The primary study objective is to evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed…
ID
Source
Brief title
Condition
- Pulmonary vascular disorders
- Vascular therapeutic procedures
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the rate of Major Adverse Events (MAE). MAEs are
defined as a composite, when one or more of the following events occur:
• Device-related mortality through 48 hours after the index procedure, or
• Major bleeding through 48 hours after the index procedure, or
• Intra-procedural device or procedure-related adverse events, including:
o Clinical deterioration defined by hemodynamic or respiratory worsening, or o
Device-related pulmonary vascular injury, or
o Device-related cardiac injury
Secondary outcome
Secondary Safety Endpoints:
• Individual components of the MAE composite endpoint
• Major access-site complications requiring open surgical or endovascular
intervention or blood transfusion
• All-cause mortality through 30 days
• Device-related serious adverse events within 30 days
Secondary Effectiveness Endpoints:
• Reduction in pulmonary artery pressures during the procedure;
• Hemodynamic improvements during the procedure, including cardiac index
(CI) and stroke volume index (SVI), right ventricular stroke work index
(RVSWI), pulmonary artery pulsatility index (PAPi) and total pulmonary vascular
resistance (TPVR)
• Reduction in right-ventricular/left-ventricular (RV/LV) ratio from baseline
to 30 days and 6 months; as measured by echocardiography
Utility Measures:
• Fluoroscopy time
• Contrast used
• Thrombectomy time
• Estimated blood loss during the index procedure
• Length of intensive care unit stay, if any
• Length of total hospital stay
Background summary
Pulmonary embolism (PE) occurs when venous bloot clots (thrombi) travel from
the peripheral veins, through the heart, and lodge in the lung (pulmonary)
arterial circulation. The emboli arise from peripheral locations, usually the
large deep veins of the leg and pelvis, but sometimes from the large veins of
the upper extremities. While small PE may remain asymptomatic and go unnoticed,
larger emboli may result in significant pulmonary artery obstruction, right
heart decompensation, and mortality. Some PE are immediately fatal,
particularly large PE that lodge at the branching of the main pulmonary artery;
the so-called *saddle embolus.* On the other hand, PE may occur in a repeated
fashion, often over months or even years, eventually resulting in a syndrome
known as chronic thromboembolic pulmonary hypertension ("CTEPH"). Massive PE is
defined as when a patient presents with shock from acute right ventricular
decompensation. Early, definitive treatment is necessary to prevent the rapid,
downhill spiral that culminates in a patient*s death.
Anticoagulation with the removal of the occluding pulmonary artery thrombus is
indicated, either by medication (pharmacologic), mechanical means, or a
combination of both. In certain cases, open surgical pulmonary embolectomy and
even extracorporeal membrane oxygenation (ECMO) may be necessary. Fortunately,
massive pulmonary embolism occurs in less than 10% of cases.
While treatment of high-risk and low-risk patients ("massive PE" and "small
PE") is clear, there is scant data on which to base therapeutic decisions for
the intermediate-risk group. There has been recent enthusiasm for endovascular
interventional treatment modalities, however, utilizing catheter-directed
thrombolysis, ultrasound-accelerated thrombolysis, or mechanical thrombectomy.
Study objective
The primary study objective is to evaluate the safety and effectiveness of the
FlowTriever System for use in the removal of emboli from the pulmonary arteries
in the treatment of acute pulmonary embolism (PE). The use of the device will
be assessed in a real-world population, with eligibility criteria that closely
approximate its use in clinical practice.
Study design
The FLASH Registry is a prospective, single-arm, multicenter study of the
FlowTriever System for intermediate-risk (submassive) and high-risk (massive)
PE.
Study burden and risks
The study consists solely of collecting specific data for research purposes. As
a result, the risks to subjects participating in the study are no different
than for patients treated with the FlowTriever outside the study context. Study
activities that fall outside standard care will require some extra time from
the patient.
St. Jakobs-Strasse 7
Basel 4052
CH
St. Jakobs-Strasse 7
Basel 4052
CH
Listed location countries
Age
Inclusion criteria
1. Age >= 18 years
2. Clinical signs and symptoms consistent with acute pulmonary embolism (PE)
3. Echo, CTPA, or pulmonary angiographic evidence of proximal filling defect in
at least one main or lobar pulmonary artery
4. Scheduled for PE treatment with the FlowTriever System per the
Investigator*s discretion
Exclusion criteria
1. Unable to anticoagulate with heparin or alternative
2. Diagnosed with a minor PE with less than a 0.9 RV/LV ratio
3. Known sensitivity to radiographic contrast agents that, in the
Investigator*s opinion, cannot be adequately pre-treated
4. Imaging evidence or other evidence that suggests, in the opinion of the
Investigator, the patient is not appropriate for mechanical thrombectomy
intervention (e.g., inability to navigate to target location or predominately
chronic clot)
5. Life expectancy < 30 days, as determined by the Investigator
6. Current participation in another investigational drug or device treatment
study that, in the investigator*s opinion, would interfere with participation
in this study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03761173 |
| CCMO | NL81709.041.22 |