Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions (PRECISION)
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| ClinicalTrials.gov Identifier: NCT01917682 |
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Recruitment Status :
Completed
First Posted : August 7, 2013
Last Update Posted : June 12, 2017
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Sponsor:
Corindus Inc.
Information provided by (Responsible Party):
Corindus Inc.
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Brief Summary:
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases | Procedure: CorPath-assisted Percutaneous Coronary Intervention |
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.
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 754 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 3 Days |
| Official Title: | A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness in Percutaneous Coronary Interventions |
| Actual Study Start Date : | August 2013 |
| Actual Primary Completion Date : | December 2016 |
| Actual Study Completion Date : | December 2016 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Study Cohort
Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)
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Procedure: CorPath-assisted Percutaneous Coronary Intervention
Robotic-assisted Percutaneous Coronary Intervention
Other Name: Robotic-assisted Percutaneous Coronary Intervention |
Primary Outcome Measures :
- Clinical Success [ Time Frame: In-hospital (72 hours or discharge, whichever occurs first) ]Less than 30% residual stenosis post PCI in the lesion(s) treated with the CorPath system, without in-hospital major adverse coronary events (MACE).
Secondary Outcome Measures :
- In-hospital Major Adverse Coronary Events (MACE) [ Time Frame: In-hospital (72 hours or discharge, whichever occurs first) ]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.
- Adverse Events [ Time Frame: In-hospital (72 hours or discharge, whichever occurs first) ]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.
Other Outcome Measures:
- Overall Procedure Time [ Time Frame: During procedure ]Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
- PCI Procedure Time [ Time Frame: During procedure ]Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
- Fluoroscopy and/or X-Ray Time [ Time Frame: During procedure ]As recorded by an X-Ray System utilized during the procedure.
- Patient Radiation Exposure [ Time Frame: During procedure ]DAP (dose-area-product) and cumulative dose as recorded during the procedure.
- Contrast Fluid Volume [ Time Frame: During procedure ]No additional description
- Number of Conversions to Manual [ Time Frame: During procedure ]The overall number of conversions from the robotic PCI to manual PCI will be captured to analyze the technical success of the device.
- Measurement of Lesion and Stented Segment Length [ Time Frame: During procedure ]
- Visual estimate by clinical operator prior to delivery of PCI device(s).
- CorPath 200 System measurement of the segment planned for treatment and length of deployed stent.
- Quantitative Coronary Angiography (QCA) of stented segment length
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects with coronary artery disease and with the clinical indication for Percutaneous Coronary Intervention (PCI).
Criteria
Inclusion Criteria:
- Age >18 years.
- Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI) with the CorPath 200 system.
- The subject or the legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria:
- Concurrent enrollment in another device or drug study protocol that specifically excludes concurrent enrollment or that prevents collection of data required in this registry (concurrent participation in another registry is not an automatic exclusion criterion for this study).
- Failure/inability/unwillingness to provide informed consent.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917682
Locations
| United States, California | |
| UC San Diego Medical Center | |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| Valley View Hospital | |
| Glenwood Springs, Colorado, United States, 81601 | |
| United States, District of Columbia | |
| Medstar Washington Hospital Center | |
| Washington, D.C., District of Columbia, United States, 20010 | |
| United States, Florida | |
| Orlando Regional Medical Center | |
| Orlando, Florida, United States, 32806 | |
| United States, Georgia | |
| North Georgia Heart Foundation | |
| Gainesville, Georgia, United States, 30501 | |
| United States, Massachusetts | |
| St. Elizabeth's Medical Center | |
| Boston, Massachusetts, United States, 02135 | |
| United States, Michigan | |
| Spectrum Health System | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55906 | |
| United States, New York | |
| Columbia University Medical Center/New York-Presbyterian Hospital | |
| New York, New York, United States, 10032 | |
| St. Joseph's Hospital Health Center | |
| Syracuse, New York, United States, 13203 | |
| United States, North Carolina | |
| Carolinas Medical Center - Northeast | |
| Concord, North Carolina, United States, 28203 | |
| United States, Ohio | |
| University Hospitals Case Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
| United States, South Dakota | |
| Sanford Health | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Virginia Commonwealth Univ. Medical Center | |
| Richmond, Virginia, United States, 23298 | |
| Israel | |
| Shaare Zedek Medical Center | |
| Jerusalem, Israel, 91031 | |
Sponsors and Collaborators
Corindus Inc.
Investigators
| Principal Investigator: | Giora Weisz, MD | Columbia University Medical Center/New York-Presbyterian Hospital | |
| Study Director: | Chris Cain | VP, Clinical Affairs |
Additional Information:
| Responsible Party: | Corindus Inc. |
| ClinicalTrials.gov Identifier: | NCT01917682 History of Changes |
| Other Study ID Numbers: |
PRECISION CorPath Registry |
| First Posted: | August 7, 2013 Key Record Dates |
| Last Update Posted: | June 12, 2017 |
| Last Verified: | June 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Corindus Inc.:
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robotic-assisted PCI coronary intervention CorPath PRECISION Registry PCI angioplasty |
Additional relevant MeSH terms:
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Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Ischemia Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |