Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions

A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness in Percutaneous Coronary Interventions

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01917682

Acronym

PRECISION

Enrollment

754

Registered

2013-08-07

Start date

2013-08-31

Completion date

2016-12-31

Last updated

2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Occlusive Diseases, Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Heart Diseases, Myocardial Ischemia, Vascular Diseases

Keywords

robotic-assisted PCI, coronary intervention, CorPath PRECISION Registry, PCI, angioplasty

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.

Detailed description

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.

Interventions

PROCEDURECorPath-assisted Percutaneous Coronary Intervention

Robotic-assisted Percutaneous Coronary Intervention

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age \>18 years. 2. Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI) with the CorPath 200 system. 3. 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

1. 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). 2. Failure/inability/unwillingness to provide informed consent.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Clinical Success	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

Measure	Time frame	Description
Number of Participants With In-hospital Major Adverse Coronary Events (MACE)	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.
Number of Participants With an Adverse Event	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

Measure	Time frame	Description
Contrast Fluid Volume	During procedure	The amount of contrast fluid used (mL) during the procedure.
Patient Radiation Exposure - Dose-Area-Product	During procedure	DAP (dose-area-product) as recorded during the procedure.
Patient Radiation Exposure - Cumulative Dose	During procedure	Cumulative dose (mGy) as recored during the procedure.
Overall Procedure Time	During procedure	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Visual Measurement of Lesion Length	During procedure	Visual estimate by clinical operator prior to delivery of PCI device(s).
CorPath Measurement of Lesion Length	During procedure	Robotic measurement of lesion length using the CorPath System performed by the Clinical Operator.
Number of Participants Who Had a Conversions to Manual Technique.	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.
PCI Procedure Time	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	During procedure	As recorded by an X-Ray System utilized during the procedure.

Countries

Israel, United States

Participant flow

Recruitment details

Patients that had a robotic-assisted PCI procedure.

Participants by arm

Arm	Count
Study Cohort Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention	754
Total	754

Baseline characteristics

Characteristic	Study Cohort
Age, Continuous	66.9 years STANDARD_DEVIATION 12.1
Sex: Female, Male Female	200 Participants
Sex: Female, Male Male	554 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 754
other Total, other adverse events	0 / 754
serious Total, serious adverse events	18 / 754

Outcome results

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).

Time frame: In-hospital (72-hours or discharge, whichever occurs first)

Population: Number of participants with complete data to assess clinical success.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Study Cohort	Number of Participants With Clinical Success	723 Participants

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.

Time frame: In-hospital (72-hours or discharge, whichever occurs first)

Population: Number of participants with complete data to assess Adverse Events.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Study Cohort	Number of Participants With an Adverse Event	18 Participants

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.

Time frame: In-hospital (72-hours or discharge, whichever occurs first)

Population: Number of participants with complete data to assess In-hospital Major Adverse Coronary Events (MACE).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Study Cohort	Number of Participants With In-hospital Major Adverse Coronary Events (MACE)	6 Participants

Other Pre-specified

Contrast Fluid Volume

The amount of contrast fluid used (mL) during the procedure.

Time frame: During procedure

Population: Number of partcipants with completed data to assess contrast fluid volume.

Arm	Measure	Value (MEAN)	Dispersion
Study Cohort	Contrast Fluid Volume	181.1 mL	Standard Deviation 90.8

Other Pre-specified

CorPath Measurement of Lesion Length

Robotic measurement of lesion length using the CorPath System performed by the Clinical Operator.

Time frame: During procedure

Population: Lesion length measured with CorPath System.

Arm	Measure	Value (MEAN)	Dispersion
Study Cohort	CorPath Measurement of Lesion Length	19.1 mm	Standard Deviation 10.6

Other Pre-specified

Fluoroscopy and/or X-Ray Time

As recorded by an X-Ray System utilized during the procedure.

Time frame: During procedure

Population: Number of participants with complete data to assess fluoroscopy and/or X-Ray time.

Arm	Measure	Value (MEAN)	Dispersion
Study Cohort	Fluoroscopy and/or X-Ray Time	15.0 min	Standard Deviation 8.4

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.

Time frame: During procedure

Population: Number of conversions from the robotic PCI to manual PCI in participants with complete data.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Study Cohort	Number of Participants Who Had a Conversions to Manual Technique.	99 Participants

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.

Time frame: During procedure

Population: Number of participants that had completed data to assess Overall procedure time.

Arm	Measure	Value (MEAN)	Dispersion
Study Cohort	Overall Procedure Time	61.9 min	Standard Deviation 28.3

Other Pre-specified

Patient Radiation Exposure - Cumulative Dose

Cumulative dose (mGy) as recored during the procedure.

Time frame: During procedure

Population: 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.

Arm	Measure	Value (MEAN)	Dispersion
Study Cohort	Patient Radiation Exposure - Cumulative Dose	1631.5 mGy	Standard Deviation 3664.5

Other Pre-specified

Patient Radiation Exposure - Dose-Area-Product

DAP (dose-area-product) as recorded during the procedure.

Time frame: During procedure

Arm	Measure	Value (MEAN)	Dispersion
Study Cohort	Patient Radiation Exposure - Dose-Area-Product	120861.3 mGy*cm2	Standard Deviation 256522.9

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.

Time frame: During procedure

Population: Number of participants that had complete data to assess PCI procedure time.

Arm	Measure	Value (MEAN)	Dispersion
Study Cohort	PCI Procedure Time	43.6 min	Standard Deviation 23.1

Other Pre-specified

Visual Measurement of Lesion Length

Visual estimate by clinical operator prior to delivery of PCI device(s).

Time frame: During procedure

Population: Operator visual lesion length estimate.

Arm	Measure	Value (MEAN)	Dispersion
Study Cohort	Visual Measurement of Lesion Length	17.3 mm	Standard Deviation 9.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Recruitment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Number of Participants With Clinical Success

Number of Participants With an Adverse Event

Number of Participants With In-hospital Major Adverse Coronary Events (MACE)

Contrast Fluid Volume

CorPath Measurement of Lesion Length

Fluoroscopy and/or X-Ray Time

Number of Participants Who Had a Conversions to Manual Technique.

Overall Procedure Time

Patient Radiation Exposure - Cumulative Dose

Patient Radiation Exposure - Dose-Area-Product

PCI Procedure Time

Visual Measurement of Lesion Length