Caterpillar™ Arterial Embolization Device Post-Market Study

Completed · Not applicable

Conditions studied: Embolization, Therapeutic

In brief

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.

Key facts

Study ID

NCT04244370

Run by

C. R. Bard

People needed

50

Starts

2020-04-30

Expected to finish

2022-08-12

Last updated by the study team

2023-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Angiographic Inclusion Criteria
• 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.

Where it is running

• Dignity Health/St. Joseph's & Medical Center — Phoenix, Arizona, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Kansas Medical Center Research Institute — Kansas City, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Minnesota Medical Center - Fairview — Minneapolis, Minnesota, United States
• Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Cardiothoracic and Vascular Surgeons — Austin, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• The Medical College of Wisconsin, Inc. — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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