Registry of Angiovac Procedures In Detail Outcomes Database-RAPID Registry

Completed

• Conditions: Venous Thromboembolic Disease; Deep Venous Thrombosis; Pulmonary Embolism; Right Heart Pathology

• Registration Number: NCT04414332
• Lead Sponsor: University of California, Los Angeles

Brief Summary

Venous thromboembolic disease is a significant cause of morbidity and mortality. The purpose of the RAPID registry is to collect information on the Angiovac procedure and Angiovac device used in the treatment of deep venous thrombosis (DVT), right heart pathology and pulmonary embolism.

Detailed Description

Venous thromboembolic disease is a significant cause of morbidity and mortality. Thrombolytic therapy has been shown to be a successful treatment modality, however its use is somewhat limited due to the known risk of hemorrhage (overall 22%, with up to 3% intracranial hemorrhage), and suggested risk of distal embolization where large mobile thrombi are encountered. In patients where either thrombolysis is contraindicated or unsuccessful and conventional therapies inadequate, bulk thrombectomy may be considered. Until recently this was primarily achieved with surgical thrombectomy; however the Angiovac device is posited to offer a minimally invasive alternative.

This registry will collect data on patients in whom the Angiovac device was placed into the body for management of inferior vena cava (IVC) clots, right atrial (RA) masses or pulmonary emboli (PE) will be included.

This registry is to capture high quality patient safety and effectiveness data on use of the Angiovac device for 3 separate, but overlapping conditions; a) Iliofemoral and Caval DVT, b) Right heart masses, and c) PE. The goal will be achieved by capturing a concise set of immediate and short-term functional and clinical outcome data for all patients who have the angiovac catheter deployed into the vascular system.

Any center performing Angiovac procedure and wishing to contribute patient data will be offered participation in the registry. These core sites will be required to submit the registry protocol for Institutional Review Board (IRB) review. Once documentation of IRB approval has been received, centers may transmit their data via secure REDCap (Research Electronic Data Capture) database in accordance with federal regulations in the Health Insurance Portability and Accountability Act (HIPAA

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2020-02-27
• Study Completion: 2020-02-27
• Status Verified: 2020-05
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-05-29
• Last Update Submitted: 2020-05-29
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

• All patients in whom the Angiovac device was placed into the body for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

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Exclusion Criteria

• Angiovac device not deployed

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post procedure outcomes	Procedure and up to 24 hours post procedure	to collect information on the Angiovac procedure and Angiovac device used in the treatment of deep venous thrombosis (DVT), right heart pathology and pulmonary embolism.