Vertex Pulmonary Embolectomy System for Pulmonary Embolism
(SPIRARE II Trial)
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Neptune Medical
Must not be taking: Thrombolytics, Anticoagulants
Disqualifiers: Pulmonary hypertension, Heart failure, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have used thrombolytics (medications that dissolve blood clots) within 30 days, you cannot participate. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the Vertex Pulmonary Embolectomy System treatment for pulmonary embolism?
Research shows that surgical embolectomy, a procedure to remove blood clots from the lungs, is effective in treating acute massive pulmonary embolism, with improved outcomes in recent years. This suggests that the Vertex Pulmonary Embolectomy System, which is designed for similar purposes, may also be effective.
12345How is the Vertex Pulmonary Embolectomy System treatment different from other treatments for pulmonary embolism?
The Vertex Pulmonary Embolectomy System is unique because it likely involves a specialized device or technique for removing blood clots from the lungs, which may offer a less invasive alternative compared to traditional surgical embolectomy that requires open surgery and cardiopulmonary bypass.
678910Eligibility Criteria
This trial is for adults aged 18 to 79 with symptoms of acute pulmonary embolism, confirmed by a CT scan showing blockage in major lung arteries. Participants must have stable blood pressure and agree to follow-up visits. It's not suitable for those outside the age range or who can't consent.Inclusion Criteria
I am between 18 and 79 years old.
I started having symptoms that could be a lung clot less than 2 weeks ago.
I have a confirmed blood clot in a major lung artery.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants are treated with the Vertex Pulmonary Embolectomy System for acute pulmonary embolism
48 hours
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing the Vertex Pulmonary Embolectomy System's safety and effectiveness in removing clots from lung arteries in patients with signs of a severe blockage that strains the heart.
1Treatment groups
Experimental Treatment
Group I: Vertex Pulmonary Embolectomy SystemExperimental Treatment1 Intervention
Patients presenting with clinical signs and symptoms of acute PE and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System
Vertex Pulmonary Embolectomy System is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Vertex Pulmonary Embolectomy System for:
- Acute Pulmonary Embolism
🇪🇺 Approved in European Union as Vertex Pulmonary Embolectomy System for:
- Acute Pulmonary Embolism
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwell HealthStaten Island, NY
Cardiovascular Institute of the SouthHouma, LA
University of North CarolinaChapel Hill, NC
UPMCHarrisburg, PA
More Trial Locations
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Who Is Running the Clinical Trial?
Neptune MedicalLead Sponsor
References
Pulmonary embolectomy in the treatment of submassive and massive pulmonary embolism. [2019]Significant improvements in outcomes after pulmonary embolectomy have resulted in a broadening of indications. We reviewed our experience with pulmonary embolectomy over the past 12 years with an emphasis on preoperative comorbidities and postoperative morbidity and mortality.
Surgical embolectomy in acute massive pulmonary embolism. [2017]Acute pulmonary embolism is a serious condition and despite diagnostic and therapeutic advances, mortality is still high. Anticoagulation, thrombolytic therapy, catheter embolectomy, and open pulmonary embolectomy are therapeutic options. Surgical embolectomy was considered the management of last resort, but recent studies show the effectiveness of this therapeutic modality. We reviewed our 7-year experience of pulmonary embolectomy in patients with acute massive pulmonary embolism from 1997 to 2004. Eleven patients underwent open embolectomy, 7 (64%) were male, and the mean age was 45.6 years. Pulmonary embolism occurred after major surgery in 5 patients (46%), 2 were diagnosed with malignancy and spinal cord injury, and no risk factors were detected in 4. The diagnosis was made by spiral computed tomography alone in 4 patients, and by angiography in 7. Cardiac arrest occurred in 3 patients preoperatively; 2 of them survived. Open pulmonary embolectomy is the most effective treatment for acute massive pulmonary embolism. Cardiac arrest is the worst prognostic factor. Less aggressive clot evacuation in patients who are diagnosed late appears to be effective in minimizing postoperative hemoptysis.
National Outcomes of Surgical Embolectomy for Acute Pulmonary Embolism. [2020]Guidelines outlining the role of surgical embolectomy for acute pulmonary embolism remain consensus based; however, recent outcomes have improved compared with traditional experiences. This study examined contemporary outcomes of patients treated for acute pulmonary embolism on a nationwide scale.
Surgical embolectomy versus thrombolytic therapy in the management of acute massive pulmonary embolism: Short and long-term prognosis. [2022]Comparison between surgical embolectomy and thrombolytic therapy in patients suffering from acute massive pulmonary embolism (AMPE).
Short- and long-term outcomes for the surgical treatment of acute pulmonary embolism. [2022]Acute pulmonary embolism can be a life-threatening condition with a high mortality. The treatment choice is a matter of debate. The early and late outcomes of patients treated with surgical pulmonary embolectomy for acute pulmonary embolism in a single center were analyzed.
[Surgical treatment of pulmonary embolism]. [2009]Surgical embolectomy is established method of treatment of pulmonary embolism. The aim of the study is to evaluate the experience with this procedure.
Transvenous pulmonary embolectomy for acute massive pulmonary embolism. [2019]Transvenous pulmonary embolectomy employing a vacuum-cupped directionally controlled catheter is a relatively new technique used in the management of major pulmonary embolism. We present the findings in a patient with acute massive pulmonary embolism who underwent transvenous pulmonary embolectomy, with immediate and marked improvement in hemodynamic function and survival. Insertion of a new intracaval filter at the same time provided protection against recurrent thromboembolism.
[Surgical treatment of massive pulmonary embolism--the time of the operation and its effectiveness]. [2011]The records of 6 patients undergoing pulmonary embolectomy for massive pulmonary embolism (MPE) at Kurume University Hospital during 17 years were reviewed to determine the management of surgery. The patients consisted of 2 men and 4 women. The patients' ages ranged from 29 to 68 years (mean age, 49.3 years). The records showed that one patient died of brain death after operation and the others survived. All the patients complained of chest pain, anterior chest discomfort and dyspnea. Sudden syncope was observed in 2 patients. Artificial mechanical ventilation was performed preoperatively on 3 patients. Right ventricular load was demonstrated on electrocardiograms and ultrasonograms. Pulmonary angiograms were attempted on two patients and one of them had cardiac arrest during this examination. MPE was suspected by perfusion defect of 50% to 80% of pulmonary vasculature demonstrated on lung perfusion scintigram in 4 patients. Open pulmonary embolectomy with cardiopulmonary bypass (CPB) was performed on all patients using crystalloid cardioplegia and topical cooling. Intraoperative pulmonary angiograms were performed in 4 patients to prevent residual thromboemboli. Since most thromboemboli originate below the level of the vena cava, acute double ligation of the vena cava just below the renal vein was performed to control recurrent embolism. Oral anticoagulant, warfarin, was administered for 3 months after embolectomy as prophylaxis against postoperative recurrent embolism. It is our opinion that an aggressive attitude toward pulmonary embolectomy on CPB is necessary to save lives of MPE patients. This surgical procedure is very easy and safe.
Video assistance for surgical pulmonary embolectomy. [2018]Surgical pulmonary embolectomy is one of the treatment options for massive pulmonary embolism. At our institute, we have recently adopted a strategy of video assistance for better visualization and clearance of distal pulmonary emboli. Here, we describe our experience.
[The diagnosis and fragmentation therapy of acute massive pulmonary embolism with a rotatable pigtail catheter: experimental studies]. [2016]A dedicated pigtail catheter system which allows angiographic documentation and adjunctive mechanical fragmentation of pulmonary emboli was evaluated in an animal experiment.