Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT03886194
Eligibility Criteria:
Inclusion Criteria:
* Han population with age greater than or equal to 14 years old and less than or equal to 85 years;
* Signed informed consent;
* confirmed initial acute pulmonary embolism, within 2 weeks of disease, pulmonary embolism confirmed methods include: CTA/DSA/pulmonary ventilation Imaging: confirmed as at least 1 trunk pulmonary artery or proximal low lobe artery filling defect;
* risk stratification for intermediate high-risk or high-risk pulmonary embolism: 2014ESC stratified definition of high-risk and high-risk: high-risk PE: hemodynamics Obstruction, systolic blood pressure \<90mmHg, greater than 15 minutes; medium and high risk PE: right ventricular dysfunction imaging findings (RV / LV ≥ 0.9) and myocardial damage indicators positive (TNT \> 0.1 ng / ml);
* blood flow at admission The kinetics are stable.
Exclusion Criteria:
* patients with mental illness can not cooperate with the completion of the study; -CTPA / DSA contraindications patients;
* any contraindications listed in the instructions for treatment of the drug involved in the study;
* diseases associated with coagulopathy leading to the risk of clinically relevant bleeding;
* There are active bleeding or high risk of bleeding in patients with anticoagulant thrombolysis contraindications;
* creatinine clearance rate \<30 mL / min;
* life expectancy ≤ 6 months;
* childbearing age or pregnancy, lactation period without appropriate contraceptive measures Subjects;
* participated in any other drug or medical device study within 30 days prior to randomization;
* cases that the investigator considered unsuitable for participation in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
85 Years
Study:
NCT03886194
Study Brief:
Protocol Section:
NCT03886194