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

NCT04396041 | Completed FDA Device

• 1 other identifier: IRB00173822
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pulmonary Arteriovenous Malformation; PAVM; HHT; hereditary hemorrhagic telangiectasia

Outcome Measures

Primary Outcomes (2)

• Reperfusion Rates

  Analyzed at 1 year and 3 years. Based on the investigators' preliminary data, reperfusion has been seen at 1-2 years in the patients the investigators have treated with coils and AVP making the 3-year goal for the investigators' prospective analysis feasible to cover reperfusion.

  Up to 3 Years

• Immediate post-procedural success

  Immediate post-procedural technical success defined as complete occlusion of the feeding artery supplying the PAVM.

  Immediately after procedure up to 5 minutes

Secondary Outcomes (7)

• Procedure duration

  Up to 4 hours

• Fluoroscopy time

  Up to 4 hours

• Contrast dose

  Up to 4 hours

• Cost of embolic device per PAVM

  Up to 4 hours

• Overall procedure cost for PAVM

  Up to 1 week

Study Arms (1)

Patients treated for Pulmonary Arteriovenous Malformation

All participants in the study will be patients who have been treated for Pulmonary Arteriovenous Malformation using Microvascular Plugs, Amplatzer Vascular Plugs or Detachable coils.

Device: Microvascular Plug (MVP); Device: Amplatzer Vascular Plug (AVP); Device: Detachable coils

Interventions

Microvascular Plug (MVP) DEVICE

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

Patients treated for Pulmonary Arteriovenous Malformation

Amplatzer Vascular Plug (AVP) DEVICE

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

Patients treated for Pulmonary Arteriovenous Malformation

Detachable coils DEVICE

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

Patients treated for Pulmonary Arteriovenous Malformation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Pulmonary Arteriovenous Malformation (PAVM) being treated through the Interventional Radiology clinic.

You may qualify if:

• Undergoing embolization of Pulmonary Arteriovenous Malformation (PAVM)

You may not qualify if:

• PAVM unable to be embolized

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Pulmonary Arteriovenous Fistulas; Telangiectasia, Hereditary Hemorrhagic

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Clifford R Weiss, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 20, 2020
• Study Start: September 1, 2018
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

US (1)