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

• Sponsor: Corindus Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01917682
• Collaborator: (none)
• Enrollment: 754
• Locations: 16
• Actual Duration (Months): 40
• Patients Per Site: 47.1
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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	Phase
Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases	Procedure: CorPath-assisted Percutaneous Coronary Intervention

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 754 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness in Percutaneous Coronary Interventions
• Actual Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Study Cohort Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)	Procedure: CorPath-assisted Percutaneous Coronary Intervention; Robotic-assisted Percutaneous Coronary Intervention; Other Names: Robotic-assisted Percutaneous Coronary Intervention

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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 Outcome Measures

1. Overall Procedure Time [During procedure]

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

2. PCI Procedure Time [During procedure]

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

3. Fluoroscopy and/or X-Ray Time [During procedure]

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

4. Contrast Fluid Volume [During procedure]

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

5. Patient Radiation Exposure - Dose-Area-Product [During procedure]

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

6. Patient Radiation Exposure - Cumulative Dose [During procedure]

   Cumulative dose (mGy) as recored during the procedure.

7. 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.

8. Visual Measurement of Lesion Length [During procedure]

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

9. CorPath Measurement of Lesion Length [During procedure]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC San Diego Medical Center	San Diego	California	United States	92103
2	Valley View Hospital	Glenwood Springs	Colorado	United States	81601
3	Medstar Washington Hospital Center	Washington	District of Columbia	United States	20010
4	Orlando Regional Medical Center	Orlando	Florida	United States	32806
5	North Georgia Heart Foundation	Gainesville	Georgia	United States	30501
6	St. Elizabeth's Medical Center	Boston	Massachusetts	United States	02135
7	Spectrum Health System	Grand Rapids	Michigan	United States	49503
8	Mayo Clinic	Rochester	Minnesota	United States	55906
9	Columbia University Medical Center/New York-Presbyterian Hospital	New York	New York	United States	10032
10	St. Joseph's Hospital Health Center	Syracuse	New York	United States	13203
11	Carolinas Medical Center - Northeast	Concord	North Carolina	United States	28203
12	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106
13	Sanford Health	Sioux Falls	South Dakota	United States	57104
14	University of Virginia	Charlottesville	Virginia	United States	22908
15	Virginia Commonwealth Univ. Medical Center	Richmond	Virginia	United States	23298
16	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Visit the Corindus website for related information.

Publications

None provided.

• Responsible Party: Corindus Inc.
• ClinicalTrials.gov Identifier: NCT01917682
• Other Study ID Numbers: PRECISION CorPath Registry
• First Posted: Aug 7, 2013
• Last Update Posted: Dec 22, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Corindus Inc.: robotic-assisted PCI; coronary intervention; CorPath PRECISION Registry; PCI; angioplasty
• Additional relevant MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Ischemia

Study Results

Participant Flow

Recruitment Details	Patients that had a robotic-assisted PCI procedure.

Arm/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Period Title: Overall Study
STARTED	754
COMPLETED	754
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Overall Participants	754
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.9 (12.1)
Sex: Female, Male (Count of Participants)
Female	200 26.5%
Male	554 73.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Clinical Success
Description	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)

Outcome Measure Data

Analysis Population Description

Number of participants with complete data to assess clinical success.

Arm/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Measure Participants	743
Count of Participants [Participants]	723 95.9%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Measure Participants	754
Count of Participants [Participants]	6 0.8%

3. Secondary Outcome

Title	Number of Participants With an Adverse Event
Description	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)

Outcome Measure Data

Analysis Population Description

Number of participants with complete data to assess Adverse Events.

Arm/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Measure Participants	754
Count of Participants [Participants]	18 2.4%

4. Other Pre-specified Outcome

Title	Overall Procedure Time
Description	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Measure Participants	722
Mean (Standard Deviation) [min]	61.9 (28.3)

5. Other Pre-specified Outcome

Title	PCI Procedure Time
Description	Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Measure Participants	696
Mean (Standard Deviation) [min]	43.6 (23.1)

6. Other Pre-specified Outcome

Title	Fluoroscopy and/or X-Ray Time
Description	As recorded by an X-Ray System utilized during the procedure.
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Measure Participants	753
Mean (Standard Deviation) [min]	15.0 (8.4)

7. Other Pre-specified Outcome

Title	Contrast Fluid Volume
Description	The amount of contrast fluid used (mL) during the procedure.
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Measure Participants	750
Mean (Standard Deviation) [mL]	181.1 (90.8)

8. Other Pre-specified Outcome

Title	Patient Radiation Exposure - Dose-Area-Product
Description	DAP (dose-area-product) as recorded during the procedure.
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

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/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Measure Participants	635
Mean (Standard Deviation) [mGy*cm2]	120861.3 (256522.9)

9. Other Pre-specified Outcome

Title	Patient Radiation Exposure - Cumulative Dose
Description	Cumulative dose (mGy) as recored during the procedure.
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

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/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Measure Participants	679
Mean (Standard Deviation) [mGy]	1631.5 (3664.5)

10. Other Pre-specified Outcome

Title	Number of Participants Who Had a Conversions to Manual Technique.
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Measure Participants	948
Count of Participants [Participants]	99 13.1%

11. Other Pre-specified Outcome

Title	Visual Measurement of Lesion Length
Description	Visual estimate by clinical operator prior to delivery of PCI device(s).
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

Operator visual lesion length estimate.

Arm/Group Title	Visual Estimate
Arm/Group Description	Operator visual estimate of lesion length.
Measure Participants	754
Measure Lesions	557
Mean (Standard Deviation) [mm]	17.3 (9.8)

12. Other Pre-specified Outcome

Title	CorPath Measurement of Lesion Length
Description	Robotic measurement of lesion length using the CorPath System performed by the Clinical Operator.
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

Lesion length measured with CorPath System.

Arm/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
Measure Participants	754
Measure lesions	557
Mean (Standard Deviation) [mm]	19.1 (10.6)

Adverse Events

Time Frame	Adverse events were assessed from the index procedure though participant discharged from the hospital or 72-hours post procedure, whichever occurred first.
Arm/Group Title	Study Cohort
Arm/Group Description	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention
All Cause Mortality
	Study Cohort
	Affected / at Risk (%)	# Events
Total	0/754 (0%)
Serious Adverse Events
	Study Cohort
	Affected / at Risk (%)	# Events
Total	18/754 (2.4%)
Cardiac disorders
TRANSIENT BRADYCARDIA/HYPOTENSION	1/754 (0.1%)	1
FLUID RETENSION	1/754 (0.1%)	1
RECURRENT CHEST, RIGHT SHOULDER, RIGHT ARM PAIN	1/754 (0.1%)	1
DISSECTION DURING MANUAL PCI LESION #2	1/754 (0.1%)	1
LEFT MAIN DISSECTION	1/754 (0.1%)	1
ABRUPT VESSEL CLOSURE, DUE TO ANGIOPLASTY DISSECTION	1/754 (0.1%)	1
PERI-PROCEDURAL MI; NSTEMI/NON QWAVE MI	4/754 (0.5%)	4
PEA ARREST	1/754 (0.1%)	1
CONTRAST DYE ALLERGIC REACTION; HYPOTENSION	1/754 (0.1%)	1
Gastrointestinal disorders
ACUTE NAUSEA AND VOMITING	1/754 (0.1%)	1
Nervous system disorders
ACUTE CEREBROVASCULAR ACCIDENT (CVA)	1/754 (0.1%)	1
Renal and urinary disorders
URINARY TRACT INFECTION	1/754 (0.1%)	1
URINARY RETENTION	1/754 (0.1%)	1
HEMATOCHEZIA	1/754 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS	1/754 (0.1%)	1
Other (Not Including Serious) Adverse Events
	Study Cohort
	Affected / at Risk (%)	# Events
Total	0/754 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.