Caterpillar™ Arterial Embolization Device Post-Market Study

NCT04244370 | Completed Results FDA Device

• 1 other identifier: BPV-18-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 11

Brief Summary

The primary objective of this study is to evaluate the performance and safety of the Caterpillar™ Arterial Embolization Device when used for arterial embolization in the peripheral vasculature in a real world, on-label application.

Conditions

Embolization, Therapeutic

Keywords

Arterial Embolization; Vascular Plug

Outcome Measures

Primary Outcomes (2)

• Technical Success

  Successful occlusion of the target embolization site(s) as confirmed by the Investigator via angiographic assessment during the Index Procedure. Technical success will be reported for each target embolization site.

  During the Index Procedure

• Freedom From Device-Related SAEs

  Freedom from device-related serious adverse events (SAE) through 30-day follow-up.

  30 (-7/+21) Days post Index Procedure

Secondary Outcomes (9)

• Time Point of Occlusion

  During Index Procedure

• Freedom From Recanalization

  30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure

• Freedom From Acute Migration

  During Index Procedure

• Freedom From Non-Acute Migration

  30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure

• Freedom From Device and/or Procedure-Related Adverse Events

  30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure

Study Arms (1)

Caterpillar™ Arterial Embolization Device

EXPERIMENTAL

Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).

Device: Caterpillar™ Arterial Embolization Device

Interventions

Caterpillar™ Arterial Embolization Device DEVICE

Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.

Also known as: Caterpillar™ Micro (027), Caterpillar™ (038 & 056)

Caterpillar™ Arterial Embolization Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject or Legally Authorized Representative (LAR) must voluntarily sign and date the approved Informed Consent Form (ICF) prior to collection of study-specific data or performance of study-specific procedures.
• Subject must be either male or non-pregnant female ≥18 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
• Subject must be willing and able to comply with protocol requirements, including all study visits and procedures.
• Subject must require peripheral vascular occlusion at an arterial target embolization site(s) that can be treated with the Caterpillar™ Arterial Embolization Device according to the Instructions for Use (IFU). Note: Per Investigator discretion, up to five (5) Target Embolization Sites may be treated with up to ten (10) study devices per subject.
• The target embolization site(s) must be located in a native arterial vessel(s) with the intended arterial vessel diameter ranges shown in the IFU, as assessed by the Investigator (via visual estimate).
• The target embolization site(s) must have a landing zone sufficient to accommodate the device implant lengths shown in the IFU.

You may not qualify if:

• The subject's access vessel(s) preclude safe insertion of the delivery catheter.
• The subject's target embolization site(s) is located within a vein.
• The subject's target embolization site(s) is located within the head, neck, heart or coronary vessels.
• The subject's target embolization site(s) is located across highly locomotive joints or muscle beds (e.g. elbow, hip, knee, shoulder, thoracic inlet/outlet).
• The subject's target embolization site(s) is located in a high-flow vessel where, in the opinion of the Investigator, there may be significant risk of migration and unintended (non-target site) occlusion.
• The subject has a known allergy or hypersensitivity to contrast media that cannot be adequately pre-medicated.
• The subject has a known allergy or hypersensitivity to any of the device materials including: cobalt, chromium, nickel, titanium, platinum, iridium, polyurethane or polyethylene.
• The subject has planned use of anticoagulant (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy before, during and/or after treatment with the study device, which, in the opinion of the Investigator, would clinically interfere with the study endpoints.
• The subject has a known uncontrolled blood coagulation or bleeding disorder.
• The subject has an unresolved systemic infection.
• The subject's required pre-operative laboratory tests and/or physical examination indicate abnormal results, which, in the opinion of the Investigator, would clinically interfere with the study endpoints.
• The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder, which, in the opinion of the Investigator, would clinically interfere with the study endpoints.
• The subject has another medical condition which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, may confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
• The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (11)

Dignity Health/St. Joseph's & Medical Center

Phoenix, Arizona, 85013, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center Research Institute

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Minnesota Medical Center - Fairview

Minneapolis, Minnesota, 55455, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

The Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, 53226, United States

Location

Results Point of Contact

• Title: Heather Vander Ploeg
• Organization: BD

heather.vander.ploeg@bd.com

602-751-3268

Study Officials

• William Rilling, MD, FSIR

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 28, 2020
• Study Start: April 30, 2020
• Primary Completion: August 13, 2021
• Study Completion: August 12, 2022
• Last Updated: July 25, 2023
• Results First Posted: October 12, 2022

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)