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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Cohort | Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CorPath-assisted Percutaneous Coronary Intervention | Procedure | Robotic-assisted Percutaneous Coronary Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | In-hospital (72-hours or discharge, whichever occurs first) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | In-hospital (72-hours or discharge, whichever occurs first) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Procedure Time | Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. | During procedure |
| PCI Procedure Time | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. |
Inclusion Criteria:
Exclusion Criteria:
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Subjects with coronary artery disease and with the clinical indication for Percutaneous Coronary Intervention (PCI).
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| Name | Affiliation | Role |
|---|---|---|
| Giora Weisz, MD | Columbia University Medical Center/New York-Presbyterian Hospital | Principal Investigator |
| Chris Cain | VP, Clinical Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Medical Center | San Diego | California | 92103 | United States | ||
| Valley View Hospital |
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Patients that had a robotic-assisted PCI procedure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Cohort | Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | In-hospital (72-hours or discharge, whichever occurs first) |
| During procedure |
| Fluoroscopy and/or X-Ray Time | As recorded by an X-Ray System utilized during the procedure. | During procedure |
| Contrast Fluid Volume | The amount of contrast fluid used (mL) during the procedure. | During procedure |
| Patient Radiation Exposure - Dose-Area-Product | DAP (dose-area-product) as recorded during the procedure. | During procedure |
| Patient Radiation Exposure - Cumulative Dose | Cumulative dose (mGy) as recored during the procedure. | 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. | During procedure |
| Visual Measurement of Lesion Length | Visual estimate by clinical operator prior to delivery of PCI device(s). | During procedure |
| CorPath Measurement of Lesion Length | Robotic measurement of lesion length using the CorPath System performed by the Clinical Operator. | During procedure |
| Glenwood Springs |
| Colorado |
| 81601 |
| United States |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Orlando Regional Medical Center | Orlando | Florida | 32806 | United States |
| North Georgia Heart Foundation | Gainesville | Georgia | 30501 | United States |
| St. Elizabeth's Medical Center | Boston | Massachusetts | 02135 | United States |
| Spectrum Health System | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic | Rochester | Minnesota | 55906 | United States |
| Columbia University Medical Center/New York-Presbyterian Hospital | New York | New York | 10032 | United States |
| St. Joseph's Hospital Health Center | Syracuse | New York | 13203 | United States |
| Carolinas Medical Center - Northeast | Concord | North Carolina | 28203 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Sanford Health | Sioux Falls | South Dakota | 57104 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Virginia Commonwealth Univ. Medical Center | Richmond | Virginia | 23298 | United States |
| Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Cohort | Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Number of participants with complete data to assess clinical success. | Posted | Count of Participants | Participants | In-hospital (72-hours or discharge, whichever occurs first) |
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| Secondary | 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. | Number of participants with complete data to assess In-hospital Major Adverse Coronary Events (MACE). | Posted | Count of Participants | Participants | In-hospital (72-hours or discharge, whichever occurs first) |
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| Secondary | 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. | Number of participants with complete data to assess Adverse Events. | Posted | Count of Participants | Participants | In-hospital (72-hours or discharge, whichever occurs first) |
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| Other Pre-specified | Overall Procedure Time | Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. | Number of participants that had completed data to assess Overall procedure time. | Posted | Mean | Standard Deviation | min | During procedure |
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| Other Pre-specified | PCI Procedure Time | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. | Number of participants that had complete data to assess PCI procedure time. | Posted | Mean | Standard Deviation | min | During procedure |
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| Other Pre-specified | Fluoroscopy and/or X-Ray Time | As recorded by an X-Ray System utilized during the procedure. | Number of participants with complete data to assess fluoroscopy and/or X-Ray time. | Posted | Mean | Standard Deviation | min | During procedure |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Contrast Fluid Volume | The amount of contrast fluid used (mL) during the procedure. | Number of partcipants with completed data to assess contrast fluid volume. | Posted | Mean | Standard Deviation | mL | During procedure |
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| ||||||||||||||||||||||||||
| Other Pre-specified | Patient Radiation Exposure - Dose-Area-Product | DAP (dose-area-product) as recorded during the procedure. | Number of participants that had completed data to assess patient radiation exposure. The overall number of participants analyzed in the DAP and Cumulative groups differ because of incomplete data recorded from the sites. | Posted | Mean | Standard Deviation | mGy*cm2 | During procedure |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Patient Radiation Exposure - Cumulative Dose | Cumulative dose (mGy) as recored during the procedure. | Number of participants that had completed data to assess patient radiation exposure. The overall number of participants analyzed in the DAP and Cumulative groups differ because of incomplete data recorded from the sites. | Posted | Mean | Standard Deviation | mGy | During procedure |
|
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| Other Pre-specified | 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. | Number of conversions from the robotic PCI to manual PCI in participants with complete data. | Posted | Count of Participants | Participants | During procedure |
|
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| Other Pre-specified | Visual Measurement of Lesion Length | Visual estimate by clinical operator prior to delivery of PCI device(s). | Operator visual lesion length estimate. | Posted | Mean | Standard Deviation | mm | During procedure | Lesions | Lesions |
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| ||||||||||||||||||||||||
| Other Pre-specified | CorPath Measurement of Lesion Length | Robotic measurement of lesion length using the CorPath System performed by the Clinical Operator. | Lesion length measured with CorPath System. | Posted | Mean | Standard Deviation | mm | During procedure | lesions | lesions |
|
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Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Cohort | Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention | 0 | 754 | 18 | 754 | 0 | 754 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TRANSIENT BRADYCARDIA/HYPOTENSION | Cardiac disorders | Non-systematic Assessment |
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| FLUID RETENSION | Cardiac disorders | Non-systematic Assessment |
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| RECURRENT CHEST, RIGHT SHOULDER, RIGHT ARM PAIN | Cardiac disorders | Non-systematic Assessment |
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| ACUTE NAUSEA AND VOMITING | Gastrointestinal disorders | Non-systematic Assessment |
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| URINARY TRACT INFECTION | Renal and urinary disorders | Non-systematic Assessment |
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| DISSECTION DURING MANUAL PCI LESION #2 | Cardiac disorders | Non-systematic Assessment |
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| LEFT MAIN DISSECTION | Cardiac disorders | Non-systematic Assessment |
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| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| ABRUPT VESSEL CLOSURE, DUE TO ANGIOPLASTY DISSECTION | Cardiac disorders | Non-systematic Assessment |
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| URINARY RETENTION | Renal and urinary disorders | Non-systematic Assessment |
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| PERI-PROCEDURAL MI; NSTEMI/NON QWAVE MI | Cardiac disorders | Non-systematic Assessment |
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| PEA ARREST | Cardiac disorders | Non-systematic Assessment |
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| ACUTE CEREBROVASCULAR ACCIDENT (CVA) | Nervous system disorders | Non-systematic Assessment |
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| CONTRAST DYE ALLERGIC REACTION; HYPOTENSION | Cardiac disorders | Non-systematic Assessment |
| ||
| HEMATOCHEZIA | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Van Vleet, VP of Clinical and Regulatory Affairs | Corindus, Inc. | (260)615-8892 | john.van_vleet@siemens-healthineers.com |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Title | Denominators | Categories | ||||
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| lesions |
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