Catheter-directed Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism (CATH-PE)

Continuous Aspiration Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism With Acute Cor Pulmonale
• Intervention / Treatment: Device: Catheter-directed thrombectomy

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Aleksander Araszkiewicz, Assoc. Prof.; Phone Number: +488549293; Email: aaraszkiewicz@ump.edu.pl
• Study Contact Backup: Name: Sylwia Sławek-Szmyt, MD, PhD; Phone Number: +48 8549293; Email: sylwia.slawek@skpp.edu.pl

Study Locations

• Poland
  • Greaterpoland
    • Poznan, Greaterpoland, Poland, 61-701
      • Recruiting
      • Poznan University of Medical Sciences
      • Contact: Aleksander Araszkiewicz, Assoc. Prof.; Email: aaraszkiewicz@ump.edu.pl
      • Contact: Sylwia Sławek-Szmyt; Email: sylwia.slawek@skpp.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients hospitalized due to high risk or intermediate-high risk pulmonary embolism.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Catheter-directed thrombectomy group; Patients with acute pulmonary embolism treated with catheter-directed thrombectomy along with anticoagulation therapy	Device: Catheter-directed thrombectomy; Using common femoral venous access the pigtail diagnostic catheter will be placed into the main pulmonary artery and an initial pulmonary angiogram will be performed to demonstrate the location and extent of thrombi in pulmonary arteries. Then pulmonary arterial pressures will be measured. Subsequently an Indigo catheter (Penumbra, Alameda, California) will be placed and a direct-aspiration first-pass technique will be performed purposefully to attach a large thrombus to the catheter tip by suction and then pull it out through the sheath. The decision to terminate the intervention will be at operator's discretion after careful evaluation of hemodynamic parameters (restoration of the systolic blood pressure≥100 mmHg, heart rate <100/min), improvement of arterial blood saturation≥ 92%, practicable clot burden reduction and total amount of aspirated blood (no more than 300 ml).
No catheter-directed thrombectomy group; Patients with acute pulmonary embolism treated with anticoagulation therapy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of pulmonary arterial pressures	Incidence of the reduction of systolic and mean pulmonary arterial pressures (mmHg) more than 10% immediately after CDT procedure.	Immediately after catheter-directed thrombectomy procedure
Reduction of vascular obstruction	Incidence of the at least 50% reduction of vascular obstruction in the angiography assessed with Miller Index score	Immediately after catheter-directed thrombectomy procedure
Clinical improvement during catheter-directed thrombectomy (CDT) procedure	Incidence of arterial blood saturation increase >92%	Immediately after catheter-directed thrombectomy procedure
Ventricular strain reduction	Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography 24 hours after the CDT.	24 hours after catheter-directed thrombectomy
Early mortality rate from pulmonary embolism	Number of patients who died from pulmonary embolism (right heart failure) during the first 24 hours after CDT.	24 hours after catheter-directed thrombectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total mortality rate from pulmonary embolism	1. Number of patients who died from pulmonary embolism (right heart failure)	3 months after catheter-directed thrombectomy
Bleeding events incidence	Incidence of major bleedings assessed using The Valve Academic Research Consortium-2 criteria	3 months after catheter-directed thrombectomy
Adverse events incidence	Incidence of pulmonary vascular injury assessed on angiography	3 months after catheter-directed thrombectomy

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Principal Investigator: Aleksander Araszkiewicz, Assoc. Prof., Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: pulmonary embolism
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Pulmonary Heart Disease
• Other Study ID Numbers: 879/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underline the results reported in this study, after deidentification (text, figures, tables and appendices)
• IPD Sharing Time Frame: Beginning just after study results publication and ending 24 months following study results publication
• IPD Sharing Access Criteria: Investigators who provide a methodologically sound proposal. Proposals should be submitted to aaraszkiewicz@ump.edu.pl
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No