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

Deep Vein Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05003843
• Other study ID #: 19458
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: February 2027

Study information

• Verified date: March 2024
• Source: Penumbra Inc.
• Contact: Aisha Pascua
• Phone: +1 415-601-9561
• Email: apascua[@]penumbrainc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: February 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• DVT
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• Indigo Aspiration System
Indigo Aspiration System

Locations

Country	Name	City	State
United States	Lovelace Heart	Albuquerque	New Mexico
United States	St. Joseph Mercy Ann Arbor Hospital	Ann Arbor	Michigan
United States	University of Michigan	Ann Arbor	Michigan
United States	Protestant Memorial Medical Center, Inc	Belleville	Illinois
United States	Kaleida University at Buffalo	Buffalo	New York
United States	MUSC	Charleston	South Carolina
United States	Northwestern Memorial	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Christ Cincinnati	Cincinnati	Ohio
United States	TriHealth	Cincinnati	Ohio
United States	BUMC - Dallas (Scott & White)	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	McLaren Greater Lansing	East Lansing	Michigan
United States	Hackensack Medical Center	Hackensack	New Jersey
United States	Indiana University Health	Indianapolis	Indiana
United States	St. Vincent	Indianapolis	Indiana
United States	Memorial Jacksonville	Jacksonville	Florida
United States	Holston Valley Medical	Kingsport	Tennessee
United States	Sharp Grossmont	La Mesa	California
United States	Lafayette General/Cardiovascular Institute of the South	Lafayette	Louisiana
United States	Radiology and Imaging Specialists	Lakeland	Florida
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	University of Kentucky	Lexington	Kentucky
United States	UCLA	Los Angeles	California
United States	Baptist of Miami	Miami	Florida
United States	Mount Sinai Miami	Miami Beach	Florida
United States	Lenox Hill Hospital	New York	New York
United States	Mount Sinai NY	New York	New York
United States	NYU	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Christiana Care	Newark	Delaware
United States	Sentara	Norfolk	Virginia
United States	Nebraska Methodist	Omaha	Nebraska
United States	UPenn	Philadelphia	Pennsylvania
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	Jewish Barnes Hospital	Saint Louis	Missouri
United States	Sarasota Memorial	Sarasota	Florida
United States	LSU Hospital Shreveport	Shreveport	Louisiana
United States	Stony Brook University	Stony Brook	New York
United States	MedStar Washington	Washington	District of Columbia
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Device Related Adverse Events	Proportion of participants with device related adverse events	24 Months
Secondary	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