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

Status: Recruiting
Location: See all (42) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Unilateral lower extremity DVT occlusion involving iliac and/or common femoral veins with up to 2 cm extension in the inferior vena cava (IVC) or femoral in combination with iliac veins, including patients with extension of clot into the contralateral common iliac vein Note: Patients with non-iliofemoral DVT in the contralateral limb, who do not require endovascular treatment, may be enrolled

• Acute thrombotic or thromboembolic occlusion with symptom duration of 14 days or less at presentation

• Frontline treatment with Indigo Aspiration System in the target venous segment per Investigator decision

• Patient is ≥18 years of age

• Informed consent is obtained per Institutional Review Board requirements

Locations
United States
California
Sharp Grossmont
RECRUITING
La Mesa
Long Beach Medical Center
RECRUITING
Long Beach
UCLA
COMPLETED
Los Angeles
Washington, D.c.
MedStar Washington
RECRUITING
Washington D.c.
Delaware
Christiana Care
RECRUITING
Newark
Florida
Memorial Jacksonville
RECRUITING
Jacksonville
Radiology and Imaging Specialists
RECRUITING
Lakeland
Baptist of Miami
RECRUITING
Miami
Mount Sinai Miami
RECRUITING
Miami Beach
Sarasota Memorial
RECRUITING
Sarasota
Illinois
Protestant Memorial Medical Center, Inc
RECRUITING
Belleville
Northwestern Memorial
RECRUITING
Chicago
Rush University Medical Center
RECRUITING
Chicago
Indiana
Indiana University Health
COMPLETED
Indianapolis
St. Vincent
RECRUITING
Indianapolis
Kentucky
University of Kentucky
RECRUITING
Lexington
Louisiana
Lafayette General/Cardiovascular Institute of the South
RECRUITING
Lafayette
LSU Hospital Shreveport
RECRUITING
Shreveport
Massachusetts
UMass Memorial Medical Center
RECRUITING
Worcester
Michigan
St. Joseph Mercy Ann Arbor Hospital
COMPLETED
Ann Arbor
University of Michigan
COMPLETED
Ann Arbor
McLaren Greater Lansing
RECRUITING
East Lansing
Missouri
Jewish Barnes Hospital
RECRUITING
St Louis
North Carolina
Duke University Medical Center
RECRUITING
Durham
NC Heart and Vascular Research
RECRUITING
Raleigh
Nebraska
Nebraska Methodist
COMPLETED
Omaha
New Jersey
Hackensack Medical Center
RECRUITING
Hackensack
New Mexico
Lovelace Heart
RECRUITING
Albuquerque
New York
Kaleida University at Buffalo
RECRUITING
Buffalo
Lenox Hill Hospital
RECRUITING
New York
Mount Sinai NY
RECRUITING
New York
NYU
RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
Stony Brook University
RECRUITING
Stony Brook
Ohio
Christ Cincinnati
RECRUITING
Cincinnati
TriHealth
RECRUITING
Cincinnati
Pennsylvania
Lancaster General Hospital
RECRUITING
Lancaster
UPenn
RECRUITING
Philadelphia
South Carolina
MUSC
RECRUITING
Charleston
Tennessee
Holston Valley Medical
RECRUITING
Kingsport
Texas
BUMC - Dallas (Scott & White)
RECRUITING
Dallas
Virginia
Sentara
RECRUITING
Norfolk
Contact Information
Primary
Aisha Pascua
apascua@penumbrainc.com
+1 415-601-9561
Backup
Erin Archard
earchard@penumbrainc.com
+1 802-377-9715
Time Frame
Start Date: 2021-09-30
Estimated Completion Date: 2027-02
Participants
Target number of participants: 290
Treatments
Other: Single Arm
Use of Indigo Aspiration System in patients with obstruction due to DVT
Sponsors
Leads: Penumbra Inc.

This content was sourced from clinicaltrials.gov