Trial Outcomes & Findings for Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions (NCT NCT01917682)

Results Overview

Less than 30% residual stenosis post PCI in the lesion(s) treated with the CorPath system, without in-hospital major adverse coronary events (MACE).

Recruitment status

COMPLETED

Target enrollment

754 participants

Primary outcome timeframe

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

Results posted on

2020-12-22

Participant Flow

Patients that had a robotic-assisted PCI procedure.

Participant milestones

Participant milestones
Measure	Study Cohort Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Overall Study STARTED	754
Overall Study COMPLETED	754
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Cohort n=754 Participants Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Age, Continuous	66.9 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	200 Participants n=5 Participants
Sex: Female, Male Male	554 Participants n=5 Participants

PRIMARY outcome

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

Population: Number of participants with complete data to assess 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).

Outcome measures

Outcome measures
Measure	Study Cohort n=743 Participants Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Number of Participants With Clinical Success	723 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Study Cohort n=754 Participants Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Number of Participants With In-hospital Major Adverse Coronary Events (MACE)	6 Participants

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Study Cohort n=754 Participants Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Number of Participants With an Adverse Event	18 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During procedure

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

Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.

Outcome measures

Outcome measures
Measure	Study Cohort n=722 Participants Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Overall Procedure Time	61.9 min Standard Deviation 28.3

OTHER_PRE_SPECIFIED outcome

Timeframe: During procedure

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

Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.

Outcome measures

Outcome measures
Measure	Study Cohort n=696 Participants Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
PCI Procedure Time	43.6 min Standard Deviation 23.1

OTHER_PRE_SPECIFIED outcome

Timeframe: During procedure

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

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

Outcome measures

Outcome measures
Measure	Study Cohort n=753 Participants Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Fluoroscopy and/or X-Ray Time	15.0 min Standard Deviation 8.4

OTHER_PRE_SPECIFIED outcome

Timeframe: During procedure

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

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

Outcome measures

Outcome measures
Measure	Study Cohort n=750 Participants Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Contrast Fluid Volume	181.1 mL Standard Deviation 90.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Study Cohort n=635 Participants Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Patient Radiation Exposure - Dose-Area-Product	120861.3 mGy*cm2 Standard Deviation 256522.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Cumulative dose (mGy) as recored during the procedure.

Outcome measures

Outcome measures
Measure	Study Cohort n=679 Participants Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Patient Radiation Exposure - Cumulative Dose	1631.5 mGy Standard Deviation 3664.5

OTHER_PRE_SPECIFIED outcome

Timeframe: During procedure

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

The overall number of conversions from the robotic PCI to manual PCI will be captured to analyze the technical success of the device.

Outcome measures

Outcome measures
Measure	Study Cohort n=948 Participants Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Number of Participants Who Had a Conversions to Manual Technique.	99 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During procedure

Population: Operator visual lesion length estimate.

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

Outcome measures

Outcome measures
Measure	Study Cohort n=557 Lesions Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Visual Measurement of Lesion Length	17.3 mm Standard Deviation 9.8

OTHER_PRE_SPECIFIED outcome

Timeframe: During procedure

Population: Lesion length measured with CorPath System.

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

Outcome measures

Outcome measures
Measure	Study Cohort n=557 lesions Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
CorPath Measurement of Lesion Length	19.1 mm Standard Deviation 10.6

Adverse Events

Study Cohort

Serious events: 18 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study Cohort n=754 participants at risk Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Cardiac disorders TRANSIENT BRADYCARDIA/HYPOTENSION	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Cardiac disorders FLUID RETENSION	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Cardiac disorders RECURRENT CHEST, RIGHT SHOULDER, RIGHT ARM PAIN	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Gastrointestinal disorders ACUTE NAUSEA AND VOMITING	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Renal and urinary disorders URINARY TRACT INFECTION	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Cardiac disorders DISSECTION DURING MANUAL PCI LESION #2	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Cardiac disorders LEFT MAIN DISSECTION	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Cardiac disorders ABRUPT VESSEL CLOSURE, DUE TO ANGIOPLASTY DISSECTION	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Renal and urinary disorders URINARY RETENTION	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Cardiac disorders PERI-PROCEDURAL MI; NSTEMI/NON QWAVE MI	0.53% 4/754 • Number of events 4 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Cardiac disorders PEA ARREST	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Nervous system disorders ACUTE CEREBROVASCULAR ACCIDENT (CVA)	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Cardiac disorders CONTRAST DYE ALLERGIC REACTION; HYPOTENSION	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Renal and urinary disorders HEMATOCHEZIA	0.13% 1/754 • Number of events 1 • Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.

Other adverse events

Adverse event data not reported

Additional Information

John Van Vleet, VP of Clinical and Regulatory Affairs

Corindus, Inc.

Phone: (260)615-8892

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place