Clinical Trials in Italy / NCT04798261
Recruiting
Observational
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
NCT04798261 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Pulmonary Embolism
Investigational drug(s) / intervention(s)
Indigo Aspiration System
Indigo Aspiration System: Indigo Aspiration System
Study summary
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).
Eligibility
Inclusion Criteria:
1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
2. RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
3. Frontline endovascular treatment with the Indigo Aspiration System per IFU
4. Patient is ≥ 18 years of age
5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements
Exclusion Criteria:
1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
2. Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation
3. Known serious, uncontrolled sensitivity to radiographic agents
4. Life expectancy \< 180 days
5. Patients on ECMO
6. Pregnant patients
7. Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies
8. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Primary outcome measure(s)
- Safety: Composite of major adverse events — 48 hours
A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury - Performance: Change in RV/LV Ratio — 48 hours post-procedure
Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available)
Trial sites (79)
| Facility | City | Region | Status |
|---|---|---|---|
| Long Beach Medical Center | Long Beach | California | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | Recruiting |
| UCLA Medical Center | Los Angeles | California | Recruiting |
| UC Irvine Medical Center | Orange | California | Recruiting |
| UCSD Jacobs | San Diego | California | Recruiting |
| Sharp Memorial Hospital | San Diego | California | Recruiting |
| Christiana Care Hospital | Newark | Delaware | Recruiting |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | Recruiting |
| Manatee Memorial Hospital | Bradenton | Florida | Recruiting |
| Blake Medical Center/Nova Clinical Research | Brandenton | Florida | Recruiting |
| Delray Medical Center, Inc. | Delray Beach | Florida | Recruiting |
| University of Florida Shands Hospital | Gainesville | Florida | Recruiting |
| Radiology and Imaging Specialists | Lakeland | Florida | Recruiting |
| Jackson Memorial Hospital | Miami | Florida | Recruiting |
| Baptist Health Miami Cardiac and Vascular Institute | Miami | Florida | Recruiting |
| AdventHealth Orlando | Orlando | Florida | Recruiting |
| HCA Florida Northside Hospital | Petersburg | Florida | Recruiting |
| Tampa General Hospital | Tampa | Florida | Recruiting |
| St. Joseph Hospital - BayCare | Tampa | Florida | Recruiting |
| University Hospital Augusta | Augusta | Georgia | Recruiting |
| Memorial Hospital Belleville | Belleville | Illinois | Recruiting |
| Glenbrook Hospital | Glenview | Illinois | Recruiting |
| Loyola University Medical Center | Maywood | Illinois | Recruiting |
| KUMC | Kansas City | Kansas | Completed |
| LSU Health Sciences Center | Shreveport | Louisiana | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Charlton Memorial Hospital | Fall River | Massachusetts | Recruiting |
| Ascension St. John Hospital | Detroit | Michigan | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | Completed |
| University of Mississippi Medical Center | Jackson | Mississippi | Recruiting |
| Mercy Hospital South | St Louis | Missouri | Recruiting |
| Cooper Health System | Camden | New Jersey | Recruiting |
| Lovelace Health System | Albuquerque | New Mexico | Recruiting |
| Bellevue Hospital Center | New York | New York | Recruiting |
| Mount Sinai Hospital | New York | New York | Recruiting |
| Columbia University Medical Center/NYPH | New York | New York | Recruiting |
| St. Francis Hospital and Heart Center | Roslyn | New York | Recruiting |
| Staten Island University Hospital | Staten Island | New York | Recruiting |
| SUNY Upstate Medical University | Syracuse | New York | Recruiting |
| NC Heart and Vascular Research | Raleigh | North Carolina | Recruiting |
+ 39 more sites — see the full list on the official registry below.
More Penumbra Inc. trials in Italy
Other trials for the same condition
Inari VISION Registry
Recruiting
Pulmonary Embolism International THrOmbolysis Study-3
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04798261 on ClinicalTrials.gov ↗ ← All trials in Italy