Catheter-directed Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism

NCT04473560 | Unknown

• 1 other identifier: 879/19
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism With Acute Cor Pulmonale

Keywords

pulmonary embolism

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Total mortality rate from pulmonary embolism

  3 months after catheter-directed thrombectomy

• Bleeding events incidence

  3 months after catheter-directed thrombectomy

• Adverse events incidence

  3 months after catheter-directed thrombectomy

Study Arms (2)

Catheter-directed thrombectomy group

Patients with acute pulmonary embolism treated with catheter-directed thrombectomy along with anticoagulation therapy

Device: Catheter-directed thrombectomy

No catheter-directed thrombectomy group

Patients with acute pulmonary embolism treated with anticoagulation therapy alone

Interventions

Catheter-directed thrombectomy DEVICE

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).

Catheter-directed thrombectomy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Greaterpoland, 61-701, Poland

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aleksander Araszkiewicz, Assoc. Prof.

  Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksander Araszkiewicz, Assoc. Prof.

CONTACT

+488549293; aaraszkiewicz@ump.edu.pl

Sylwia Sławek-Szmyt, MD, PhD

CONTACT

+48 8549293; sylwia.slawek@skpp.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 16, 2020
• Study Start: October 1, 2018
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning just after study results publication and ending 24 months following study results publication
• Access Criteria: Investigators who provide a methodologically sound proposal. Proposals should be submitted to aaraszkiewicz@ump.edu.pl

Locations

PL (1)