago Province, Dominican Republic
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil; São Paulo, Brazil; Santiago de los Caballeros, Santiago Province, Dominican Republic. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.