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To evaluate the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute pulmonary embolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE | Experimental | Prospective single-arm trial reporting the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute pulmonary embolism. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | Device | Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 for the treatment of acute pulmonary embolism |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in RV/LV ratio | Reduction in RV/LV ratio between baseline and 48 hours post-procedure assessed by paired computed tomography pulmonary angiography (CTPA) | 48 hours |
| Incidence of Adverse Events [Safety and Tolerability] | The primary safety endpoint is the incidence of adverse events by type and seriousness through 12 months. The number and proportion of subjects who experienced at least one adverse event will be summarized, and the 95% confidence interval of the proportion will be presented. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in clot burden | • Reduction in clot burden (measured by refined Modified Miller Index score) between baseline and 48 hours post-procedure assessed by paired CTPA | 48 hours |
| Use of thrombolytics |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac MRI | • Cardiac MRI at 12-months post-procedure (for up to 100 patients) to assess:
| 12 months |
Inclusion Criteria:
Symptomatic, CTPA-proven acute PE with a maximum duration of symptoms of 14 days, showing a filling defect in at least one main or proximal lobar pulmonary artery
RV/LV diameter ratio ≥ 1.0 assessed by CTPA
Serum troponin levels above upper limit of normal as per hospital policy
≥ 18 years of age
At least one of the following:
Willing and able to provide written informed consent prior to receiving study specific procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mitch Vanderpoll | Contact | +447790921819 | mvanderpoll@angiodynamics.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Sharp | University College Dublin, Rep. of Ireland | Principal Investigator |
| Erik Klok | Leiden UMC, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Medical Sciences | Recruiting | Poznan | Poland |
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| Label | URL |
|---|---|
| Related Info | View source |
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|
Use of thrombolytics within 48 hours of the index procedure
| 48 hours |
| Change in Biomarkers | Change in troponin, BNP, and D-dimer from baseline to 48 hours post-procedure | 48 hours |
| Composite Major Adverse Events |
| 7 days |
| Individual Major Adverse Events | Individual Major Adverse Events within 7 days of the index procedure
| 7 days |
| Days in ITU | Days in ITU post-index procedure admission | 7 days |
| All-cause mortality | All-cause mortality within 30 days of the index procedure | 30 days |
| PE-related mortality | • PE-related mortality within 30 days of the index procedure | 30 days |
| Device-related Serious Adverse Events | Device-related Serious Adverse Events (SAEs) within 30 days of the index procedure | 30 days |
| Days In-patient | Number of days in-patient on index procedure admission | 30 days |
| Hospital readmission | Hospital readmission rate through 30 days | 30 days |
| Symptom burden exercise test | 6 minute walking test (MWT) at 30 days post-procedure | 30 days |
| Symptom burden classification | New York Heart Association (NYHA) classification at 30 Days post-procedure | 30 Days |
| Functional outcome review | PROMs at 30 Days post-procedure:
| 30 Days |
| Symptomatic PE recurrence | Symptomatic PE recurrence at 30 days post-procedure | 30 days |
| Symptom burden exercise test | 6 minute walking test (MWT) at 6 months post-procedure | 6 months |
| Symptom burden classification | New York Heart Association (NYHA) classification at 6 months post-procedure | 6 months |
| PE-related readmission | - PE-related hospital readmission rate through 12 months post-procedure | 12 months |
| Symptom burden exercise test | 6 minute walking test (MWT) at 12months post-procedure | 12 months |
| Symptom burden classification | New York Heart Association (NYHA) classification at 12 months post-procedure | 12 months |
| Functional outcome review | PROMs at 12 months post-procedure:
| 12 months |
| CTEPH Diagnosis | Diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) at 12 months post-procedure | 12 months |
| Peak Oxygen Consumption |
• Peak Oxygen consumption (for up to 100 patients): PVO2 measured during cardiopulmonary exercise test at 12 months post-procedure |
| 12 months |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017131 | Thrombectomy |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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