Caterpillar™ Arterial Embolization Device Post-Market Study (MONARCH)

• ClinicalTrials.gov Identifier: NCT04244370
• Recruitment Status: Active, not recruiting
• First Posted: January 28, 2020
• Last Update Posted: January 11, 2022
• Sponsor: C. R. Bard
• Information provided by (Responsible Party): C. R. Bard

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Embolization, Therapeutic	Device: Caterpillar™ Arterial Embolization Device	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: April 30, 2020
• Actual Primary Completion Date: August 13, 2021
• Estimated Study Completion Date: July 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Caterpillar™ Arterial Embolization Device; Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).	Device: Caterpillar™ Arterial Embolization Device; Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.; Other Names: Caterpillar™ Micro (027); Caterpillar™ (038 & 056)

Outcome Measures

Primary Outcome Measures :

1. Technical Success [ Time Frame: 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.
2. Freedom from Device-Related SAEs [ Time Frame: 30 (-7/+21) Days ]
   Freedom from device-related serious adverse events (SAE) through 30-day follow-up.

Secondary Outcome Measures :

1. Time Point of Occlusion [ Time Frame: Index Procedure ]
   The percentage of target embolization site(s) with occlusion at ≤1, ≤2, ≤3, ≤4, ≤5, ≤10 and >10 minutes post-treatment.
2. Freedom from Recanalization [ Time Frame: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) ]
   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. Freedom from recanalization will be reported for each target embolization site.
3. Freedom from Migration [ Time Frame: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) ]

   Freedom from Migration will be reported for each study device as follows:

   • 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.
   • Freedom from clinically relevant migration of the study device(s) through 30-days, 6 and 12-months follow-up as confirmed by the Investigator. Clinically relevant migration is defined as migration of the study device from the target embolization site that requires a re-intervention.
4. Freedom from Device and/or Procedure-Related Adverse Events [ Time Frame: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) ]
   Freedom from device and/or procedure-related adverse events (AE) through 30-days, 6 and 12-months follow-up.
5. Accuracy of Delivery [ Time Frame: Index Procedure ]
   Accurate delivery of the study device to the target embolization site as assessed by the Investigator.
6. Ease of Trackability/Deliverability [ Time Frame: Index Procedure ]
   Ease of study device trackability and deliverability as assessed by the Investigator.
7. Ease of Detachment [ Time Frame: Index Procedure ]
   Ease of study device detachment as assessed by the Investigator.
8. Acceptability of Visibility [ Time Frame: Index Procedure ]
   Acceptability of study device visibility under fluoroscopy as assessed by the Investigator.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Arizona

Dignity Health/St. Joseph's & Medical Center

Phoenix, Arizona, United States, 85013

United States, Florida

Baptist Hospital of Miami

Miami, Florida, United States, 33176

United States, Indiana

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

United States, Kansas

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States, 66160

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

United States, Minnesota

University of Minnesota Medical Center - Fairview

Minneapolis, Minnesota, United States, 55455

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

United States, Pennsylvania

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

United States, Texas

Cardiothoracic and Vascular Surgeons

Austin, Texas, United States, 78756

University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

United States, Wisconsin

The Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

C. R. Bard

Investigators

• Principal Investigator: William Rilling, MD, FSIR; Medical College of Wisconsin

More Information

• Responsible Party: C. R. Bard
• ClinicalTrials.gov Identifier: NCT04244370
• Other Study ID Numbers: BPV-18-001
• First Posted: January 28, 2020
• Last Update Posted: January 11, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by C. R. Bard:

Arterial Embolization; Vascular Plug