Coronary Artery DiseasePhase 2NCT01076036
CorPath™ 200: Robotically-Assisted Percutaneous Coronary Intervention (PCI)
A Phase 2 study testing CorPath 200 in people with Coronary Artery Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 1 site in Colombia.
Trial summary
An open-label, prospective, single-arm study is designed to evaluate safety, clinical and technical efficacy of the CorPath 200 System in delivery and manipulation of the coronary guide wires and balloon/stent systems for use in robotically-assisted, percutaneous coronary intervention (PCI) procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CorPath 200
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteColombia
- Study dates
- Feb 2010to May 2010
- Phase
- Phase 2
- 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
General Inclusion Criteria:
- The subject is an acceptable candidate for PCI.
- The subject must have clinical evidence of ischemic heart disease or a positive functional study.
- Female subjects must be of non-child bearing potential, or if able to bear children, have a negative pregnancy test within seven (7) days prior to index procedure.
- The subject or the legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.
Angiographic Inclusion Criteria:
- Study lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated)
- The study lesion is intended to be treated with one stent. Maximum stent length allowed is 20 mm.
- The study reference vessel diameter is between 2.50 mm and 4.5 mm by visual estimate.
- Study lesion diameter showing significant stenosis of at least 50% by visual estimate.
General Exclusion Criteria:
- Subject requires planned PCI or CABG within 30 days following the index procedure.
- Subject has evolving ST elevation myocardial infarction (STEMI) (i.e., beginning of MI symptoms within 72 hours prior to the planned index procedure).
- Subject has documented left ventricular ejection fraction < 30%.
- Subject has known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, stainless steel, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- Subject has a platelet count < 100,000 cell/mm3 or > 700,000 cell/ mm3, a WBC of < 3000 cell/ mm3 (e.g. thrombocytopenia, thrombocythemia, neutropenia or leucopenia).
- Subject has a history of a stroke (CVA) or TIA within 30-days prior to planned index procedure.
- Subject has an active peptic ulcer or upper GI bleeding within the 6 months prior to planned index procedure.
- Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Subject is currently participating in another investigational drug l drug or device trial that has not completed the entire follow up period.
Angiographic Exclusion Criteria:
- Study lesion that cannot be fully covered by a single stent of maximal length
- Subject requires treatment of multiple lesions in the study vessel at the time of index procedure.
- The study lesion requires planned treatment with DCA, laser, rotational atherectomy, or any device except for balloon dilatation prior to stent placement.
- The study vessel has evidence of intraluminal thrombus or moderate to severe tortuosity (> 90o) proximal to the target lesion.
- The study lesion has any of the following characteristics:
- Total occlusion
- Ostial location
- Involves a side branch > 2.0 mm vessel diameter
- Is located at >45° bend in the vessel
- Is moderately to severely calcified
- Moderate-to-severe calcification at the part of the vessel prior to target lesion
- Unprotected left main coronary artery disease (an obstruction greater than 50% diameter stenosis in the left main coronary artery).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CorPath™ 200 System: Coronary Remote Catheterization Feasibility Study
An open-label, prospective, single-arm study is designed to evaluate safety, clinical and technical efficacy of the CorPath 200 System in delivery and manipulation of the coronary guide wires and balloon/stent systems for use in robotically-assisted, percutaneous coronary intervention (PCI) procedures.
Read the detailed description
Objective The study objective was to evaluate the safety and technical efficacy of the CorPath 200 System in delivery and manipulation of commercially available coronary guidewires and rapid exchange balloon/stent catheter for use in percutaneous coronary interventions (PCI).
- Primary Endpoints A. Efficacy Device Clinical Success: Achievement of a < 30% final diameter stenosis after utilizing the CorPathTM 200 System to deliver a PTCA balloon and then stent to the target lesion, and successfully retract the devices without the occurrence of any In-Hospital MACE (Major Adverse Cardiac Event) evaluated at 48 hours post procedure or hospital discharge, whichever occurs first.
- Safety In-Hospital MACE: Defined as the composite of death (all cause mortality), recurrent MI, and target vessel revascularization (emergent coronary artery bypass surgery [CABG] or PCI) evaluated at 48 hours post procedure or hospital discharge, whichever occurs first.
II. Secondary Endpoints A. Efficacy CorPath Success: Ability to navigate the guide wire and balloon/stent system utilizing the CorPath™ device to the target site without the occurrence of any In-Hospital MACE, evaluated at 48 hours post index procedure or hospital discharge, whichever occurs first.
Subject Clinical Success: Achievement of a <30% final diameter stenosis of target lesion after treatment with PTCA/coronary stent without the occurrence of any In-Hospital MACE, evaluated at 48 hours post-index procedure or hospital discharge, whichever occurs first.
- Safety:
MACE at 30 Days: Defined as the composite of death, recurrent MI and/or target vessel revascularization (emergent coronary artery bypass surgery [CABG] or PCI) evaluated at 30 days post index procedure.
Adverse Events:
A summary of all adverse events observed in the trial summarized as either serious or non-serious and summarized by attribution.
- Clinical Utility
Procedure Attributes:
- Reduction in radiation exposure to the primary operator based on radiation dosimetry measurements at the procedure table and on a primary operator.
- Total Procedure time based on the time of insertion of hemostasis sheath through the time of final guide catheter withdrawal.
CorPath Device Attributes:
Subjective assessment by the operator of the following device performance attributes:
- Movement of the guide wire (rotating and advancing) to the target.
- Maneuvering and position of the guide wire to the target.
- Movement of the stent/balloon (advancing) to the target.
- Ability to deliver the PTCA/stent system to the intended target lesion.
- Ease of use of the system by the interventional team.
Material \& Methods Corindus obtained approval (from the CORBIC Ethics Committee and INVIMA - Colombian Ministry of Health) in 2009 to conduct the clinical study "CorPath™ 200 System: Coronary Remote Catheterization Feasibility Study" at CORBIC Cardio-Neuro-Vascular Institute, Envigado, Colombia.
The study is a single arm, open label, prospective registry to treat a de novo lesion (2.5 mm - 4.0 mm in diameter, 25.0 mm in length with >50% stenosis) utilizing the CorPath 200 System to deliver, manipulate and retrieve a guidewire and a balloon/stent catheter system.
- Conditions
- Coronary Artery Disease
- Being tested
- CorPath 200
- Keywords
- ischemia, stent
- Medical subject headings
- Coronary Artery Disease, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorPath 200Device
CorPath™ 200 robotically-assisted percutaneous coronary intervention
CorPath 200Device
CorPath PCI - robotic-assisted percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| CorPath 200 System | Experimental | Robotic-assisted PCI with the CorPath 200 Receives: Device: CorPath 200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Procedural Success
The percentage of Participants with <30% final diameter stenosis of the target lesion without in-hospital major adverse cardiovascular events (MACE) (defined as the composite of death, recurrent MI, and target vessel revascularization)
Measured: 48-hrs or hospital discharge, whichever occurs first
Procedural Technical Success
Successful robotic delivery and retraction of all PCI devices during CorPath PCI procedure.
Measured: Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionMay 2010
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan F Granada, MD, Principal investigator, CORBIC and CRF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076036
- Sponsor's protocol ID
- Corindus-Corbic-2010
- Status last verified
- Aug 2015
- First submitted
- 24 Feb 2010
- Last updated
- 7 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorPath™ 200 System: Coronary Remote Catheterization Feasibility Study
- ClinicalTrials.gov ID
- NCT01076036
- Acronym / sponsor ID
- Corindus-Corbic-2010
- Conditions
- Coronary Artery Disease
- Keywords
- ischemia, stent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Posted 7 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, prospective, single-arm study is designed to evaluate safety, clinical and technical efficacy of the CorPath 200 System in delivery and manipulation of the coronary guide wires and balloon/stent systems for use in robotically-assisted, percutaneous coronary intervention (PCI) procedures.
Detailed description
Objective The study objective was to evaluate the safety and technical efficacy of the CorPath 200 System in delivery and manipulation of commercially available coronary guidewires and rapid exchange balloon/stent catheter for use in percutaneous coronary interventions (PCI).
- Primary Endpoints A. Efficacy Device Clinical Success: Achievement of a < 30% final diameter stenosis after utilizing the CorPathTM 200 System to deliver a PTCA balloon and then stent to the target lesion, and successfully retract the devices without the occurrence of any In-Hospital MACE (Major Adverse Cardiac Event) evaluated at 48 hours post procedure or hospital discharge, whichever occurs first.
- Safety In-Hospital MACE: Defined as the composite of death (all cause mortality), recurrent MI, and target vessel revascularization (emergent coronary artery bypass surgery [CABG] or PCI) evaluated at 48 hours post procedure or hospital discharge, whichever occurs first.
II. Secondary Endpoints A. Efficacy CorPath Success: Ability to navigate the guide wire and balloon/stent system utilizing the CorPath™ device to the target site without the occurrence of any In-Hospital MACE, evaluated at 48 hours post index procedure or hospital discharge, whichever occurs first.
Subject Clinical Success: Achievement of a <30% final diameter stenosis of target lesion after treatment with PTCA/coronary stent without the occurrence of any In-Hospital MACE, evaluated at 48 hours post-index procedure or hospital discharge, whichever occurs first.
- Safety:
MACE at 30 Days: Defined as the composite of death, recurrent MI and/or target vessel revascularization (emergent coronary artery bypass surgery [CABG] or PCI) evaluated at 30 days post index procedure.
Adverse Events:
A summary of all adverse events observed in the trial summarized as either serious or non-serious and summarized by attribution.
- Clinical Utility
Procedure Attributes:
- Reduction in radiation exposure to the primary operator based on radiation dosimetry measurements at the procedure table and on a primary operator.
- Total Procedure time based on the time of insertion of hemostasis sheath through the time of final guide catheter withdrawal.
CorPath Device Attributes:
Subjective assessment by the operator of the following device performance attributes:
- Movement of the guide wire (rotating and advancing) to the target.
- Maneuvering and position of the guide wire to the target.
- Movement of the stent/balloon (advancing) to the target.
- Ability to deliver the PTCA/stent system to the intended target lesion.
- Ease of use of the system by the interventional team.
Material \& Methods Corindus obtained approval (from the CORBIC Ethics Committee and INVIMA - Colombian Ministry of Health) in 2009 to conduct the clinical study "CorPath™ 200 System: Coronary Remote Catheterization Feasibility Study" at CORBIC Cardio-Neuro-Vascular Institute, Envigado, Colombia.
The study is a single arm, open label, prospective registry to treat a de novo lesion (2.5 mm - 4.0 mm in diameter, 25.0 mm in length with >50% stenosis) utilizing the CorPath 200 System to deliver, manipulate and retrieve a guidewire and a balloon/stent catheter system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CorPath 200 System | Experimental | Device: CorPath 200Robotic-assisted PCI with the CorPath 200 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 200CorPath™ 200 robotically-assisted percutaneous coronary intervention | Device | CorPath 200 System |
| CorPath 200CorPath PCI - robotic-assisted percutaneous coronary intervention | Device | CorPath 200 System |
Primary outcome
Clinical Procedural Success
Time frame: 48-hrs or hospital discharge, whichever occurs first
The percentage of Participants with <30% final diameter stenosis of the target lesion without in-hospital major adverse cardiovascular events (MACE) (defined as the composite of death, recurrent MI, and target vessel revascularization)
Procedural Technical Success
Time frame: Intervention
Successful robotic delivery and retraction of all PCI devices during CorPath PCI procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Juan F Granada, MD principal investigator
CORBIC and CRF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CorPath 200 in people with Coronary Artery Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2015). 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?
Clinical Procedural Success (time frame: 48-hrs or hospital discharge, whichever occurs first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2015; AzTrials last refreshed its copy on 27 Oct 2026.