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ACTIVE NOT RECRUITING
NCT05003843
NA

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

Sponsor: Penumbra Inc.

View on ClinicalTrials.gov

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.

Official title: BOLT: A Prospective, Multicenter Study of Patients With Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

229

Start Date

2021-09-30

Completion Date

2027-02

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DEVICE

Indigo Aspiration System

Indigo Aspiration System

Locations (42)

Sharp Grossmont

La Mesa, California, United States

Long Beach Medical Center

Long Beach, California, United States

UCLA

Los Angeles, California, United States

Christiana Care

Newark, Delaware, United States

MedStar Washington

Washington D.C., District of Columbia, United States

Memorial Jacksonville

Jacksonville, Florida, United States

Radiology and Imaging Specialists

Lakeland, Florida, United States

Baptist of Miami

Miami, Florida, United States

Mount Sinai Miami

Miami Beach, Florida, United States

Sarasota Memorial

Sarasota, Florida, United States

Protestant Memorial Medical Center, Inc

Belleville, Illinois, United States

Northwestern Memorial

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

St. Vincent

Indianapolis, Indiana, United States

Indiana University Health

Indianapolis, Indiana, United States

University of Kentucky

Lexington, Kentucky, United States

Lafayette General/Cardiovascular Institute of the South

Lafayette, Louisiana, United States

LSU Hospital Shreveport

Shreveport, Louisiana, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

St. Joseph Mercy Ann Arbor Hospital

Ann Arbor, Michigan, United States

McLaren Greater Lansing

East Lansing, Michigan, United States

Jewish Barnes Hospital

St Louis, Missouri, United States

Nebraska Methodist

Omaha, Nebraska, United States

Hackensack Medical Center

Hackensack, New Jersey, United States

Lovelace Heart

Albuquerque, New Mexico, United States

Kaleida University at Buffalo

Buffalo, New York, United States

Weill Cornell Medicine

New York, New York, United States

Mount Sinai NY

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

NYU

New York, New York, United States

Stony Brook University

Stony Brook, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

NC Heart and Vascular Research

Raleigh, North Carolina, United States

Christ Cincinnati

Cincinnati, Ohio, United States

TriHealth

Cincinnati, Ohio, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

UPenn

Philadelphia, Pennsylvania, United States

MUSC

Charleston, South Carolina, United States

Holston Valley Medical

Kingsport, Tennessee, United States

BUMC - Dallas (Scott & White)

Dallas, Texas, United States

Sentara

Norfolk, Virginia, United States