N/A
N=122
Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism
Pulmonary Embolism · Acute Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT05318092 ↗Enrolled (actual)
122
Serious AEs
14.8%
Results posted
Jul 2024
Primary outcome: Primary: Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA) — -0.45 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Angiodynamics, Inc.
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA) |
-0.45 | — |
| PRIMARY Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure. |
5; 117 | — |
| SECONDARY Use of Thrombolytics Within 48 Hours of the Procedure. |
— | — |
| SECONDARY Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure. |
1.4; 5.2 | — |
| SECONDARY Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA). |
-5.6 | — |
| SECONDARY Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure. |
1; 121; 1; 121; 1; 121 | — |
| SECONDARY Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure. |
4; 118; 0; 122 | — |
| SECONDARY Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days. |
1 | — |
Summary
To evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE).
Eligibility Criteria
Inclusion Criteria
- Signed and dated informed consent form.
- 18 years of age and older.
- Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.
- Diagnosis of pulmonary embolism detected from computed tomography angiography (CTA).
- Right Ventricle to Left Ventricle (RV/LV) ratio of 0.9 or higher.
- Systolic blood pressure (SBP) of 90 mmHg or higher
- Heart rate of 130 beats per minute (BPM) or less prior to the procedure.
- Deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.
Exclusion Criteria
Excluded from the study if he/she meets any of the following exclusion criteria
- May be pregnant as determined by a positive pregnancy test or who are breastfeeding.
- Has any contraindication to systemic or therapeutic doses of heparin or anticoagulants.
- Has used thrombolytics (tPA) in the past 30 days of baseline CTA.
- Has pulmonary hypertension with peak pulmonary artery pressure (PAP) > 70 mmHg.
- Fraction of inspired oxygen (FiO2) requirement >40% or >6 liters per minute (LPM) to keep oxygen saturations >90%
- Hematocrit 1.8 mg/dL.
- International Normalized Ratio (INR) > 3
- Has undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) > 15.
- Presence of cancer requiring active chemotherapy.
- Known bleeding diathesis or coagulation disorder.
- Has had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.
- History of severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, underlying lung disease that is oxygen dependent, Heparin-induced thrombocytopenia (HIT) and/or chronic left heart disease with left ventricular ejection fraction ≤ 30%.
- Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.
- Requires Vasopressor after fluids to keep pressure ≥ 90 mmHg.
- With left bundle branch block.
- Has intracardiac lead in the right ventricle or atrium.
- Evidence such as imaging or other that suggests the subject is not appropriate for this procedure.
- Has life expectancy < 90 days.
- Dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).
- Participation in another investigational study
Data sourced from ClinicalTrials.gov (NCT05318092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.