NCT04244370

Caterpillar™ Arterial Embolization Device Post-Market Study

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Embolization, Therapeutic

Interventions

Type	Name	Description
DEVICE	Caterpillar™ Arterial Embolization Device	Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.

Timeline

• Start date: 2020-04-30
• Primary completion: 2021-08-13
• Completion: 2022-08-12
• First posted: 2020-01-28
• Last updated: 2023-07-25
• Results posted: 2022-10-12

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study