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. · Observational
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).
Exclusion Criteria:
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 |
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Corindus Inc.