Clinical trial NCT04090320: CATERPILLAR™ Arterial Embolization Device Study
Official title: A Prospective, Multi-Center, Single-Arm Study Assessing the Clinical Use of the CATERPILLAR™ Arterial Embolization Device System for Arterial Embolization in the Peripheral Vasculature (CHRYSALIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embolization, Therapeutic
Keywords: Arterial Embolization
Vascular Plug
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2019-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Technical Success
timeFrame: Index Procedure.
measure: Freedom from Device-Related SAEs
timeFrame: 30 (-7/+21) Days
Secondary outcomes:
measure: Time Point of Occlusion
timeFrame: Index Procedure
measure: Freedom from Recanalization
timeFrame: 30 (-7/+21) Days
measure: Freedom from Migration
timeFrame: 30 (-7/+21) Days
measure: Freedom from Device and/or Procedure-Related Adverse Events
timeFrame: 30 (-7/+21) Days
measure: Investigator Satisfaction
timeFrame: Index Procedure
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Sydney Local Health District
state: New South Wales
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Auckland
country: New Zealand
facility: Auckland Hospital
city: Hamilton
country: New Zealand
facility: Clinical Trials New Zealand
Study officials:
affiliation: Auckland City Hospital
name: Andrew Holden, FRANZCR
role: PRINCIPAL_INVESTIGATOR
References: