Clinical trial NCT04473560: Catheter-directed Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism
Official title: Continuous Aspiration Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Embolism With Acute Cor Pulmonale
Keywords: pulmonary embolism
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients hospitalized due to high risk or intermediate-high risk pulmonary embolism.

Brief 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.

Detailed description: 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.

The primary data recorded include details of each patient's clinical status, co-morbidities with the Charlson Comorbidity Index, the implemented catheter-directed therapy, the results of additional studies (lab tests results, electrocardiogram, imaging studies), and the outcome. The study endpoints comprise technical success, clinically relevant procedure-related complications or bleeding events, classified according to the Valve Academic Research Consortium-2 guidelines criteria.

Collecting the fore mentioned data allows for clinicians to better manage the pulmonary embolism patients with increased mortality risk.

Eligibility criteria: Inclusion Criteria:

1. Clinical symptoms and presentation consistent with pulmonary embolism (PE).
2. PE symptoms duration ≤ 14 days.
3. High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy.
4. 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:

   1. Systolic blood pressure \> 90 mmHg and ≤ 100 mmHg
   2. Heart rate ≥ 110/min,
   3. Arterial blood saturation \<90% during spontaneous breathing (atm)
5. 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:

   1. Systolic blood pressure \> 90 mmHg and ≤ 100 mmHg
   2. Heart rate≥ 110/min,
   3. Arterial blood saturation \<90% during spontaneous breathing (atm)

Exclusion Criteria:

1. Pregnancy.
2. Refusal to sign the informed consent form.
3. Presence of intracardiac thrombus.
4. Diagnosed thrombophilia.
5. Severe thrombocytopenia (platelets count below 20 000 µL).
6. History of severe or chronic pulmonary hypertension.
7. Serum creatinine level higher than 1.8 mg/dl.
8. Known serious and uncontrolled sensitivity to radiographic agents.

Primary outcomes:
measure: Reduction of pulmonary arterial pressures
timeFrame: Immediately after catheter-directed thrombectomy procedure
measure: Reduction of vascular obstruction
timeFrame: Immediately after catheter-directed thrombectomy procedure
measure: Clinical improvement during catheter-directed thrombectomy (CDT) procedure
timeFrame: Immediately after catheter-directed thrombectomy procedure
measure: Ventricular strain reduction
timeFrame: 24 hours after catheter-directed thrombectomy
measure: Early mortality rate from pulmonary embolism
timeFrame: 24 hours after catheter-directed thrombectomy
Secondary outcomes:
measure: Total mortality rate from pulmonary embolism
timeFrame: 3 months after catheter-directed thrombectomy
measure: Bleeding events incidence
timeFrame: 3 months after catheter-directed thrombectomy
measure: Adverse events incidence
timeFrame: 3 months after catheter-directed thrombectomy
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
state: Greaterpoland
Study officials:
affiliation: Poznan University of Medical Sciences
name: Aleksander Araszkiewicz, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: