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BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
Sponsor: Penumbra Inc.
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
Conditions
Interventions
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