Coronary Artery DiseasePRECISIONNCT01917682

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

An observational study of Coronary Artery Disease and Coronary Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
What is being tested?: CorPath-assisted Percutaneous Coronary Intervention
Type of treatment: Surgery or procedure
How many people: 754 participants
Where: 16 sitesin 2 countries
Study dates: Aug 2013to Dec 2016
How long will I take part?: 3 Days
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects with coronary artery disease and with the clinical indication for Percutaneous Coronary Intervention (PCI).

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

16 sites in 2 countries.

Country

City, postcode or hospital

16 sites in 2 countries

United States15 sites

St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
University of Virginia
Charlottesville, Virginia, 22908
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Carolinas Medical Center - Northeast
Concord, North Carolina, 28203
North Georgia Heart Foundation
Gainesville, Georgia, 30501
Valley View Hospital
Glenwood Springs, Colorado, 81601
Spectrum Health System
Grand Rapids, Michigan, 49503
Columbia University Medical Center/New York-Presbyterian Hospital
New York, New York, 10032
Orlando Regional Medical Center
Orlando, Florida, 32806
Virginia Commonwealth Univ. Medical Center
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55906
UC San Diego Medical Center
San Diego, California, 92103
Sanford Health
Sioux Falls, South Dakota, 57104
St. Joseph's Hospital Health Center
Syracuse, New York, 13203
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010

Other trials in United States

Israel1 site

Shaare Zedek Medical Center
Jerusalem, 91031

Other trials in Israel

About this study

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

Read the 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.

Conditions: Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
Being tested: CorPath-assisted Percutaneous Coronary Intervention
Keywords: robotic-assisted PCI, coronary intervention, CorPath PRECISION Registry, PCI, angioplasty
Medical subject headings: Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CorPath-assisted Percutaneous Coronary InterventionProcedure or surgery
Also called Robotic-assisted Percutaneous Coronary Intervention
Robotic-assisted Percutaneous Coronary Intervention

Study groups in NCT01917682
Study group	Role	What they receive
Study Cohort		Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) Receives: Procedure: CorPath-assisted Percutaneous Coronary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Dec 2016

First posted7 Aug 2013 (estimated)
Study startAug 2013
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 754 participants (actual)
Target duration: 3 Days

IDs, dates and publications

ClinicalTrials.gov ID: NCT01917682
Sponsor's protocol ID: PRECISION CorPath Registry
Acronym: PRECISION
Status last verified: Dec 2020
First submitted: 2 Aug 2013
Last updated: 22 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
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Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness in Percutaneous Coronary Interventions
ClinicalTrials.gov ID: NCT01917682
Acronym / sponsor ID: PRECISION / PRECISION CorPath Registry
Conditions: Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
Keywords: robotic-assisted PCI, coronary intervention, CorPath PRECISION Registry, PCI, angioplasty
Study type: Observational
Recruitment status: Completed
Enrolment: 754 participants (actual)
Lead sponsor: Siemens Healthineers Endovascular Robotics, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2013 (actual)
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 7 Aug 2013 (estimated)
Results: Posted 2 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Other
Target follow-up: 3 Days
Number of arms: 1

Arm	Type	Receives
Study Cohort	–	Procedure: CorPath-assisted Percutaneous Coronary InterventionSubjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects with coronary artery disease and with the clinical indication for Percutaneous Coronary Intervention (PCI).

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CorPath-assisted Percutaneous Coronary InterventionAlso: Robotic-assisted Percutaneous Coronary InterventionRobotic-assisted Percutaneous Coronary Intervention	Procedure or surgery	Study Cohort

Primary outcome

Number of Participants With 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).

2 secondary outcomes

Number of Participants With In-hospital Major Adverse Coronary Events (MACE)
Time frame: In-hospital (72-hours or discharge, whichever occurs first)
Number of Participants With an Adverse Event
Time frame: In-hospital (72-hours or discharge, whichever occurs first)

Results and safety

Results posted to the registry on 2 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Cohort	754	754

Primary outcome: Number of Participants With Clinical Success

Time frame: In-hospital (72-hours or discharge, whichever occurs first). Count of participants. Unit: Participants

Measure	Study Cohort n = 743
Value	723

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

2 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Cohort	18 of 754 (2.4%)	0 of 754 (0%)	0 of 754

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Coronary Artery Disease

Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Giora Weisz, MD principal investigator

Columbia University Medical Center/New York-Presbyterian Hospital

Chris Cain study director

VP, Clinical Affairs

16 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Coronary Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinical Success (time frame: In-hospital (72-hours or discharge, whichever occurs first)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01917682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.