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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05003843
Recruitment Status : Recruiting
First Posted : August 12, 2021
Last Update Posted : June 8, 2022
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis DVT Device: Indigo Aspiration System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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
Actual Study Start Date : September 30, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Single Arm
Use of Indigo Aspiration System in patients with obstruction due to DVT
Device: Indigo Aspiration System
Indigo Aspiration System




Primary Outcome Measures :
  1. Composite of Major Adverse Events [ Time Frame: 48 Hours Post-Procedure ]
    Device related death, major bleeding, new symptomatic pulmonary embolism or re-thrombosis of the target venous segment and serious device related events

  2. Change in Marder Score [ Time Frame: Index Procedure ]

    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.



Secondary Outcome Measures :
  1. Composite of Major Adverse Events [ Time Frame: 30 Days Post-Procedure ]
    A composite of death, major bleeding, new symptomatic pulmonary embolism or re-thrombus of the target venous segment

  2. Device Related Adverse Events [ Time Frame: 24 Months ]
    Proportion of participants with device related adverse events

  3. Villalta Scale [ Time Frame: 24 Months ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 caval or iliofemoral device (e.g. IVC filter, stent obstruction, etc.)
  • Congenital anatomic anomalies of the IVC or iliac veins

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05003843


Contacts
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Contact: Aisha Pascua +1 415-601-9561 apascua@penumbrainc.com
Contact: Erin Archard +1 802-377-9715 earchard@penumbrainc.com

Locations
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United States, Delaware
Christiana Care Recruiting
Newark, Delaware, United States, 19713
Sponsors and Collaborators
Penumbra Inc.
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Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT05003843    
Other Study ID Numbers: 19458
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases