Peripheral Arterial DiseaseRAPID IINCT02742077
Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II
A study testing Robotic-assisted peripheral vascular intervention in people with Peripheral Arterial Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Robotic-assisted peripheral vascular intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CorPath® 200 RAPID II Study (Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease)
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Robotic-assisted peripheral vascular intervention
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted peripheral vascular interventionDevice
Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted PVI | Other | Robotic-assisted peripheral vascular intervention Receives: Device: Robotic-assisted peripheral vascular intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 72 hours or hospital discharge, whichever comes first.
Adverse Events
No device-related serious adverse events.
Measured: Procedure
Secondary outcomes (2)
Operator Radiation Exposure Dose
Physician operator radiation exposure as recorded on personal Enterprise Dose Dashboard (EDD; Landauer) dosimeters
Measured: Procedure
Patient Radiation Exposure Dose
Patient Radiation Dose-area-product (DAP)
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marianne Brodmann, MD, Principal investigator, Medizinische Universtität Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742077
- Sponsor's protocol ID
- 2016-01
- Acronym
- RAPID II
- Status last verified
- Oct 2020
- First submitted
- 12 Apr 2016
- Last updated
- 4 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorPath® 200 RAPID II Study (Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease)
- ClinicalTrials.gov ID
- NCT02742077
- Acronym / sponsor ID
- RAPID II / 2016-01
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Posted 4 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted PVI | Other | Device: Robotic-assisted peripheral vascular interventionRobotic-assisted peripheral vascular intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- General Exclusion Criteria
- Failure/inability/unwillingness to provide informed consent;
- Target vessel has been previously treated with bypass; or
- Enrolled in concurrent clinical study.
- Angiographic Exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted peripheral vascular interventionRemote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions. | Device | Robotic-assisted PVI |
Primary outcome
Clinical Success
Time frame: 72 hours or hospital discharge, whichever comes first.
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
Time frame: Procedure
No device-related serious adverse events.
2 secondary outcomes
Operator Radiation Exposure Dose
Time frame: Procedure
Patient Radiation Exposure Dose
Time frame: Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Brodmann, MD principal investigator
Medizinische Universtität Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted peripheral vascular intervention in people with Peripheral Arterial Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (time frame: 72 hours or hospital discharge, whichever comes first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.