Registry of Angiovac Procedures In Detail Outcomes Database-RAPID Registry (RAPID)

May 29, 2020 updated by: John Moriarty, MD, University of California, Los Angeles

Registry of Angiovac Procedures In Detail Outcomes Database

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients ages 18 years and older in whom the Angiovac device was deployed.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post procedure outcomes
Time Frame: 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.
Procedure and up to 24 hours post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: John Moriarty, MD, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

February 27, 2020

Study Completion (ACTUAL)

February 27, 2020

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (ACTUAL)

June 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2020

Last Update Submitted That Met QC Criteria

May 29, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-SEP-1 Amendment 5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Share de-identified information regarding procedure specifics as per case report forms and procedure outcomes

IPD Sharing Time Frame

as per individual contract

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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