Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and performance of the CorPath 200 System in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in percutaneous vascular interventions.
This is a prospective, single-arm, single center, non-randomized feasibility study of the CorPath 200 System to examine its performance during complete interventions (DCB, Stenting) of the femoropopliteal arteries and patient outcomes at 30 days.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-assisted PVI | Other | Robotic-assisted peripheral vascular intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted peripheral vascular intervention | Device | Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | Defined as <50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure in the absence of device-related serious adverse events (SAE). | 72 hours or hospital discharge, whichever comes first. |
| Adverse Events | No device-related serious adverse events. | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Operator Radiation Exposure Dose | Physician operator radiation exposure as recorded on personal Enterprise Dose Dashboard (EDD; Landauer) dosimeters | Procedure |
| Patient Radiation Exposure Dose |
Not provided
Inclusion Criteria:
General Inclusion Criteria
Angiographic Inclusion Criteria Femoropopliteal artery lesion(s) with stenosis (>50%) or occlusion of up to 120 mm in length as determined by imaging (MRA or Angio) prior to index interventional procedure.
Exclusion Criteria:
General Exclusion Criteria
If any of the following criteria are met, the subject cannot be enrolled in this study:
Angiographic Exclusion Criteria
• Target vessel:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marianne Brodmann, MD | Medizinische Universtität Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Univeristät Graz | Graz | A-8036 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Robotic-assisted PVI | Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Robotic-assisted PVI | Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Success | Defined as <50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure in the absence of device-related serious adverse events (SAE). | Posted | Count of Participants | Participants | 72 hours or hospital discharge, whichever comes first. |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robotic-assisted PVI | Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access-site Hematoma | Skin and subcutaneous tissue disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Corindus, Inc. | (757) 910-4818 | tina.ridgeway@corindus.com |
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patient Radiation Dose-area-product (DAP)
| Procedure |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Adverse Events | No device-related serious adverse events. | Posted | Count of Participants | Participants | Procedure |
|
|
|
| Secondary | Operator Radiation Exposure Dose | Physician operator radiation exposure as recorded on personal Enterprise Dose Dashboard (EDD; Landauer) dosimeters | Posted | Mean | Standard Deviation | μSv | Procedure |
|
|
|
| Secondary | Patient Radiation Exposure Dose | Patient Radiation Dose-area-product (DAP) | Posted | Mean | Standard Deviation | Gy•m^2 | Procedure |
|
|
|
| 0 |
| 20 |
| 3 |
| 20 |
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |