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)

C. R. Bard11 sites in 1 country50 target enrollmentApril 30, 2020

ConditionsEmbolization, Therapeutic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Embolization, Therapeutic
Sponsor: C. R. Bard
Enrollment: 50
Locations: 11
Primary Endpoint: Freedom From Device-Related SAEs
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 30, 2020

End Date

August 12, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

C. R. Bard

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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: 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
•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.

Exclusion Criteria

•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 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.
•The subject has a known uncontrolled blood coagulation or bleeding disorder.
•The subject has an unresolved systemic infection.

Outcomes

Primary Outcomes

Freedom From Device-Related SAEs

Time Frame: 30 (-7/+21) Days post Index Procedure

Freedom from device-related serious adverse events (SAE) through 30-day follow-up.

Technical Success

Time Frame: During the Index Procedure

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.

Secondary Outcomes

Time Point of Occlusion(During Index Procedure)
Freedom From Acute Migration(During Index Procedure)
Freedom From Non-Acute Migration(30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure)
Freedom From Device and/or Procedure-Related Adverse Events(30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure)
Freedom From Recanalization(30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure)
Accuracy of Delivery(During Index Procedure)
Ease of Trackability/Deliverability(During Index Procedure)
Ease of Detachment(During Index Procedure)
Acceptability of Visibility Under Fluoroscopy(During Index Procedure)