Peripheral Arterial Disease
Conditions
Keywords
Peripheral Arterial Disease, Critical Limb Ischemia, Claudication, Percutaneous Vascular Intervention, Peripheral Vascular Intervention
Brief summary
This study evaluates the performance of the CorPath 200 System to deliver guide wires and balloons to blockages in the arteries of the leg.
Detailed description
The CorPath 200 System is currently marketed for remotely delivering guide wires, balloons and stents to blockages in the coronary arteries. This study will evaluate the feasibility of CorPath 200 System to deliver guide wires and balloons to blockages in non-coronary arteries. Guide wires and balloons are delivered to blockages in the lower limbs manually by doctors.If this study shows that guide wires and balloons can be safely delivered to blockages in the lower limbs, then it will be an alternative for physicians.
Interventions
DEVICECorPath 200 System
Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).
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 1. At least 18 years of age; 2. Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in iliac and/or superficial femoral arteries; 3. The subject or the legally authorized representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent. * Angiographic Inclusion Presence of superficial femoral artery and/or iliac stenosis (\>50%) or occlusion of up to 50 mm in length as determined by angiogram prior to index interventional procedure.
Exclusion criteria
* General Exclusion 1. Failure/inability/unwillingness to provide informed consent; 2. Target vessel has been previously treated with bypass; 3. Has an abdominal aortic aneurysm contiguous with the iliac artery target lesion; 4. Has contraindication to anticoagulation; 5. Has bleeding or a hypercoagulability disorder; 6. Thrombocytopenia; 7. Elevated international normalized ratio (\>1.5); 8. Elevated serum creatinine (≥2.5 mg/dL); 9. Active infection; 10. Contraindication to contrast; or 11. Enrolled in concurrent clinical study. * Angiographic Exclusion 1. Target vessel: 1. shows evidence of previous dissection or perforation, or 2. has adjacent acute thrombus; 2. Lesion is highly calcified; 3. Lesion requires use of any atherectomy device during the procedure; 4. Has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Technical Success | Procedure | Number of lesions for which there was technical success as accurate and appropriate. |
| Adverse Events | Procedure | No device-related serious adverse events during the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Procedural Success | 24-hours | Defined as \<50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure (without an unplanned switch to the manual procedure) in the absence of device-related SAE, either within twenty-four (24) hours of the procedure or prior to hospital discharge, whichever occurs first. |
| Fluoroscopy Time | Procedure | As recorded by an X-ray system utilized during the procedure. |
| Contrast Volume | Procedure | Total amount of contrast used during CorPath procedure. |
| Total Procedure Time | Procedure | Defined as the time measured from the insertion of the hemostasis sheath until procedure complete (guide catheter removed). |
| Interventional Procedure Time | Procedure | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. |
Countries
Austria
Participant flow
Recruitment details
During February - April 2015 period 20 participants were enrolled in the RAPID study at one (1) clinical site.
Participants by arm
| Arm | Count |
|---|---|
| Baseline Demographics Baseline measures for the treated subjects. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Baseline Demographics | — |
|---|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 9.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Adverse Events
No device-related serious adverse events during the procedure.
Time frame: Procedure
Population: Device-related events that occured in subjects treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CorPath 200 System | Adverse Events | 0 Participants |
Primary
Device Technical Success
Number of lesions for which there was technical success as accurate and appropriate.
Time frame: Procedure
Population: 29 lesions treated in 20 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CorPath 200 System | Device Technical Success | 29 lesions |
Secondary
Clinical Procedural Success
Defined as \<50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure (without an unplanned switch to the manual procedure) in the absence of device-related SAE, either within twenty-four (24) hours of the procedure or prior to hospital discharge, whichever occurs first.
Time frame: 24-hours
Population: Achievement of \<50% residual stenosis in all robotic system treated lesions at the completion of the interventional procedure without an unplanned switch to the manual procedure in the absence of device-related serious adverse events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CorPath 200 System | Clinical Procedural Success | 20 participants |
Secondary
Contrast Volume
Total amount of contrast used during CorPath procedure.
Time frame: Procedure
Population: Total amount of contrast used during CorPath procedure for subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CorPath 200 System | Contrast Volume | 73.3 ml | Standard Error 9.2 |
Secondary
Fluoroscopy Time
As recorded by an X-ray system utilized during the procedure.
Time frame: Procedure
Population: Procedure time for subjects measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CorPath 200 System | Fluoroscopy Time | 6.8 min | Standard Error 3.4 |
Secondary
Interventional Procedure Time
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Time frame: Procedure
Population: Interventional procedure time for subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CorPath 200 System | Interventional Procedure Time | 23.4 min | Standard Deviation 14 |
Secondary
Total Procedure Time
Defined as the time measured from the insertion of the hemostasis sheath until procedure complete (guide catheter removed).
Time frame: Procedure
Population: Total procedure time for subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CorPath 200 System | Total Procedure Time | 45.5 min | Standard Deviation 6.2 |