CATERPILLAR™ Arterial Embolization Device Study

NCT04090320 | Completed

• 1 other identifier: BPV-16-002
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 5

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.

Conditions

Embolization, Therapeutic

Keywords

Arterial Embolization; Vascular Plug

Outcome Measures

Primary Outcomes (2)

• Technical Success

  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.

  Index Procedure.

• Freedom from Device-Related SAEs

  Freedom from Device-Related Serious Adverse Events (SAE) through 30 day follow-up.

  30 (-7/+21) Days

Secondary Outcomes (5)

• Time Point of Occlusion

  Index Procedure

• Freedom from Recanalization

  30 (-7/+21) Days

• Freedom from Migration

  30 (-7/+21) Days

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

  30 (-7/+21) Days

• Investigator Satisfaction

  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 must voluntarily sign and date the approved Informed Consent Form (ICF) prior to collection of study data or performance of study 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: More than one target embolization site may be treated 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 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.
• 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 (5)

Sydney Local Health District

Camperdown, New South Wales, Australia

Location

Alfred Health

Melbourne, Victoria, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Auckland Hospital

Auckland, New Zealand

Location

Clinical Trials New Zealand

Hamilton, New Zealand

Location

Study Officials

• Andrew Holden, FRANZCR

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

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: September 12, 2019
• First Posted: September 16, 2019
• Study Start: September 25, 2019
• Primary Completion: November 4, 2020
• Study Completion: November 4, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); AU (3)