Pulmonary Embolism Acute
Conditions
Keywords
Pulmonary Embolism, Clot, DVT
Brief summary
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vibrato™ Aspiration System for aspiration mechanical thrombectomy in the treatment of acute PE. This is the First in Man clinical study.
Detailed description
The study objective is to evaluate the safety and effectiveness of the Vibrato™ Aspiration System Aspiration System (hereafter referred to as Vibrato™ Aspiration System) for aspiration mechanical thrombectomy in the treatment of acute PE. The Vibrato™ Aspiration System is a vibration-assisted aspiration thrombectomy device including attributes designed to improve trackability, maintain a low-profile configuration, and operate without capital equipment. In addition, the Vibrato™ Aspiration System features a novel vibrating distal tip designed to enhance thrombus removal during aspiration while minimizing vascular injury. The vibrating mechanism may reduce procedure times, improve clot removal efficiency, and decrease the need for adjunctive interventions.
Interventions
DEVICEMechanical Thrombectomy
Mechanical Thrombectomy for the treatment of Acute Pulmonary Embolism
Sponsors
Vicora, Inc.
KCRI
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all following general inclusion criteria: 1. Age ≥ 18 and ≤ 75 years. 2. Clinical signs, symptoms, and presentation consistent with acute PE; 3. PE symptom duration ≤ 14 days; 4. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery) 5. RV/LV ratio of ≥ 0.9 on CTA as assessed by investigator (site determined). 6. Systolic blood pressure ≥ 90 mmHg; 7. Stable heart rate \< 130 BPM prior to procedure; 8. Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment 9. Informed Consent Form signed 10. Subject is willing and able to comply with all Clinical Investigation Plan required follow-up visit
Exclusion criteria
Subjects must not meet any of the following general
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint: Major Adverse Events | 48 hours | Major Adverse Events, a composite of: * Device-related death within 48 hours * Major bleeding within 48 hours * Device-related AEs within 48 hours, including: * Clinical deterioration * Pulmonary vascular injury * Cardiac injury |
| Efficacy Endpoint: Reduction in RV/LV Ratio | 48 hours | Reduction in RV/LV ratio from baseline to 48 hours or discharge by CT angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Endpoint: Length of ICU Stay, Associated with Index Procedure | 30 Days | Length of stay in the ICU associated with the index procedure \[measured in days\] |
| Efficacy Endpoint: Length of Total Hospital Stay | 30 Days | Length of total hospital stay \[measured in days\] |
| Efficacy Endpoint: Post-Index Procedure Hospital Length of Stay | 30 Days | Post-index-procedure hospital length of stay \[measured in days\] |
| Efficacy Endpoint: Procedural Reduction in Pulmonary Artery Mean Pressure | Procedure | Procedural reduction in pulmonary artery mean pressure \[measured in mmHg\] |
| Efficacy Endpoint: Procedural Reduction in Pulmonary Artery Systolic Pressure | Procedure | Procedural reduction in pulmonary artery systolic pressure \[measured in mmHg\] |
| Efficacy Endpoint: Reduction in Total Pulmonary Vascular Resistance | Procedure | Procedural reduction in total pulmonary vascular resistance \[measured in mmHg ⋅ min/L\] |
| Efficacy Endpoint: Change from Baseline in Dyspnea Severity by mMRC Score | 48 Hours | Change from baseline in Dyspnea severity by mMRC score at the 48-hour visit |
| Efficacy Endpoint: Modified Miller Index Score | 48 Hours | Change in modified Miller Index Score (MMIS) between baseline and 48 hours post-procedure as assessed by CTA |
| Safety Endpoint: Device-Related Death | 48 hours | Device-related death within 48 hours |
| Safety Endpoint: Major Bleeding | 48 Hours | Major bleeding within 48 hours |
| Safety Endpoint: Device-Related Clinical Deterioration | 48 Hours | Device-related clinical deterioration within 48 hours |
| Safety Endpoint: Device-Related Pulmonary Vascular Injury | 48 Hours | Device-related pulmonary vascular injury within 48 hours |
| Safety Endpoint: Cardiac Injury | 48 Hours | Cardiac injury within 48 hours |
| Safety Endpoint: Any-Cause Mortality | 30 Days | Any-cause mortality within 30 days |
| Safety Endpoint: Device-Related Serious Adverse Event | 30 Days | Device-related Serious Adverse Events (SAEs) within 30 days |
| Efficacy Endpoint: Change in Mean Pulmonary Artery Pressure | Procedure | Change in mean pulmonary artery pressure measured invasively in the central pulmonary arteries before vs. after the endovascular procedure \[measured in mmHg\] |
| Safety Endpoint: Symptomatic Recurrence of Pulmonary Embolism | 30 Days | Symptomatic recurrence of Pulmonary Embolism (PE) within 30 days |
| Efficacy Endpoint: Procedural Change in Cardiac Index | Procedure | Procedural change in cardiac index \[measured in L/min/m\^2\] |
Countries
Poland
Contacts
CONTACTShawn M Patterson
CONTACTErin M Garcia
Outcome results
None listed