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 Withdrawn.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. (part of Siemens Healthineers) · 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.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
Browse Peripheral Arterial Disease studies →Corindus Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
First submitted after Corindus Inc. became part of Siemens Healthineers.
Counted across the registry records on this site, refreshed daily.
Subjects with a clinical indication for Peripheral Vascular Intervention (PVI).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Plan to share: No
Start is estimated for Jan 2022; primary completion for Jan 2023, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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