ACHIEVE GRX Registry

Withdrawn

• Conditions: Renal Artery Disease; Peripheral Arterial Disease; Peripheral Vascular Diseases; Carotid Artery Diseases

• Registration Number: NCT04513613
• Lead Sponsor: Corindus Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-14
• Status Verified: 2021-03
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23
• Study Start: 2022-01
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
PVI Procedure Time	Procedure	Defined as the time measured from the insertion of the guiding sheath until the removal of the guiding sheath.
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.
Robotic Time	Procedure	Defined as the total amount of time the procedure is completed robotically from the robotic cock-pit.
Manual Time	Procedure	Defined as the total amount of time the procedure is completed using a manual technique.
Fluoroscopy Time	Procedure	Total fluoroscopy utilized during the procedure as recorded by an Imaging System.
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.