ACHIEVE GRX Registry

April 21, 2021 updated by: Corindus Inc.

A Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Peripheral Vascular Interventions

This study will evaluate real-world performance of the CorPath GRX System in peripheral vascular interventions.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-arm, open-label, multi-center registry of the CorPath GRX System to evaluate its real-world performance during peripheral vascular interventions.

Study Type

Observational

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

Subjects with a clinical indication for Peripheral Vascular Intervention (PVI).

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Subject has a clinical indication for Peripheral Vascular Intervention (PVI).
  3. Subject is deemed appropriate for robotic-assisted PVI.
  4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
  5. Individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure.

Exclusion Criteria:

  1. Failure/inability/unwillingness to provide informed consent.
  2. The investigator determines the subject or the peripheral anatomy is not suitable for ro-botic-assisted PVI.
  3. Women who are pregnant.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with a clinical indication for PVI
Subjects with a clinical indication for Peripheral Vascular Intervention (PVI).
Device: Procedure/Surgery: Robotic-PVI
Robotic-assisted (CorPath GRX System) percutaneous vascular interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: Procedure
Successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy.
Procedure
Clinical Success
Time Frame: Within 24 hours of the procedure or hospital discharge, whichever occurs first.
<30% residual stenosis in all CorPath System treated lesions at the completion of the interventional procedure in the absence of device-related serious adverse event (SAE).
Within 24 hours of the procedure or hospital discharge, whichever occurs first.
Safety
Time Frame: Within 24 hours of the procedure or hospital discharge, whichever occurs first.
A composite of intra- and peri-procedural events, including target vessel rupture, clinically significant perforation or dissection, and distal embolization.
Within 24 hours of the procedure or hospital discharge, whichever occurs first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PVI Procedure Time
Time Frame: Procedure
Defined as the time measured from the insertion of the guiding sheath until the removal of the guiding sheath.
Procedure
Manual Time
Time Frame: Procedure
Defined as the total amount of time the procedure is completed using a manual technique.
Procedure
Robotic Time
Time Frame: Procedure
Defined as the total amount of time the procedure is completed robotically from the robotic cock-pit.
Procedure
Fluoroscopy Time
Time Frame: Procedure
Total fluoroscopy utilized during the procedure as recorded by an Imaging System.
Procedure
Operator Radiation Exposure
Time Frame: Procedure
Cumulative dose the operator receives as recorded from an electronic pocket dosimeter during the procedure.
Procedure
Staff Radiation Exposure
Time Frame: Procedure
Cumulative dose the staff receives as recorded from an electronic pocket dosimeter during the procedure.
Procedure
Patient Radiation Exposure
Time Frame: Procedure
DAP (dose-area-product) and AK (air kerma) as recorded during the procedure.
Procedure
Contrast Fluid Volume
Time Frame: Procedure
Total volume of contrast (mL) used during the procedure.
Procedure

Collaborators and Investigators

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

Sponsor

Corindus Inc.

Investigators

  • Principal Investigator: Jon George, MD, Einstein Medical Center
  • Principal Investigator: John Phillips, MD, Riverside Methodist Hospital

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 (ANTICIPATED)

January 1, 2022

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (ACTUAL)

August 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104-09200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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