ACHIEVE GRX Registry

Corindus Inc.

Overview

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

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

Conditions

Peripheral Arterial Disease Peripheral Vascular Diseases Renal Artery Disease Carotid Artery Diseases

Interventions

Procedure/Surgery: Robotic-PVIDEVICE

Robotic-assisted (CorPath GRX System) percutaneous vascular interventions.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Technical Success

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.

Time frame: Procedure

Clinical Success

\<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).

Time frame: Within 24 hours of the procedure or hospital discharge, whichever occurs first.

Safety

A composite of intra- and peri-procedural events, including target vessel rupture, clinically significant perforation or dissection, and distal embolization.

Time frame: Within 24 hours of the procedure or hospital discharge, whichever occurs first.

Secondary Outcomes

PVI Procedure Time

Defined as the time measured from the insertion of the guiding sheath until the removal of the guiding sheath.

Time frame: Procedure

Manual Time

Defined as the total amount of time the procedure is completed using a manual technique.

Time frame: Procedure

Robotic Time

Defined as the total amount of time the procedure is completed robotically from the robotic cock-pit.

Time frame: Procedure

Fluoroscopy Time

Total fluoroscopy utilized during the procedure as recorded by an Imaging System.

Time frame: Procedure

Data from ClinicalTrials.gov

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