BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
- Conditions
- Deep Vein ThrombosisDVT
- Interventions
- Device: Indigo Aspiration System
- Registration Number
- NCT05003843
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 290
- 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
- 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
- Primary brain, metastatic cancer or marrow malignancies
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Indigo Aspiration System Use of Indigo Aspiration System in patients with obstruction due to DVT
- Primary Outcome Measures
Name Time Method Composite of Major Adverse Events 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
Change in Marder Score 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
Name Time Method Composite of Major Adverse Events 30 Days Post-Procedure A composite of death, major bleeding, new symptomatic pulmonary embolism or re-thrombus of the target venous segment
Device Related Adverse Events 24 Months Proportion of participants with device related adverse events
Villalta Scale 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.
Trial Locations
- Locations (41)
Sharp Grossmont
🇺🇸La Mesa, California, United States
UCLA
🇺🇸Los Angeles, California, United States
Christiana Care
🇺🇸Newark, Delaware, United States
MedStar Washington
🇺🇸Washington, District of Columbia, United States
Memorial Jacksonville
🇺🇸Jacksonville, Florida, United States
Radiology and Imaging Specialists
🇺🇸Lakeland, Florida, United States
Mount Sinai Miami
🇺🇸Miami Beach, Florida, United States
Baptist of Miami
🇺🇸Miami, 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
🇺🇸Saint 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