An observational study in Coronary Artery Disease, Coronary Disease and Myocardial Ischemia, sponsored by Corindus Inc.. Completed at 16 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-22.
Sponsored by Corindus Inc. (part of Siemens Healthineers) · Observational
Among 1,105 studies in Coronary Artery Disease with a site in United States — 101 open to participants now, 146 under way, 10 of them phase 3. Coronary Artery Disease · United States.
Among the 1,105 studies in Coronary Artery Disease with a site in United States, this one is the 91st largest by enrollment of the 357 observational ones that give a count, is one of 60 that started in 2013, is one of 358 observational ones, and was the 588th registered.
4,861 studies on the registry are indexed under Coronary Artery Disease; 892 are open to participants now.
Browse Coronary Artery Disease studies →101 of the 1,105 studies in Coronary Artery Disease with a site in United States are open now. Recruiting first, the newest first:
EBI Anti Sepsis BV · Sites in United States, Belgium, Netherlands and 1 more country
Ages 18+
University of Colorado, Denver · Sites in United States
Ages 55+
Verve Therapeutics, Inc. · Sites in United States
Ages 18–70
Novartis Pharmaceuticals · Sites in United States, Australia, Germany and 2 more countries
Ages 18–80
Minneapolis Heart Institute Foundation · Sites in United States
Ages 22+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
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: 18 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.
1,105 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 50 · Phase 2 104 · Phase 3 112 · Phase 4 141
First in 1985; this study’s year is marked. 60 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 754 is above the median of 323 across 1,688 observational studies indexed under Coronary Artery Disease.
Median enrollment 107 across the 746 interventional studies, 186 across the 357 observational. Of the 839 that completed or were terminated, 355 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
378 of 1,105 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.
51 of the studies in Coronary Artery Disease with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07357675Phase 3EBI Anti Sepsis BVA Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery. | 2027-10-01 |
| NCT06305559Phase 3NewAmsterdam PharmaA CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque | 2027-11 |
| NCT01114269Brigham and Women's HospitalPRE-DETERMINE Cohort Study | 2026-11 |
| NCT06713239Cleerly, Inc.A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CAD | 2026-12 |
| NCT03894423Stanford UniversityComprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery | 2026-12 |
Add all 51 to your calendar (.ics) → With an account.
Among the 1,105 studies in Coronary Artery Disease with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath 200 System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters during PCI procedures.
This is a prospective, single-arm, open-label, multi-center patient registry of the CorPath 200 System to examine its performance during PCI procedure and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.
Subjects with coronary artery disease and with the clinical indication for Percutaneous Coronary Intervention (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.
Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)
Procedure: CorPath-assisted Percutaneous Coronary Intervention
Robotic-assisted Percutaneous Coronary Intervention
Also known as: Robotic-assisted Percutaneous Coronary Intervention
Number of Participants With Clinical Success
Less than 30% residual stenosis post PCI in the lesion(s) treated with the CorPath system, without in-hospital major adverse coronary events (MACE).
Time frame: In-hospital (72-hours or discharge, whichever occurs first)
Number of Participants With In-hospital Major Adverse Coronary Events (MACE)
The composite of death, myocardial infarction, and target vessel revascularization that occurs within 72 hours of the procedure or prior to hospital discharge, whichever occurs first, in a subject treated with the CorPath 200 System.
Time frame: In-hospital (72-hours or discharge, whichever occurs first)
Number of Participants With an Adverse Event
All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) from the start of the CorPath procedure until the end of the study will be summarized.
Time frame: In-hospital (72-hours or discharge, whichever occurs first)
Overall Procedure Time
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Time frame: During procedure
PCI Procedure Time
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Time frame: During procedure
Fluoroscopy and/or X-Ray Time
As recorded by an X-Ray System utilized during the procedure.
Time frame: During procedure
Contrast Fluid Volume
The amount of contrast fluid used (mL) during the procedure.
Time frame: During procedure
Patient Radiation Exposure - Dose-Area-Product
DAP (dose-area-product) as recorded during the procedure.
Time frame: During procedure
Patient Radiation Exposure - Cumulative Dose
Cumulative dose (mGy) as recored during the procedure.
Time frame: During procedure
Number of Participants Who Had a Conversions to Manual Technique.
The overall number of conversions from the robotic PCI to manual PCI will be captured to analyze the technical success of the device.
Time frame: During procedure
Visual Measurement of Lesion Length
Visual estimate by clinical operator prior to delivery of PCI device(s).
Time frame: During procedure
CorPath Measurement of Lesion Length
Robotic measurement of lesion length using the CorPath System performed by the Clinical Operator.
Time frame: During procedure
Patients that had a robotic-assisted PCI procedure.
| Milestone | Study Cohort |
|---|---|
| Started | 754 |
| Completed | 754 |
| Not completed | 0 |
Less than 30% residual stenosis post PCI in the lesion(s) treated with the CorPath system, without in-hospital major adverse coronary events (MACE).
| Participants | Study Cohort |
|---|---|
| Number of Participants With Clinical Success | 723 |
The composite of death, myocardial infarction, and target vessel revascularization that occurs within 72 hours of the procedure or prior to hospital discharge, whichever occurs first, in a subject treated with the CorPath 200 System.
| Participants | Study Cohort |
|---|---|
| Number of Participants With In-hospital Major Adverse Coronary Events (MACE) | 6 |
All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) from the start of the CorPath procedure until the end of the study will be summarized.
| Participants | Study Cohort |
|---|---|
| Number of Participants With an Adverse Event | 18 |
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
| min | Study Cohort |
|---|---|
| Overall Procedure Time | 61.9 ± 28.3 |
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
| min | Study Cohort |
|---|---|
| PCI Procedure Time | 43.6 ± 23.1 |
As recorded by an X-Ray System utilized during the procedure.
| min | Study Cohort |
|---|---|
| Fluoroscopy and/or X-Ray Time | 15.0 ± 8.4 |
The amount of contrast fluid used (mL) during the procedure.
| mL | Study Cohort |
|---|---|
| Contrast Fluid Volume | 181.1 ± 90.8 |
DAP (dose-area-product) as recorded during the procedure.
| mGy*cm2 | Study Cohort |
|---|---|
| Patient Radiation Exposure - Dose-Area-Product | 120861.3 ± 256522.9 |
Cumulative dose (mGy) as recored during the procedure.
| mGy | Study Cohort |
|---|---|
| Patient Radiation Exposure - Cumulative Dose | 1631.5 ± 3664.5 |
The overall number of conversions from the robotic PCI to manual PCI will be captured to analyze the technical success of the device.
| Participants | Study Cohort |
|---|---|
| Number of Participants Who Had a Conversions to Manual Technique. | 99 |
Visual estimate by clinical operator prior to delivery of PCI device(s).
| mm | Visual Estimate |
|---|---|
| Visual Measurement of Lesion Length | 17.3 ± 9.8 |
Robotic measurement of lesion length using the CorPath System performed by the Clinical Operator.
| mm | Study Cohort |
|---|---|
| CorPath Measurement of Lesion Length | 19.1 ± 10.6 |
Collected over Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Cohort | 0/754 (0%) | 18/754 (2.4%) | 0/754 (0%) |
| Event | Study Cohort |
|---|---|
| PERI-PROCEDURAL MI; NSTEMI/NON QWAVE MICardiac disorders | 4/754 |
| TRANSIENT BRADYCARDIA/HYPOTENSIONCardiac disorders | 1/754 |
| FLUID RETENSIONCardiac disorders | 1/754 |
| RECURRENT CHEST, RIGHT SHOULDER, RIGHT ARM PAINCardiac disorders | 1/754 |
| ACUTE NAUSEA AND VOMITINGGastrointestinal disorders | 1/754 |
| URINARY TRACT INFECTIONRenal and urinary disorders | 1/754 |
| DISSECTION DURING MANUAL PCI LESION #2Cardiac disorders | 1/754 |
| LEFT MAIN DISSECTIONCardiac disorders | 1/754 |
| RESPIRATORY DISTRESSRespiratory, thoracic and mediastinal disorders | 1/754 |
| ABRUPT VESSEL CLOSURE, DUE TO ANGIOPLASTY DISSECTIONCardiac disorders | 1/754 |
| Age, Continuous(years) | Study Cohort |
|---|---|
| Mean | 66.9 ± 12.1 |
| Sex: Female, Male(Participants) | Study Cohort |
|---|---|
| Female | 200 |
| Male | 554 |
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2013 to primary completion in Dec 2016, 40 months.
Results were first posted in Dec 2020, 4 years after primary completion.
Of 125 industry-sponsored observational studies under Coronary Artery Disease, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's 40 months is above that.
Counting every sponsor, half of 760 studies reached it within 41 months; a quarter within 21 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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