Back to resultsRobotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II (RAPID II)
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Robotic-assisted peripheral vascular intervention
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
General Inclusion Criteria
- At least 18 years of age;
- Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in the femoropopliteal arteries; and
- The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.
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:
- Failure/inability/unwillingness to provide informed consent;
- Target vessel has been previously treated with bypass; or
- Enrolled in concurrent clinical study.
Angiographic Exclusion Criteria
• Target vessel:
- Shows evidence of previous dissection or perforation, or
- Has adjacent acute thrombus; or
- Has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.
Sites / Locations
- Medizinische Univeristät Graz
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Robotic-assisted PVI
Arm Description
Robotic-assisted peripheral vascular intervention
Outcomes
Primary Outcome Measures
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).
Adverse Events
No device-related serious adverse events.
Secondary Outcome Measures
Operator Radiation Exposure Dose
Physician operator radiation exposure as recorded on personal Enterprise Dose Dashboard (EDD; Landauer) dosimeters
Patient Radiation Exposure Dose
Patient Radiation Dose-area-product (DAP)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02742077
Brief Title
Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II
Acronym
RAPID II
Official Title
CorPath® 200 RAPID II Study (Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corindus Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic-assisted PVI
Arm Type
Other
Arm Description
Robotic-assisted peripheral vascular intervention
Intervention Type
Device
Intervention Name(s)
Robotic-assisted peripheral vascular intervention
Intervention Description
Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
Primary Outcome Measure Information:
Title
Clinical Success
Description
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).
Time Frame
72 hours or hospital discharge, whichever comes first.
Title
Adverse Events
Description
No device-related serious adverse events.
Time Frame
Procedure
Secondary Outcome Measure Information:
Title
Operator Radiation Exposure Dose
Description
Physician operator radiation exposure as recorded on personal Enterprise Dose Dashboard (EDD; Landauer) dosimeters
Time Frame
Procedure
Title
Patient Radiation Exposure Dose
Description
Patient Radiation Dose-area-product (DAP)
Time Frame
Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
General Inclusion Criteria
At least 18 years of age;
Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in the femoropopliteal arteries; and
The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.
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:
Failure/inability/unwillingness to provide informed consent;
Target vessel has been previously treated with bypass; or
Enrolled in concurrent clinical study.
Angiographic Exclusion Criteria
• Target vessel:
Shows evidence of previous dissection or perforation, or
Has adjacent acute thrombus; or
Has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Brodmann, MD
Organizational Affiliation
Medizinische Universtität Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Univeristät Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II
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