Thrombectomy in Pulmonary Embolism
ConditionPulmonary Embolism and Thrombosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Plymouth NHS Trust
About this trial
Pulmonary embolism is a blood clot on the lung, which can cause death or significant reduced quality of life. Sucking the clot out with a special tube (catheter) is a relatively new procedure that can be performed but doesn't have the data required to properly support its use in some patients. We know this procedure works in patients who have no other options and would almost certainly die without intervention. We currently don't know how well this procedure is tolerated, how well it works and what its complications are in patients who are moderately to severely unwell. The National Institute of Clinical Excellence (NICE), an advisory body, suggests more data is required to support its use in patients who are sick or very sick. This registry aims to support this growing evidence base to workout if the treatment is effective and the associated risks that come with using it. We are collecting data about this procedure and other treatments patients get offered to better inform clinicians and researchers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical signs and symptoms consistent with acute pulmonary embolism with duration of 14 days or less
Patients who present with computed tomography confirmed pulmonary embolism
Defined as intermediate or high-risk pulmonary embolism (according to European Society of Cardiology guidelines)
Date of computed tomography imaging from within a two-year period
Disqualifiers
Known serious, uncontrolled sensitivity to radiographic agents
Computed tomography not available to evaluate pulmonary embolism
Low-risk pulmonary embolism as defined by European Society of Cardiology guidelines
Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational
Trial population
Patients with PE \<14 days and evidence of right heart strain
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 2 trial groupsGroup A: CAVT thrombectomy
Group B: PE with evidence of right heart strain
Trial outcomes
Primary outcomes
1
LV/RV ratio
1\. To evaluate the effectiveness of PE CAVT as a treatment for intermediate and high-risk PE as measured by change pulmonary arterial pressure and in RV/LV (Right Ventricle to Left Ventricle diameter) ratio at 48 (+ 48 /- 24) hours post procedure.
Time frame
48 (+ 48 /- 24) hours post procedure.2
Morbidity and mortality
Ascertain the mortality and morbidity profile for CAVT within intermediate and high-risk PE, within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).
Time frame
within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov