Coronary Artery Disease
Conditions
Keywords
ischemia, stent
Brief 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.
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). I. 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. B. 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. B. 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. C. 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.
Interventions
DEVICECorPath 200
CorPath™ 200 robotically-assisted percutaneous coronary intervention
Sponsors
Corindus Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Procedural Success | 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 | Intervention | Successful robotic delivery and retraction of all PCI devices during CorPath PCI procedure. |
Countries
Colombia
Participant flow
Recruitment details
February-March 2011 at CORBIC, Envigado, Colombia
Participants by arm
| Arm | Count |
|---|---|
| Investigational CorPath® 200 System | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Didn't meet inclusion/exclusion criteria | 2 |
Baseline characteristics
| Characteristic | Investigational |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 67.8 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment Colombia | 8 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
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)
Time frame: 48-hrs or hospital discharge, whichever occurs first
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational | Clinical Procedural Success | 100 percentage of participants |
Primary
Procedural Technical Success
Successful robotic delivery and retraction of all PCI devices during CorPath PCI procedure.
Time frame: Intervention
Population: Total number of PCI devices.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational | Procedural Technical Success | 97.8 percentage of PCI devices |