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NCT04798261 · ClinicalTrials.gov registry record
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
A clinical trial of Pulmonary Embolism, sponsored by Penumbra.
- Recruiting
- Registry status
- 1,500
- Enrollment target
- 20
- Study locations
NCT04798261: Recruiting study of Pulmonary Embolism, sponsored by Penumbra.
NCT04798261 is a study of Pulmonary Embolism that is actively recruiting participants, run by Penumbra. The registered enrollment target is 1,500 participants, below the 3,027-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04798261, a study of Pulmonary Embolism, is actively recruiting participants, sponsored by Penumbra.
- RECRUITING
- Registry status
- 1,500 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury
Conditions Studied
Interventions
- DEVICE Indigo Aspiration System
Study Locations (20)
Florida
- Manatee Memorial Hospital - Bradenton
- Blake Medical Center/Nova Clinical Research - Brandenton
- Delray Medical Center, Inc. - Delray Beach
- University of Florida Shands Hospital - Gainesville
- Radiology and Imaging Specialists - Lakeland
- Jackson Memorial Hospital - Miami
- Baptist Health Miami Cardiac and Vascular Institute - Miami
- AdventHealth Orlando - Orlando
- HCA Florida Northside Hospital - Petersburg
- Tampa General Hospital - Tampa
- St. Joseph Hospital - BayCare - Tampa
California
- Long Beach Medical Center - Long Beach
- Cedars-Sinai Medical Center - Los Angeles
- UCLA Medical Center - Los Angeles
- UC Irvine Medical Center - Orange
- Sharp Memorial Hospital - San Diego
Illinois
- Memorial Hospital Belleville - Belleville
- Loyola University Medical Center - Maywood
Delaware
- Christiana Care Hospital - Newark
Georgia
- University Hospital Augusta - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2021-06-25 |
| Est. Completion | 2028-02 |
What NCT04798261 shows while recruiting
NCT04798261 is an observational study that tracks outcomes without assigning an intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, below the 3,027-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Pulmonary Embolism appearing as the primary indexed condition, and to 1 intervention - of which Indigo Aspiration System is the first listed.
NCT04798261 names 20 study sites across 5 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT04798261 about?
NCT04798261 is a clinical study titled "Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System". 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).
What is the current status of trial NCT04798261?
This trial is currently recruiting. The enrollment target is 1,500 participants. The study started on 2021-06-25. Estimated completion is 2028-02.
What conditions does trial NCT04798261 study?
This clinical trial studies the following conditions: Pulmonary Embolism.
What interventions are being tested in trial NCT04798261?
The interventions under investigation include: Indigo Aspiration System (DEVICE).
Who is sponsoring clinical trial NCT04798261?
This trial is sponsored by Penumbra, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04798261 being conducted?
This trial has 20 study locations across California, Delaware, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Embolism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04798261's enrollment target sits among peer trials
1,500 5th of 48 higher than 44 of 48 other Pulmonary Embolism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Embolism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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