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CATERPILLAR™ Arterial Embolization Device Study

Sponsored by C. R. Bard

About this trial

Last updated 4 years ago

Study ID

BPV-16-002

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 5 years ago

What is this trial about?

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.

What are the Participation Requirements?

Clinical Inclusion Criteria:

1. Subject must voluntarily sign and date the approved Informed Consent Form (ICF)
prior to collection of study data or performance of study procedures.

2. 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.

3. Subject must be willing and able to comply with protocol requirements, including all
study visits and procedures.

4. 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: More than one target
embolization site may be treated per subject.

Angiographic Inclusion Criteria:

5. 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).

6. The target embolization site(s) must have a landing zone sufficient to accommodate
the device implant lengths shown in the IFU.

Clinical Exclusion Criteria:

1. The subject's access vessel(s) preclude safe insertion of the delivery catheter.

2. The subject's target embolization site(s) is located within a vein.

3. The subject's target embolization site(s) is located within the head, neck, heart or
coronary vessels.

4. 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).

5. 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.

6. The subject has a known allergy or hypersensitivity to contrast media that cannot be
adequately pre-medicated.

7. The subject has a known allergy or hypersensitivity to any of the device materials
including: cobalt, chromium, nickel, titanium, platinum, iridium, polyurethane or
polyethylene.

8. The subject will receive anticoagulant or antiplatelet therapy (e.g. direct thrombin
inhibitors, factor Xa inhibitors, vitamin K antagonists) before, during and/or after
treatment with the study device, which, in the opinion of the Investigator, would
clinically interfere with the study endpoints.

9. The subject has a known uncontrolled blood coagulation or bleeding disorder.

10. The subject has an unresolved systemic infection.

11. 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.

12. 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.

13. 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.

14. 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.

Locations

Location

Status