A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with high-risk pulmonary embolism

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines:

• a) One of the following: i. Cardiac arrest or ii. obstructive shock (systolic BP \<90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status), in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) and b) Signs of right-ventricular dysfunction on transthoracic echocardiogram or CT scan

• Age ≥18 years

Locations
Other Locations
Germany
Universitätsklinikum Freiburg
RECRUITING
Bad Krozingen
Universitätsklinikum Bonn
RECRUITING
Bonn
Universitätsklinikum Halle
RECRUITING
Halle
Asklepios Klinik St. Georg
RECRUITING
Hamburg
SLK-Kliniken Heilbronn
RECRUITING
Heilbronn
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
RECRUITING
Leipzig
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Universitätsklinikum Mannheim
RECRUITING
Mannheim
Schwarzwald-Baar-Klinikum
RECRUITING
Villingen-schwenningen
Rems-Murr-Kliniken
RECRUITING
Winnenden
Helios Kliniken Wuppertal
RECRUITING
Wuppertal
Contact Information
Primary
Karl Fengler, MD, Assoc. Prof.
karl.fengler@medizin.uni-leipzig.de
+49 341 865-1426
Backup
Holger Thiele, MD, Prof. Dr.
holger.thiele@medizin.uni-leipzig.de
Time Frame
Start Date: 2024-12-27
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 315
Treatments
Active_comparator: conventional care
Patients in the conventional care group will receive guideline directed therapy including reperfusion treatment. If no clinically relevant hemodynamic improvement occurs, catheter-interventional treatment may be used as stated in the current ESC-guidelines
Experimental: Early Catheter-Interventional Treatment + conventional care
Patients in this group will undergo a catheter-interventional treatment within 60 min. after randomization. Fibrinolytic treatment will be prepared parallel to interventional treatment preparations to avoid any delay in its administration, if clinically necessary. Catheter-interventional treatment may include any certified devices for the treatment of PE including aspiration thrombectomy, local fibrinolytic therapy, local ultrasound treatment as assistance to local fibrinolysis or any combination of these. Transfemoral venous access routes will be used for any catheter-directed treatment using sheath-sizes as recommended in the IFUs by the respective manufacturers. Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation. The choice of the catheter types and sizes will be left to the treating interventionalists' discretion.
Related Therapeutic Areas
Sponsors
Leads: Leipzig Heart Science gGmbH
Collaborators: Helios Health Institute GmbH, Heart Center Leipzig at University of Leipzig

This content was sourced from clinicaltrials.gov