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Microvascular Plug (MVP) for the Treatment of Pulmonary ArterioVenous Malformations (PAVMs)

NCT04396041 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 223

Last updated 2023-02-01

No results posted yet for this study

Summary

The purpose of this study is to compare the use of the Micro Vascular Plug (MVP) system and other embolic devices in treatment of PAVMs. Pulmonary Arteriovenous Malformations (PAVMs) are abnormal connections between the pulmonary vein and the pulmonary artery. This affects blood flow between the heart and lungs which puts patients at risk of stroke, brain abscess, hypoxia and even sudden death. The standard treatment of PAVMs is embolization. Embolization is the placing of an embolic (synthetic agent) into a blood vessel to block blood flow. The embolic is inserted via a catheter into the blood vessel. Detachable coils are the most commonly used embolic in the treatment of PAVMs. Despite long procedure times, numerous coils that are often required to occlude a single PAVM and recanalization rates ranging from 5% to 15%, the most widely used embolic device is still the detachable coil.

Conditions

  • Pulmonary Arteriovenous Malformation

Interventions

DEVICE

Microvascular Plug (MVP)

Patient's Pulmonary AVM(s) treated via transcatheter embolization with Microvascular Plugs.

DEVICE

Amplatzer Vascular Plug (AVP)

Patient's Pulmonary AVM(s) treated via transcatheter embolization with Amplatzer Vascular Plugs.

DEVICE

Detachable coils

Patient's Pulmonary AVM(s) treated via transcatheter embolization with detachable coils.

Sponsors & Collaborators

Principal Investigators

  • Clifford R Weiss, M.D. · Johns Hopkins University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2023-01-31
Completion
2023-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04396041 on ClinicalTrials.gov