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NCT04396041 · ClinicalTrials.gov registry record
Microvascular Plug (MVP) for the Treatment of Pulmonary ArterioVenous Malformations (PAVMs)
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 223
- Enrollment target
NCT04396041: Completed study, sponsored by Johns Hopkins University.
NCT04396041 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 223 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04396041 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 223 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- DEVICE Microvascular Plug (MVP)
- DEVICE Amplatzer Vascular Plug (AVP)
- DEVICE Detachable coils
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2023-01-31 |
What the finished NCT04396041 record still lists
NCT04396041 is an observational study that tracks outcomes without assigning an intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Microvascular Plug (MVP) is the first listed.
NCT04396041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04396041 about?
NCT04396041 is a clinical study titled "Microvascular Plug (MVP) for the Treatment of Pulmonary ArterioVenous Malformations (PAVMs)". 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 hea...
What is the current status of trial NCT04396041?
This trial is currently completed. The enrollment target is 223 participants. The study started on 2018-09-01. Estimated completion is 2023-01-31.
What interventions are being tested in trial NCT04396041?
The interventions under investigation include: Microvascular Plug (MVP) (DEVICE), Amplatzer Vascular Plug (AVP) (DEVICE), Detachable coils (DEVICE).
Who is sponsoring clinical trial NCT04396041?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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