TwiFlow Thrombectomy Catheter sYstem for Acute Pulmonary Embolism (Twi-TYPE Study)

Launched by MORNINGSIDE (NANTONG) MEDICAL CO.,LTD · Mar 18, 2023

Keywords

ClinConnect Summary

The Twi-TYPE Study is a clinical trial designed to test a new medical device called the TwiFlow Thrombectomy Catheter System. This device is being studied to see how effective and safe it is for treating patients with acute pulmonary embolism, a serious condition where blood clots block blood flow in the lungs. The trial will take place in multiple hospitals across China and aims to help patients who are diagnosed with this condition and need treatment to clear the blood clots.

To participate in this study, candidates should be between 18 and 75 years old and have symptoms of pulmonary embolism for no longer than 14 days. They must have a specific heart condition related to the embolism and be stable enough to participate, meaning their blood pressure and other health factors meet certain criteria. Participants will need to provide their consent to join the study. It's important to note that there are several health conditions that could prevent someone from being eligible, including certain heart and kidney issues, as well as bleeding disorders. If you or a loved one is considering this trial, you can expect to receive specialized care and monitoring while being part of an effort to improve treatment options for this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18≤ age ≤75, no gender limitation;
• • 2. patients clinically diagnosed as acute pulmonary embolism requiring pulmonary artery thrombosis clearance;
• • 3. RV/LV ratio ≥0.9;
• • 4. Duration of pulmonary embolism symptoms ≤14 days
• • 5. Systolic blood pressure ≥90mmHg
• • 6. Patients who agreed to participate in the study and voluntarily signed the informed consent.
• Exclusion Criteria:
• • 1. Target vessel diameter \< 6.6mm;
• • 2. Calcification, plaque or stenosis of target lesions;
• • 3. Pulmonary arterial hypertension with peak pulmonary arterial pressure \>70mmHg;
• • 4. Vasopressor is required after infusion to maintain pressure ≥90mmHg;
• • 5. Hematocrit \< 28%;
• • 6. Patients with left bundle branch block;
• • 7. A history of chronic left heart failure and left ventricular ejection fraction≤30%;
• • 8. Patients with abnormal renal function (serum creatinine \> 1.8 mg/dL or \>159umol/L);
• • 9. Patients with known coagulopathy or bleeding tendency (platelet\<100×109/L, or INR\> 3);
• • 10. Patients who cannot receive antiplatelet or anticoagulant therapy;
• • 11. Patients who underwent cardiovascular or pulmonary open surgery within 7 days before surgery;
• • 12. Patients with intracardiac thrombosis;
• • 13. Patients treated with extracorporeal membrane oxygenation;
• • 14. Patients known to be allergic to contrast agents;
• • 15. Patients with diseases that may cause difficulty in treatment and evaluation (such as malignant tumor, acute infectious disease, sepsis, general condition that cannot tolerate surgery, life expectancy less than 3 months, etc.);
• • 16. Pregnant and lactating women;
• • 17. Patients who are participating in clinical trials of other drugs or medical devices;
• • 18. Other patients deemed unsuitable for the study by the investigator;