Symphony Thrombectomy for Pulmonary Embolism
Recruiting in Palo Alto (17 mi)
+18 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Imperative Care, Inc.
Must not be taking: Thrombolytics, Anticoagulants, Chemotherapy
Disqualifiers: Kidney dysfunction, Cardiac arrest, Cancer, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have used thrombolytics (clot-dissolving drugs) within 14 days before the baseline CTA (a type of imaging test).
Is the Symphony Thrombectomy System safe for treating pulmonary embolism?
The safety of percutaneous thrombectomy (a procedure to remove blood clots) for pulmonary embolism was evaluated in a study, showing a 4% rate of major bleeding events and comparable mortality rates to other treatments. This suggests it is generally safe, especially for patients who cannot use other clot-busting drugs.
12345How is the Symphony Thrombectomy System treatment different from other treatments for pulmonary embolism?
The Symphony Thrombectomy System is a mechanical treatment that physically removes blood clots from the lungs, offering an alternative to systemic thrombolysis (using drugs to dissolve clots) which can have bleeding risks. Unlike surgical embolectomy, which is invasive and high-risk, this system provides a less invasive option for patients with pulmonary embolism.
56789Eligibility Criteria
This trial is for adults aged 18-80 with recent pulmonary embolism (PE), confirmed by CTA, who have symptoms of PE and a stable blood pressure and heart rate. Participants must have an enlarged right ventricle but be in a stable condition to give consent and follow the study protocol.Inclusion Criteria
Your heart rate was stable and below 130 beats per minute prior to the procedure.
I am showing signs of a possible pulmonary embolism.
I am between 18 and 80 years old.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism
48 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment
30 days
Participant Groups
The Symphony Thrombectomy System is being tested for safety and effectiveness in removing blood clots from the lungs (pulmonary embolism). This device aims to improve cardiovascular health by treating these potentially life-threatening clots.
1Treatment groups
Experimental Treatment
Group I: Symphony Thrombectomy systemExperimental Treatment1 Intervention
Mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism.
Symphony Thrombectomy System is already approved in United States for the following indications:
🇺🇸 Approved in United States as Symphony Thrombectomy System for:
- Peripheral vascular disease
- Deep vein thrombosis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Heart Hospital Baylor PlanoPlano, TX
Northwell HealthMount Kisco, NY
Tallahassee Memorial HospitalTallahassee, FL
Emory UniversityAtlanta, GA
More Trial Locations
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Who Is Running the Clinical Trial?
Imperative Care, Inc.Lead Sponsor
References
Treatment of infrainguinal arterial thromboembolic acute occlusions with the Aspirex® mechanical thrombectomy device. [2019]Label="OBJECTIVE" NlmCategory="OBJECTIVE">In this study, we investigated the safety and effectiveness of the Aspirex® mechanical thrombectomy system for the treatment of acute infrainguinal arterial thromboembolic occlusions.
Catheter-directed aspiration thrombectomy and low-dose thrombolysis for patients with acute unstable pulmonary embolism: Prospective outcomes from a PE registry. [2020]To evaluate the efficacy and safety of aspiration thrombectomy in combination with low-dose catheter-directed thrombolysis for acute unstable pulmonary embolism (PE).
Percutaneous thrombectomy in patients with intermediate- and high-risk pulmonary embolism and contraindications to thrombolytics: a systematic review and meta-analysis. [2023]Catheter-directed interventions have slowly been gaining ground in the treatment of pulmonary embolism (PE), especially in patients with increased risk of bleeding. The goal of this study is to summarize the evidence for the efficacy and safety of percutaneous thrombectomy (PT) in patients with contraindications to systemic and local thrombolysis. We performed a systematic review and meta-analysis using MEDLINE, Cochrane, Scopus and the Web of Science databases for studies from inception to March 2022. We included patients with intermediate- and high-risk PE with contraindications to thrombolysis; patients who received systematic or local thrombolysis were excluded. Primary endpoint was in-hospital and 30-day mortality, with secondary outcomes based on hemodynamic and radiographic changes. Major bleeding events were assessed as a safety endpoint. Seventeen studies enrolled 455 patients, with a mean age of 58.6 years and encompassing 50.4% females. In-hospital and 30-day mortality rates were 4% (95% CI 3-6%) and 5% (95% CI 3-9%) for all-comers, respectively. We found a post-procedural reduction in systolic and mean pulmonary arterial pressures by 15.4 mmHg (95% CI 7-23.7) and 10.3 mmHg (95% CI 3.1-17.5) respectively. The RV/LV ratio and Miller Index were reduced by 0.42 (95% CI 0.38-46) and 7.8 (95% CI 5.2-10.5). Major bleeding events occurred in 4% (95% CI 3-6%). This is the first meta-analysis to report pooled outcomes on PT in intermediate- and high-risk PE patients without the use of systemic or local thrombolytics. The overall mortality rate is comparable to other contemporary treatments, and is an important modality particularly in those with contraindications for adjunctive thrombolytic therapy. Further studies are needed to understand the interplay of anticoagulation with PT and catheter-directed thrombolysis.
Comparison of interventions for intermediate to high-risk pulmonary embolism: A network meta-analysis. [2023]Multiple interventions, including catheter-directed therapy (CDT), systemic thrombolysis (ST), surgical embolectomy (SE), and therapeutic anticoagulation (AC) have been used to treat intermediate to high-risk pulmonary embolism (PE), but the most effective and safest treatment remains unclear. Our study aimed to investigate the efficacy and safety outcomes of each intervention.
Surgical treatment of acute pulmonary embolism--a 12-year retrospective analysis. [2012]Surgical embolectomy for acute pulmonary embolism (PE) is considered to be a high risk procedure and therefore a last treatment option. We wanted to evaluate the procedures role in modern treatment of acute PE.
Management of pulmonary embolism with rheolytic thrombectomy. [2021]Catheter thrombectomy combining thrombus destruction with local thrombolysis has been used in patients with pulmonary embolism (PE) who are unstable or have significant right heart dysfunction, but have contraindications to systemic thrombolytic therapy.
Outcomes After Surgical Pulmonary Embolectomy for Acute Pulmonary Embolus: A Multi-Institutional Study. [2022]Surgical pulmonary embolectomy (SPE) has been sparingly used for the successful treatment of massive and submassive pulmonary emboli. To date, all data regarding SPE have been limited to single-center experiences. The purpose of this study was to document short-term outcomes after SPE for acute pulmonary emboli (PE) at four high-volume institutions.
Management of acute massive pulmonary embolism: Is surgical embolectomy inferior to thrombolysis? [2022]Although current guidelines for pulmonary embolism (PE) treatment recommend surgical embolectomy when thrombolysis is contraindicated or has failed, their clinical outcomes rarely have been compared directly.
Outcomes of Mechanical Thrombectomy Compared With Systemic Thrombolysis in Pulmonary Embolism: A Comprehensive Evaluation From the National Inpatient Sample Database. [2022]Systemic thrombolysis (ST) may not be ideal for many patients with acute pulmonary embolism (PE) due to bleeding risk. In this analysis, we evaluated the safety and effectiveness of mechanical thrombectomy (MT) as an alternative to ST for acute PE.