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

NCT05003843 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2026-03-04

No results posted yet for this 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

  • Deep Vein Thrombosis
  • DVT

Interventions

DEVICE

Indigo Aspiration System

Indigo Aspiration System

Sponsors & Collaborators

  • Penumbra Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2025-11-18
Completion
2027-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05003843 on ClinicalTrials.gov