An observational study in Coronary Artery Disease, sponsored by Corindus Inc.. Terminated at 1 site in Poland. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-12-20.
Sponsored by Corindus Inc. (part of Siemens Healthineers) · Observational
Among 154 studies in Coronary Artery Disease with a site in Poland — 34 open to participants now, 47 under way, 4 of them phase 3. Coronary Artery Disease · Poland.
Among the 154 studies in Coronary Artery Disease with a site in Poland, this one is the 38th largest by enrollment of the 40 observational ones that give a count, is one of 6 that started in 2021, is one of 40 observational ones, and was the 113th registered.
4,861 studies on the registry are indexed under Coronary Artery Disease; 892 are open to participants now.
Browse Coronary Artery Disease studies →34 of the 154 studies in Coronary Artery Disease with a site in Poland are open now. Recruiting first, the newest first:
Teleflex · Sites in Poland, United States, France and 1 more country
Ages 18–80
Shunmei Medical · Sites in Poland, France, Germany and 1 more country
Ages 18+
Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o. · Sites in Poland
Ages 18+
Collegium Medicum w Bydgoszczy · Sites in Poland
Ages 18+
Medical University of Bialystok · Sites in Poland
Ages 18–75
A study can be open while its sites in Poland have not opened yet or have stopped. Only those recruiting at a site in Poland →
Of the 588 Coronary Artery Disease studies recruiting now, 403 (69%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 20 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
154 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 9 · Phase 3 25 · Phase 4 18
First in 1999; this study’s year is marked. 6 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 50 is below the median of 323 across 1,688 observational studies indexed under Coronary Artery Disease.
Median enrollment 348 across the 114 interventional studies, 585 across the 40 observational. Of the 91 that completed or were terminated, 23 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
75 of 154 have an industry lead sponsor. The 10 most frequent:
This study is registered under Corindus Inc., one of the names counted as Siemens Healthineers. Under that name alone:
Corindus Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Siemens Healthineers has 8 studies filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
9 of the studies in Coronary Artery Disease with a site in Poland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03781492Silesian Centre for Heart DiseasesStable Angina Management and Treatment | 2026-12-31 |
| NCT04545112XeltisXeltis Coronary Artery Bypass Graft (XABG) First in Human (FIH) | 2027-02 |
| NCT07078370Vascudyne, Inc.Safety Study of Acellular Tissue Engineered Vessel for Coronary Artery Bypass | 2027-03-30 |
| NCT06451146Regional Cardiology Center, The Copper Health Centre (MCZ),Lower Silesian Orbital Atherectomy Registry (LOAR) | 2027-05-01 |
| NCT07091682Biotronik AGSafety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions | 2027-06 |
Add all 9 to your calendar (.ics) → With an account.
Among the 154 studies in Coronary Artery Disease with a site in Poland, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The objective of the present study is to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice.
This multi-center, international, randomized, open-label, post-market study will enroll subjects to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice by randomized comparison with a cohort of subjects undergoing robotic-assisted PCI with technIQ automated movements disabled. A secondary objective is to describe the learning curve associated with using technIQ.
The targeted population is subjects with coronary artery disease and with a clinical indication for PCI.
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.
CorPath GRX with technIQ automated movements enabled (technIQ ON)
Device: CorPath GRX with technIQ automated movements enabled (technIQ ON)
CorPath GRX with technIQ automated movements disabled (technIQ OFF).
Device: CorPath GRX with technIQ automated movements disabled (technIQ OFF).
The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures. TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be enabled and used at the discretion of the interventionalist.
The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures. TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be disabled.
Major Clinical and Angiographic Complications (MCAC)
The rate of the combined MCAC endpoint (a composite of MACE and Major Clinical and Angiographic Complications) in the technIQ ON group is not significantly higher than in the technIQ OFF group.
Time frame: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
Technical Success
Residual stenosis of \<30% in all target lesions with final TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 by angiographic core lab analysis, AND absence of unplanned manual conversion.
Time frame: During the Procedure
PCI procedure time
Time between insertion of guide catheter and final removal of guide catheter.
Time frame: During the Procedure
Procedure success
The rate of procedure success in the technIQ ON group is not significantly lower than that in the technIQ OFF group.
Time frame: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
Major adverse cardiovascular events (MACE),
Reported as a composite and components of Cardiac Death, Target Vessel MI, and Target Vessel Revascularization (TVR).
Time frame: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
Major angiographic complications
Reported as perforation(Type 1, 2, 3) or flow-limiting dissection (Type E, F).
Time frame: During the Procedure
Serious Adverse Events (SAE)
All Serious Adverse Events (SAEs) from the start of the CorPath GRX PCI procedure through 72 hours postprocedure or hospital discharge (whichever occurs) first will be summarized
Time frame: Procedure through 72 hours postprocedure or hospital discharge (whichever occurs)
Guidewire Wiring Time
The time required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion.
Time frame: During the Procedure
Fluoroscopy Time to Cross Lesion
The fluoroscopy time required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion.
Time frame: During the Procedure
Contrast Used to Cross Lesion
The amount of contrast (in ml) required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion.
Time frame: During the Procedure
Total Procedural Time
The time from the start of the sheath insertion to complete removal of the final guide catheter.
Time frame: During the Procedure
Total Fluoroscopy Time
The total fluoroscopy time during the procedure as recorded by an Imaging System.
Time frame: During the Procedure
Subject Radiation Exposure
Dose-area-product (DAP) as recorded during the procedure
Time frame: During the Procedure
Subject Radiation Dose
air kerma (AK) as recorded during the procedure.
Time frame: During the Procedure
Contrast Fluid Volume
The total contrast volume used during the procedure.
Time frame: During the Procedure
Planned Manual Conversion (PMC)
Planned manual conversion (PMC) is disengagement of the robotic drive to use bedside manipulation of either the guide catheter, guidewire, or delivery system that was prespecified in the procedural plan (e.g., to accommodate adjunctive devices or procedural techniques that are not compatible with the robotic platform, such as intravascular ultrasound or atherectomy devices). This will be assessed by a questionnaire.
Time frame: During the Procedure
Unplanned Manual Conversion (UMC)
Unplanned manual conversion (UMC) is disengagement of the robotic drive to use bedside manipulation of either the guide catheter, guidewire, or delivery system that was not prespecified in the procedural plan, and that was due to inability to navigate to the target lesion as intended, cross the target lesion as intended, treat the target lesion as intended, retract the CorPath GRX system as intended, or other CorPath system device malfunction; or any clinical condition that requires rapid medical intervention. This will be assessed by a questionnaire.
Time frame: During the Procedure
Partial Manual Assistance (PMA)
Partial manual assistance (PMA) is the use of manual techniques that were not prespecified in the procedural plan and do not meet the definition of unplanned manual conversion (e.g., unplanned use of manual techniques to accommodate adjunctive devices or procedural techniques that are not compatible with the robotic platform). These will be assessed by a questionnaire.
Time frame: During the Procedure
Device Malfunction
The device malfunction will report the inadequacy of the medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance. Investigators are instructed to report all device deficiencies and device malfunctions using the device malfunction form in the EDC.
Time frame: During the Procedure
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2021 to primary completion in Feb 2022, 7 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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