Catheter-directed Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism (NCT04473560) | Clinical Trial Compass
UnknownNot Applicable
Catheter-directed Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism
Poland100 participantsStarted 2018-10-01
Plain-language summary
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development of interventional cardiology has made catheter-directed techniques an important alternative to thrombolytic therapy. The controversy concerns also risk stratification and treatment in intermediate-high risk pulmonary embolism patients. A significant percentage of intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic deterioration and then the prognosis in this group is significantly worse. Catheter-directed techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus increasing cardiac output and immediately restoring hemodynamic stability.
The scope of this study is to evaluate the safety and feasibility of catheter-directed approaches in high-risk and intermediate-high risk pulmonary embolism patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Clinical symptoms and presentation consistent with pulmonary embolism (PE).
. PE symptoms duration ≤ 14 days.
. High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy.
. Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with concomitant at least one of below criterium for minimum 24 hours:
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction of pulmonary arterial pressures
Timeframe: Immediately after catheter-directed thrombectomy procedure
2
Reduction of vascular obstruction
Timeframe: Immediately after catheter-directed thrombectomy procedure
3
Clinical improvement during catheter-directed thrombectomy (CDT) procedure
Timeframe: Immediately after catheter-directed thrombectomy procedure
4
Ventricular strain reduction
Timeframe: 24 hours after catheter-directed thrombectomy
5
Early mortality rate from pulmonary embolism
Timeframe: 24 hours after catheter-directed thrombectomy
. Arterial blood saturation \<90% during spontaneous breathing (atm)
. Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with sudden occurrence of one or more of the below listed factors:
Exclusion criteria
. Pregnancy.
. Refusal to sign the informed consent form.
. Presence of intracardiac thrombus.
. Diagnosed thrombophilia.
. Severe thrombocytopenia (platelets count below 20 000 µL).
. History of severe or chronic pulmonary hypertension.
. Serum creatinine level higher than 1.8 mg/dl.
. Known serious and uncontrolled sensitivity to radiographic agents.