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The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with acute pulmonary embolism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indigo Aspiration System | Device | Indigo Aspiration System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Composite of major adverse events | A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury | 48 hours |
| Performance: Change in RV/LV Ratio | Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available) | 48 hours post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life assessed via PEmb-QoL | Self-assessment of PE related complaints and daily living limitations (including work and social) | 90 days post-procedure |
| Quality of Life assessed via EQ-5D-5L |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute pulmonary embolism
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joanne Krasnoff | Contact | 650-455-4462 | jkrasnoff@penumbrainc.com | |
| Aisha Pascua | Contact | 415-601-9561 | apascua@penumbrainc.com |
| Name | Affiliation | Role |
|---|---|---|
| John Moriarty, MD | University of California, Los Angeles | Principal Investigator |
| Aleksander Araszkiewicz, MD, PhD | Uniwersytecki Szpital Kliniczny w Poznaniu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach Medical Center | Recruiting | Long Beach | California | 90806 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40878986 | Derived | Moriarty JM, Schiro BJ, Dohad SY, Tamaddon H, Davis HC, Shavelle DM, Chrysant GS, Iliadis EA, Dexter DJ 2nd, Ciampi Dopazo JJ, Holden A, West FM, Keeling B, Sharp ASP, Weinberg I. Periprocedural Results and Right Ventricular Outcomes of Computer Assisted Vacuum Thrombectomy Treatment of Acute Pulmonary Embolism: Interim Analysis of 300 Patients From the STRIKE-PE Study. J Am Heart Assoc. 2025 Sep 2;14(17):e039975. doi: 10.1161/JAHA.124.039975. Epub 2025 Aug 29. |
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Self-assessment of activities of daily living
| 90 days post-procedure |
| Functional outcome assessed NYHA | Physician assessment of heart failure symptoms and activity level | 90 days post-procedure |
| Functional outcome assessed via 6MWT | Walking distance over a 6 minute period to assess functional capacity | 90 days post-procedure |
| Perceived dyspnea assessed via Borg Scale | Category rating scale to measure perceived dyspnea | 90 days post-procedure |
| Incidence of device related SAE(s) | 365 days |
| Any-cause mortality | Within 30 days |
| Symptomatic PE recurrence | Within 30 days |
| Cedars-Sinai Medical Center |
| Recruiting |
| Los Angeles |
| California |
| 90048 |
| United States |
| UCLA Medical Center | Recruiting | Los Angeles | California | 90095 | United States |
| UC Irvine Medical Center | Recruiting | Orange | California | 92868 | United States |
| UCSD Jacobs | Recruiting | San Diego | California | 92037 | United States |
| Sharp Memorial Hospital | Recruiting | San Diego | California | 92123 | United States |
| Christiana Care Hospital | Recruiting | Newark | Delaware | 19718 | United States |
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Manatee Memorial Hospital | Recruiting | Bradenton | Florida | 34205 | United States |
| Blake Medical Center/Nova Clinical Research | Recruiting | Brandenton | Florida | 34209 | United States |
| Delray Medical Center, Inc. | Recruiting | Delray Beach | Florida | 33484 | United States |
| University of Florida Shands Hospital | Recruiting | Gainesville | Florida | 32608 | United States |
| Radiology and Imaging Specialists | Recruiting | Lakeland | Florida | 33805 | United States |
| Jackson Memorial Hospital | Recruiting | Miami | Florida | 33136 | United States |
| Baptist Health Miami Cardiac and Vascular Institute | Recruiting | Miami | Florida | 33176 | United States |
| AdventHealth Orlando | Recruiting | Orlando | Florida | 32803 | United States |
| HCA Florida Northside Hospital | Recruiting | Petersburg | Florida | 33709 | United States |
| Tampa General Hospital | Recruiting | Tampa | Florida | 33606 | United States |
| St. Joseph Hospital - BayCare | Recruiting | Tampa | Florida | 33614 | United States |
| University Hospital Augusta | Recruiting | Augusta | Georgia | 30901 | United States |
| Memorial Hospital Belleville | Recruiting | Belleville | Illinois | 62226 | United States |
| Glenbrook Hospital | Recruiting | Glenview | Illinois | 60026 | United States |
| Loyola University Medical Center | Recruiting | Maywood | Illinois | 600153 | United States |
| KUMC | Completed | Kansas City | Kansas | 66160 | United States |
| LSU Health Sciences Center | Recruiting | Shreveport | Louisiana | 71103 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Charlton Memorial Hospital | Recruiting | Fall River | Massachusetts | 02720 | United States |
| Ascension St. John Hospital | Recruiting | Detroit | Michigan | 48236 | United States |
| University of Minnesota | Completed | Minneapolis | Minnesota | 55455 | United States |
| University of Mississippi Medical Center | Recruiting | Jackson | Mississippi | 39216 | United States |
| Mercy Hospital South | Recruiting | St Louis | Missouri | 63128 | United States |
| Cooper Health System | Recruiting | Camden | New Jersey | 08103 | United States |
| Lovelace Health System | Recruiting | Albuquerque | New Mexico | 87102 | United States |
| Bellevue Hospital Center | Recruiting | New York | New York | 10016 | United States |
| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
| Columbia University Medical Center/NYPH | Recruiting | New York | New York | 10032 | United States |
| St. Francis Hospital and Heart Center | Recruiting | Roslyn | New York | 11576 | United States |
| Staten Island University Hospital | Recruiting | Staten Island | New York | 10305 | United States |
| SUNY Upstate Medical University | Recruiting | Syracuse | New York | 13210 | United States |
| NC Heart and Vascular Research | Recruiting | Raleigh | North Carolina | 27607 | United States |
| Christ Hospital | Completed | Cincinnati | Ohio | 45219 | United States |
| TriHealth Good Samaritan Hospital | Recruiting | Cincinnati | Ohio | 45220 | United States |
| Mount Carmel East | Recruiting | Columbus | Ohio | 43213 | United States |
| Kettering Medical Center | Recruiting | Kettering | Ohio | 45429 | United States |
| ProMedica Toledo Hospital | Recruiting | Toledo | Ohio | 43606 | United States |
| INTEGRIS Baptist Medical Center | Recruiting | Oklahoma City | Oklahoma | 73112 | United States |
| Hillcrest Medical Center | Recruiting | Tulsa | Oklahoma | 74104 | United States |
| UPMC Harrisburg | Recruiting | Harrisburg | Pennsylvania | 17101 | United States |
| Penn State Health Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
| Temple University Hospital | Recruiting | Philadelphia | Pennsylvania | 19140 | United States |
| Miriam Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
| Jackson-Madison County General Hospital | Recruiting | Jackson | Tennessee | 38301 | United States |
| Turkey Creek Medical Center | Recruiting | Knoxville | Tennessee | 37934 | United States |
| Methodist Hospital Metropolitan | Recruiting | San Antonio | Texas | 78112 | United States |
| Houston Methodist The Woodlands Hospital | Recruiting | The Woodlands | Texas | 77385 | United States |
| Christus Mother Frances Hospital | Recruiting | Tyler | Texas | 75701 | United States |
| Sentara Norfolk General | Recruiting | Norfolk | Virginia | 23507 | United States |
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| Westmead Hospital | Recruiting | Westmead | New South Wales | 2145 | Australia |
| Flinders Medical Centre | Recruiting | Bedford Park | South Australia | 5043 | Australia |
| MedUni Graz-Univ.-Klinikum Graz | Recruiting | Graz | 8036 | Austria |
| Hospital Santa Lucia Sul | Recruiting | Brasília | 70390-700 | Brazil |
| Universitätsmedizin Mannheim | Recruiting | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Universitaetsmedizin Mainz | Recruiting | Mainz | 55131 | Germany |
| GRN-Klinik Weinheim | Completed | Weinheim | 69469 | Germany |
| Ospedale Misericordia | Recruiting | Grosseto | 58100 | Italy |
| Ospedale San Giovanni Bosco | Recruiting | Torino | 10154 | Italy |
| Leids Universitair Medisch Centrum | Recruiting | Leiden | 2333 ZA | Netherlands |
| Krakowski Szpital Specjalistyczny św. Jana Pawła II | Recruiting | Krakow | 31-202 | Poland |
| Europejskie Centrum Zdrowia Otwock | Recruiting | Otwock | 05-400 | Poland |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Recruiting | Poznan | 61-848 | Poland |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego | Recruiting | Warsaw | 02-005 | Poland |
| Hospital de Santa Cruz | Recruiting | Carnaxide | 2790-134 | Portugal |
| Hospital Universitario Virgen de la Nieves | Recruiting | Granada | 18014 | Spain |
| Hospital Clínico Universitario Lozano Blesa | Recruiting | Zaragoza | 50009 | Spain |
| Inselspital, Universitätsspital Bern | Recruiting | Bern | CH-3010 | Switzerland |
| Royal Sussex County Hospital | Recruiting | Brighton | Sussex | BN2 5BE | United Kingdom |
| University Hospital of Wales | Recruiting | Cardiff | Wales | CF14 4XW | United Kingdom |
| Royal Free Hospital | Recruiting | London | NW3 2QG | United Kingdom |
| 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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