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NCT05003843 · ClinicalTrials.gov registry record · NA
BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
A NA study of Deep Vein Thrombosis and DVT, sponsored by Penumbra.
- Active
- Registry status
- NA
- Development phase
- 229
- Enrollment target
- 20
- Study locations
NCT05003843: Active NA study of Deep Vein Thrombosis and DVT, sponsored by Penumbra.
NCT05003843 is a NA study of Deep Vein Thrombosis and DVT that is active but no longer recruiting, run by Penumbra. The registered enrollment target is 229 participants, below the 7,922-participant average among 24 other Deep Vein Thrombosis trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05003843, a NA study of Deep Vein Thrombosis and DVT, is active but no longer recruiting, sponsored by Penumbra.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 229 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment.
Primary Outcome
Device related death, major bleeding, new symptomatic pulmonary embolism or re-thrombosis of the target venous segment and serious device related events
Conditions Studied
Interventions
- DEVICE Indigo Aspiration System
Study Locations (20)
Florida
- Memorial Jacksonville - Jacksonville
- Radiology and Imaging Specialists - Lakeland
- Baptist of Miami - Miami
- Mount Sinai Miami - Miami Beach
- Sarasota Memorial - Sarasota
California
- Sharp Grossmont - La Mesa
- Long Beach Medical Center - Long Beach
- UCLA - Los Angeles
Illinois
- Protestant Memorial Medical Center, Inc - Belleville
- Northwestern Memorial - Chicago
- Rush University Medical Center - Chicago
Indiana
- St. Vincent - Indianapolis
- Indiana University Health - Indianapolis
Louisiana
- Lafayette General/Cardiovascular Institute of the South - Lafayette
- LSU Hospital Shreveport - Shreveport
Delaware
- Christiana Care - Newark
District of Columbia
- MedStar Washington - Washington D.C.
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2021-09-30 |
| Est. Completion | 2027-02 |
| Phase | NA |
What the registry record for NCT05003843 still lists
NCT05003843 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, below the 7,922-participant average among 24 other Deep Vein Thrombosis trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Deep Vein Thrombosis appearing as the primary indexed condition, and to 1 intervention - of which Indigo Aspiration System is the first listed.
NCT05003843 names 20 study sites across 10 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05003843 about?
NCT05003843 is a clinical study titled "BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis". The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment.
What is the current status of trial NCT05003843?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 229 participants. The study started on 2021-09-30. Estimated completion is 2027-02.
What conditions does trial NCT05003843 study?
This clinical trial studies the following conditions: Deep Vein Thrombosis, DVT.
What interventions are being tested in trial NCT05003843?
The interventions under investigation include: Indigo Aspiration System (DEVICE).
Who is sponsoring clinical trial NCT05003843?
This trial is sponsored by Penumbra, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05003843 being conducted?
This trial has 20 study locations across California, Delaware, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Deep Vein Thrombosis
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 NCT05003843's enrollment target sits among peer trials
229 13th of 24 higher than 12 of 24 other Deep Vein Thrombosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Deep Vein Thrombosis 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.
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