Indigo Aspiration System: Indigo Aspiration System
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
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.
Trial sites (42)
Facility
City
Region
Status
Sharp Grossmont
La Mesa
California
Long Beach Medical Center
Long Beach
California
UCLA
Los Angeles
California
Christiana Care
Newark
Delaware
MedStar Washington
Washington D.C.
District of Columbia
Memorial Jacksonville
Jacksonville
Florida
Radiology and Imaging Specialists
Lakeland
Florida
Baptist of Miami
Miami
Florida
Mount Sinai Miami
Miami Beach
Florida
Sarasota Memorial
Sarasota
Florida
Protestant Memorial Medical Center, Inc
Belleville
Illinois
Northwestern Memorial
Chicago
Illinois
Rush University Medical Center
Chicago
Illinois
St. Vincent
Indianapolis
Indiana
Indiana University Health
Indianapolis
Indiana
University of Kentucky
Lexington
Kentucky
Lafayette General/Cardiovascular Institute of the South
Lafayette
Louisiana
LSU Hospital Shreveport
Shreveport
Louisiana
UMass Memorial Medical Center
Worcester
Massachusetts
University of Michigan
Ann Arbor
Michigan
St. Joseph Mercy Ann Arbor Hospital
Ann Arbor
Michigan
McLaren Greater Lansing
East Lansing
Michigan
Jewish Barnes Hospital
St Louis
Missouri
Nebraska Methodist
Omaha
Nebraska
Hackensack Medical Center
Hackensack
New Jersey
Lovelace Heart
Albuquerque
New Mexico
Kaleida University at Buffalo
Buffalo
New York
Weill Cornell Medicine
New York
New York
Mount Sinai NY
New York
New York
Lenox Hill Hospital
New York
New York
NYU
New York
New York
Stony Brook University
Stony Brook
New York
Duke University Medical Center
Durham
North Carolina
NC Heart and Vascular Research
Raleigh
North Carolina
Christ Cincinnati
Cincinnati
Ohio
TriHealth
Cincinnati
Ohio
Lancaster General Hospital
Lancaster
Pennsylvania
UPenn
Philadelphia
Pennsylvania
MUSC
Charleston
South Carolina
Holston Valley Medical
Kingsport
Tennessee
+ 2 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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