ACHIEVE GRX Registry

Sponsor

Corindus Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04513613

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease Peripheral Vascular Diseases Renal Artery Disease Carotid Artery Diseases	Device: Procedure/Surgery: Robotic-PVI

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 Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Technical Success [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.
Clinical Success [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).
Safety [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Corindus Inc.

Investigators

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

Study Documents (Full-Text)

Study Protocol - Jul 28, 2020

More Information

Publications

Responsible Party:

Corindus Inc.

ClinicalTrials.gov Identifier:

NCT04513613

Other Study ID Numbers:

104-09200

First Posted:

Aug 14, 2020

Last Update Posted:

Apr 23, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Carotid Artery Diseases

Peripheral Arterial Disease

Peripheral Vascular Diseases

Vascular Diseases

Study Results

No Results Posted as of Apr 23, 2021