Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING NA

BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis

NCT05003843 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 229 participants
Start Date 2021-09-30
Est. Completion 2027-02
Phase NA

Sponsor

Penumbra

9 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05003843

The ClinicalTrials.gov registry entry for NCT05003843 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 229 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penumbra, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05003843 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05003843?

The interventions under investigation include: Indigo Aspiration System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05003843?

This trial is sponsored by Penumbra, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial