Registry of Angiovac Procedures In Detail Outcomes Database-RAPID Registry

Pulmonary Embolism Clinical Trial

— RAPID  

Official title:

Registry of Angiovac Procedures In Detail Outcomes Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414332
• Other study ID #: 2015-SEP-1 Amendment 5
• Status: Completed
• Start date: September 1, 2015
• Est. completion date: February 27, 2020

Study information

• Verified date: May 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: February 27, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• Angiovac device not deployed

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Embolism
• Pulmonary Embolism
• Right Heart Pathology
• Thromboembolism
• Thrombosis
• Venous Thromboembolic Disease
• Venous Thrombosis

Intervention

Other:
• Data collection only
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post procedure outcomes	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.	Procedure and up to 24 hours post procedure