CATERPILLAR™ Arterial Embolization Device Study

NCT ID: NCT04090320

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2020-11-04

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.

Detailed Description

This feasibility study is a prospective, multi-center, single-arm study of the CATERPILLAR™ Arterial Embolization Device. Up to twenty (20) subjects will be treated with the CATERPILLAR™ Arterial Embolization Device at up to 5 investigational sites in New Zealand and Australia.

Conditions

Embolization, Therapeutic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CATERPILLAR™ Arterial Embolization Device

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

Group Type: EXPERIMENTAL

CATERPILLAR™ Arterial Embolization Device

Intervention Type: DEVICE

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

Interventions

CATERPILLAR™ Arterial Embolization Device

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

Intervention Type: DEVICE

Other Intervention Names

CATERPILLAR™ Micro (027); CATERPILLAR™ (038 & 056)

Eligibility Criteria

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.

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Holden, FRANZCR

Role: PRINCIPAL_INVESTIGATOR

Auckland City Hospital

Locations

Sydney Local Health District

Camperdown, New South Wales, Australia

Alfred Health

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Auckland Hospital

Auckland, , New Zealand

Clinical Trials New Zealand

Hamilton, , New Zealand

Countries

Australia; New Zealand

Other Identifiers

BPV-16-002

Identifier Type: -

Identifier Source: org_study_id