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

Study Overview
=================
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.

Official Title
-----------------
BOLT: A Prospective, Multicenter Study of Patients With Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System

Conditions
-----------------
Deep Vein Thrombosis, DVT

Intervention / Treatment
-----------------
* Device: Indigo Aspiration System


Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Use of Indigo Aspiration System in patients with obstruction due to DVT | Device: Indigo Aspiration System<br>* Indigo Aspiration System<br>|

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 |