Trials / Active Not Recruiting
Active Not RecruitingNCT05003843
BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
BOLT: A Prospective, Multicenter Study of Patients With Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 229 (actual)
- Sponsor
- Penumbra Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Indigo Aspiration System | Indigo Aspiration System |
Timeline
- Start date
- 2021-09-30
- Primary completion
- 2025-11-18
- Completion
- 2027-02-01
- First posted
- 2021-08-12
- Last updated
- 2026-03-04
Locations
42 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05003843. Inclusion in this directory is not an endorsement.