Clinical trial NCT04244370: Caterpillar™ Arterial Embolization Device Post-Market Study
Official title: A Prospective, Multi-Center, Single-Arm, Real World Study Assessing the Clinical Use of the Caterpillar™ Arterial Embolization Device for Arterial Embolization in the Peripheral Vasculature (MONARCH)
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: 2020-01-28
Enrollment: 50
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 in a real world, on-label application.

Detailed description: The post-market study is a prospective, multi-center, single-arm, real world study of the Caterpillar™ Arterial Embolization Device. Enrollment will continue until up to fifty (50) subjects have been treated with the Caterpillar™ Arterial Embolization Device at up to 20 investigational sites in the United States.

Eligibility criteria: Inclusion Criteria:

1. 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.
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: 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
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 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.
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: During the Index Procedure
measure: Freedom From Device-Related SAEs
timeFrame: 30 (-7/+21) Days post Index Procedure
Secondary outcomes:
measure: Time Point of Occlusion
timeFrame: During Index Procedure
measure: Freedom From Recanalization
timeFrame: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure
measure: Freedom From Acute Migration
timeFrame: During Index Procedure
measure: Freedom From Non-Acute Migration
timeFrame: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure
measure: Freedom From Device and/or Procedure-Related Adverse Events
timeFrame: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure
measure: Accuracy of Delivery
timeFrame: During Index Procedure
measure: Ease of Trackability/Deliverability
timeFrame: During Index Procedure
measure: Ease of Detachment
timeFrame: During Index Procedure
measure: Acceptability of Visibility Under Fluoroscopy
timeFrame: During Index Procedure
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dignity Health/St. Joseph's & Medical Center
state: Arizona
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center - Fairview
state: Minnesota
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin, Inc.
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: William Rilling, MD, FSIR
role: PRINCIPAL_INVESTIGATOR
References: