Caterpillar™ Arterial Embolization Device Post-Market Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Embolization, Therapeutic

Intervention / Treatment
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* Device: Caterpillar™ Arterial Embolization Device


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caterpillar™ Arterial Embolization Device<br>Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE). | Device: Caterpillar™ Arterial Embolization Device<br>* Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.<br>* Other names: Caterpillar™ (038 & 056);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the Index Procedure | 
| Freedom From Device-Related SAEs | Freedom from device-related serious adverse events (SAE) through 30-day follow-up. | 30 (-7/+21) Days post Index Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Point of Occlusion | The percentage of target embolization site(s) with occlusion at ≤1, ≤2, ≤3, ≤4, ≤5, ≤10 and >10 minutes post-treatment. | During Index Procedure | 
| Freedom From Recanalization | Freedom from clinically relevant recanalization of the target embolization site(s) through 30-days, 6 and 12-months follow-up as confirmed by the Investigator. Clinically relevant recanalization is defined as recanalization through the study device that requires a re-intervention. | 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure | 
| Freedom From Acute Migration | Freedom from clinically relevant acute migration of the study device(s) as confirmed by the Investigator via angiographic assessment during the Index Procedure. Clinically relevant migration is defined as migration of the study device from the target embolization site that requires intervention. | During Index Procedure | 
| Freedom From Non-Acute Migration | Freedom from clinically relevant migration of the study device(s) through 30 day, 6 month and 12 month follow-up was reported by the Investigators. Clinically relevant migration is defined as migration of the study device from the target embolization site that requires intervention. | 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 | Freedom from device and/or procedure-related adverse events (AE) through 30-days, 6 and 12-months follow-up. | 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure | 
| Accuracy of Delivery | Accurate delivery of the study device to the target embolization site as assessed by the Investigator. | During Index Procedure | 
| Ease of Trackability/Deliverability | Ease of study device trackability and deliverability as assessed by the Investigator. | During Index Procedure | 
| Ease of Detachment | Ease of study device detachment as assessed by the Investigator. | During Index Procedure | 
| Acceptability of Visibility Under Fluoroscopy | Acceptability of study device visibility under fluoroscopy as assessed by the Investigator. | During Index Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arterial Embolization, Vascular Plug