Clinical trial NCT05003843: BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
Official title: BOLT: A Prospective, Multicenter Study of Patients With Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deep Vein Thrombosis
DVT
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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 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

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
* 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

Primary outcomes:
measure: Composite of Major Adverse Events
timeFrame: 48 Hours Post-Procedure
measure: Change in Marder Score
timeFrame: Index Procedure
Secondary outcomes:
measure: Composite of Major Adverse Events
timeFrame: 30 Days Post-Procedure
measure: Device Related Adverse Events
timeFrame: 24 Months
measure: Villalta Scale
timeFrame: 24 Months
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Sharp Grossmont
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Washington
country: United States
facility: MedStar Washington
state: District of Columbia
city: Jacksonville
country: United States
facility: Memorial Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Radiology and Imaging Specialists
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Miami
state: Florida
city: Miami
country: United States
facility: Baptist of Miami
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial
state: Florida
city: Belleville
country: United States
facility: Protestant Memorial Medical Center, Inc
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Lafayette
country: United States
facility: Lafayette General/Cardiovascular Institute of the South
state: Louisiana
city: Shreveport
country: United States
facility: LSU Hospital Shreveport
state: Louisiana
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Ann Arbor Hospital
state: Michigan
city: East Lansing
country: United States
facility: McLaren Greater Lansing
state: Michigan
city: Saint Louis
country: United States
facility: Jewish Barnes Hospital
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Heart
state: New Mexico
city: Buffalo
country: United States
facility: Kaleida University at Buffalo
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Mount Sinai NY
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: NYU
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth
state: Ohio
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: UPenn
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Kingsport
country: United States
facility: Holston Valley Medical
state: Tennessee
city: Dallas
country: United States
facility: BUMC - Dallas (Scott & White)
state: Texas
city: Norfolk
country: United States
facility: Sentara
state: Virginia
Study officials:
References: