An observational study in Peripheral Arterial Disease, Peripheral Vascular Diseases and Renal Artery Disease, sponsored by Corindus Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-23.
Sponsored by Corindus Inc. · Observational
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.
Subjects with a clinical indication for Peripheral Vascular Intervention (PVI).
Exclusion Criteria:
Subjects with a clinical indication for Peripheral Vascular Intervention (PVI).
Device: Procedure/Surgery: Robotic-PVI
Robotic-assisted (CorPath GRX System) percutaneous vascular interventions.
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.
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
Operator Radiation Exposure
Cumulative dose the operator receives as recorded from an electronic pocket dosimeter during the procedure.
Time frame: Procedure
Staff Radiation Exposure
Cumulative dose the staff receives as recorded from an electronic pocket dosimeter during the procedure.
Time frame: Procedure
Patient Radiation Exposure
DAP (dose-area-product) and AK (air kerma) as recorded during the procedure.
Time frame: Procedure
Contrast Fluid Volume
Total volume of contrast (mL) used during the procedure.
Time frame: Procedure
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Corindus Inc.