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

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.

Study Overview

• Status: Recruiting
• Conditions: Deep Vein Thrombosis; DVT
• Intervention / Treatment: Device: Indigo Aspiration System

• Study Type: Interventional
• Enrollment (Estimated): 290
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aisha Pascua; Phone Number: +1 415-601-9561; Email: apascua@penumbrainc.com
• Study Contact Backup: Name: Erin Archard; Phone Number: +1 802-377-9715; Email: earchard@penumbrainc.com

Study Locations

• United States
  • California
    • La Mesa, California, United States, 91942
      • Recruiting
      • Sharp Grossmont
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • Christiana Care
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • MedStar Washington
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Recruiting
      • Memorial Jacksonville
    • Lakeland, Florida, United States, 33805
      • Recruiting
      • Radiology and Imaging Specialists
    • Miami, Florida, United States, 33176
      • Recruiting
      • Baptist of Miami
    • Miami Beach, Florida, United States, 33140
      • Recruiting
      • Mount Sinai Miami
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Sarasota Memorial
  • Illinois
    • Belleville, Illinois, United States, 62226
      • Recruiting
      • Protestant Memorial Medical Center, Inc
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Memorial
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • St. Vincent
    • Indianapolis, Indiana, United States, 46290
      • Recruiting
      • Indiana University Health
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University of Kentucky
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Recruiting
      • Lafayette General/Cardiovascular Institute of the South
    • Shreveport, Louisiana, United States, 71103
      • Recruiting
      • LSU Hospital Shreveport
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • UMASS Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
    • Ann Arbor, Michigan, United States, 48197
      • Recruiting
      • St. Joseph Mercy Ann Arbor Hospital
    • East Lansing, Michigan, United States, 48910
      • Recruiting
      • Mclaren Greater Lansing
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Jewish Barnes Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68118
      • Recruiting
      • Nebraska Methodist
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Hackensack Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Recruiting
      • Lovelace Heart
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • Kaleida University at Buffalo
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medicine
    • New York, New York, United States, 10075
      • Recruiting
      • Lenox Hill Hospital
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai NY
    • New York, New York, United States, 11220
      • Recruiting
      • NYU
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • NC Heart and Vascular Research
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • TriHealth
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • Christ Cincinnati
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
      • Recruiting
      • Lancaster General Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • UPenn
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • MUSC
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Recruiting
      • Holston Valley Medical
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • BUMC - Dallas (Scott & White)
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Sentara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• Contraindication to systemic or therapeutic doses of anticoagulants
• Contraindication to iodinated contrast venography that cannot be adequately premedicated
• Complete infrarenal IVC occlusion
• In the index leg: prior DVT
• Prior stent in target venous segment
• Treatment of index DVT with thrombolytics within 14 days prior to index procedure
• Pulmonary embolism (PE) defined as either high (systolic blood pressure < 90 mmHg and/or patient on IV vasoactive medication to support blood pressure), or intermediate high-risk PE, as defined by the European Society Guideline on management of PE. Low risk PE and/or intermediate low risk PE can be enrolled.
• Known coagulation disorders both acquired (e.g., Heparin Induced Thrombocytopenia, etc.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable state
• Pregnant patients
• Life expectancy <1 year due to comorbidities
• Active cancer: metastatic, progressive, or treated with chemotherapy or radiation therapy in the last 6 months, with the exception of patients with non-melanoma primary skin cancers
• Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
• Other medical, behavioral, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
• Pre-existing malpositioned stent(s) that obstructs the ostium of the index iliac vein and contacts the vena cava wall as demonstrated by venography prior to the index procedure
• Congenital anatomic anomalies of the IVC or iliac veins

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm; Use of Indigo Aspiration System in patients with obstruction due to DVT	Device: Indigo Aspiration System; Indigo Aspiration System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Major Adverse Events	Device related death, major bleeding, new symptomatic pulmonary embolism or re-thrombosis of the target venous segment and serious device related events	48 Hours Post-Procedure
Change in Marder Score	Complete or near complete (75% or greater) reduction of venous thrombus from the target venous segment as measured by Marder Score pre- to post-procedure The Marder Score ranges from 0 to 24, with higher scores being worse.	Index Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Major Adverse Events	A composite of death, major bleeding, new symptomatic pulmonary embolism or re-thrombus of the target venous segment	30 Days Post-Procedure
Device Related Adverse Events	Proportion of participants with device related adverse events	24 Months
Villalta Scale	Villalta scores reported at baseline, 30 days, 180 days, 12 months, and 24 months Villalta score ranges from 0 (no post thrombotic syndrome) to 33 (severe post thrombotic syndrome), with higher scores being worse.	24 Months

Collaborators and Investigators

• Sponsor: Penumbra Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: 19458

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes