RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-09-30
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05003843

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Acute thrombotic or thromboembolic occlusion with symptom duration of 14 days or less at presentation
  3. * Frontline treatment with Indigo Aspiration System in the target venous segment per Investigator decision
  4. * Patient is ≥18 years of age
  5. * Informed consent is obtained per Institutional Review Board requirements
  1. * Contraindication to systemic or therapeutic doses of anticoagulants
  2. * Contraindication to iodinated contrast venography that cannot be adequately premedicated
  3. * Complete infrarenal IVC occlusion
  4. * In the index leg: prior DVT
  5. * Prior stent in target venous segment
  6. * Treatment of index DVT with thrombolytics within 14 days prior to index procedure
  7. * 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.
  8. * Known coagulation disorders both acquired (e.g., Heparin Induced Thrombocytopenia, etc.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable state
  9. * Pregnant patients
  10. * Life expectancy \<1 year due to comorbidities
  11. * 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
  12. * 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.
  13. * 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
  14. * 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
  15. * Congenital anatomic anomalies of the IVC or iliac veins

Contacts and Locations

Study Contact

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Penumbra Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-30
Study Completion Date2027-02

Study Record Updates

Study Start Date2021-09-30
Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

  • Deep Vein Thrombosis
  • DVT