Arterial Occlusive Diseases, Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Heart Diseases, Myocardial Ischemia, Vascular Diseases
Conditions
Keywords
robotic-assisted PCI, coronary intervention, CorPath PRECISE, PCI
Brief summary
The objective of this study is to evaluate the safety and effectiveness of the clinical and technical performance of the CorPath® 200 System in the delivery and manipulation of coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI).
Interventions
DEVICECorPath robotic-assisted PCI
CorPath 200® robotic-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: 1. Subject is between 18 and 99 years of age. 2. Subject is an acceptable candidate for PCI. 3. Subject must have clinical evidence of ischemic heart disease or a positive functional study. 4. Female subjects must be of non-child bearing potential, or if able to bear children, have a negative pregnancy test within 7 days prior to the CorPath procedure. 5. 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: 1. Study lesion is a single de novo native coronary artery lesion. This lesion may consist of multiple lesions (with 10mm or less between diseased segments) and must be completely covered by a single stent with at least 2.0mm of normal segments on proximal and distal edges of the lesion. 2. Study reference vessel diameter is between 2.5mm and 4.0mm by visual estimate. 3. Study lesion length is less than or equal to 24.0mm by visual estimate. 4. Study lesion diameter showing stenosis of at least 50% by visual estimate. General
Exclusion criteria
1. Subject requires planned PCI or CABG (Coronary Artery Bypass Graft) within 30 days following the CorPath procedure. 2. Evidence of an acute myocardial infarction within 72 hours prior to the intended CorPath procedure. 3. Subject has documented left ventricular ejection fraction \<30%. 4. Subject has undergone PCI within 72 hours prior to the CorPath procedure. 5. Subject has undergone PCI within 30 days prior to the CorPath procedure and experienced a major adverse coronary event (MACE) or a serious adverse event (SAE) as defined in the protocol. 6. Subject has known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, prasugrel, stainless steel, cobalt chromium, or sensitivity to contrast media, including Visipaque™, which cannot be adequately pre-medicated or managed with clinically appropriate substitutes. 7. Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3, or a WBC (white blood cell) count of \<3,000 cells/mm3 (e.g. thrombocytopenia, thrombocythemia, neutropenia or leukopenia). 8. Subject has a serum creatinine level of \>2.0 mg/dL or eGFR (estimated Glomerular Filtration Rate) \<30 ml/min as measured within 7 days prior to the procedure. 9. Subject has suffered a stroke within 30 days prior to planned CorPath procedure. 10. Subject has an active peptic ulcer or upper gastrointestinal bleeding within the 6 months prior to planned CorPath procedure. 11. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. 12. Subject is currently participating in another investigational drug or drug/device or device trial and has not completed the entire follow up period. 13. Femoral access is not possible. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Procedural Success | 48-hrs or hospital discharge, whichever occurs first | Defined as \<30% residual stenosis in CorPath 200 System treated lesions at the completion of the interventional procedure (including stent placement) in the absence of MACE, either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first. |
| Percentage of Patients With Device Technical Success | 1 day | Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table | 1 day | Defined as the difference between the radiation exposure measured at the procedure table (the conventional site of the primary operator) and the radiation exposure measured at the primary operator's position during the procedure. The radiation unit that was used was in milligray, but the measure is being reported as the ratio. |
Countries
Colombia, United States
Participant flow
Recruitment details
During January-December 2011 period 164 participants were enrolled in the PRECISE study at 9 clinical sites
Participants by arm
| Arm | Count |
|---|---|
| CorPath Robotic-assisted PCI CorPath 200 robotic-assisted PCI | 164 |
| Total | 164 |
Baseline characteristics
| Characteristic | CorPath Robotic-assisted PCI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 77 Participants |
| Age, Categorical Between 18 and 65 years | 87 Participants |
| Age Continuous | 64.1 years STANDARD_DEVIATION 10 |
| Region of Enrollment Colombia | 20 participants |
| Region of Enrollment United States | 144 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 62 / 164 |
| serious Total, serious adverse events | 28 / 164 |
Outcome results
Primary
Percentage of Participants With Clinical Procedural Success
Defined as \<30% residual stenosis in CorPath 200 System treated lesions at the completion of the interventional procedure (including stent placement) in the absence of MACE, either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first.
Time frame: 48-hrs or hospital discharge, whichever occurs first
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CorPath Robotic-assisted PCI | Percentage of Participants With Clinical Procedural Success | 97.6 percentage of participants |
Primary
Percentage of Patients With Device Technical Success
Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CorPath Robotic-assisted PCI | Percentage of Patients With Device Technical Success | 98.8 percentage of participants |
Secondary
The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table
Defined as the difference between the radiation exposure measured at the procedure table (the conventional site of the primary operator) and the radiation exposure measured at the primary operator's position during the procedure. The radiation unit that was used was in milligray, but the measure is being reported as the ratio.
Time frame: 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CorPath Robotic-assisted PCI | The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table | 0.42 ratio |