Peripheral Arterial DiseaseRAPIDNCT02371785

Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease

A study testing CorPath 200 System in people with Peripheral Arterial Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. 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?: CorPath 200 System
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: 3 Feb 2015to 22 May 2015
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
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 iliac and/or superficial femoral arteries;
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.

Who cannot join

General Exclusion
Failure/inability/unwillingness to provide informed consent;
Target vessel has been previously treated with bypass;
Has an abdominal aortic aneurysm contiguous with the iliac artery target lesion;
Has contraindication to anticoagulation;
Has bleeding or a hypercoagulability disorder;

Show all 19Show fewer

Thrombocytopenia;
Elevated international normalized ratio (>1.5);
Elevated serum creatinine (≥2.5 mg/dL);
Active infection;
Contraindication to contrast; or
Enrolled in concurrent clinical study.
Angiographic Exclusion
Target vessel:
shows evidence of previous dissection or perforation, or
has adjacent acute thrombus;
Lesion is highly calcified;
Lesion requires use of any atherectomy device during the procedure;
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.

Austria1 site

Medizinische Univeristät Graz
Graz, A-8036

Other trials in Austria

About this study

This study evaluates the performance of the CorPath 200 System to deliver guide wires and balloons to blockages in the arteries of the leg.

Read the 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.

Conditions: Peripheral Arterial Disease
Being tested: CorPath 200 System
Keywords: Peripheral Arterial Disease, Critical Limb Ischemia, Claudication, Percutaneous Vascular Intervention, Peripheral Vascular Intervention
Medical subject headings: Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Intermittent Claudication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CorPath 200 SystemDevice
Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).

Study groups in NCT02371785
Study group	Role	What they receive
CorPath 200 System	Experimental	CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention. Receives: Device: CorPath 200 System

What is being measured

The primary outcome is the main question the study is designed to answer.

Device Technical Success
Number of lesions for which there was technical success" as accurate and appropriate.
Measured: Procedure
Adverse Events
No device-related serious adverse events during the procedure.
Measured: Procedure

Secondary outcomes (5)

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.
Measured: 24-hours
Fluoroscopy Time
As recorded by an X-ray system utilized during the procedure.
Measured: Procedure
Contrast Volume
Total amount of contrast used during CorPath procedure.
Measured: Procedure
Total Procedure Time
Defined as the time measured from the insertion of the hemostasis sheath until procedure complete (guide catheter removed).
Measured: Procedure
Interventional Procedure Time
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Measured: Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 201522 May 2015

First posted26 Feb 2015 (estimated)
Study start3 Feb 2015
Primary completion28 Apr 2015
Study completion22 May 2015

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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02371785
Sponsor's protocol ID: 2014-002
Acronym: RAPID
Status last verified: Mar 2019
First submitted: 20 Feb 2015
Last updated: 19 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease
ClinicalTrials.gov ID: NCT02371785
Acronym / sponsor ID: RAPID / 2014-002
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease, Critical Limb Ischemia, Claudication, Percutaneous Vascular Intervention, Peripheral Vascular Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Siemens Healthineers Endovascular Robotics, Inc.Industry (pharma, biotech, devices)
Study start: 3 Feb 2015 (actual)
Primary completion: 28 Apr 2015 (actual)
Study completion: 22 May 2015 (actual)
First posted: 26 Feb 2015 (estimated)
Results: Posted 19 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CorPath 200 System	Experimental	Device: CorPath 200 SystemCorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

General Inclusion
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.

Key exclusion criteria (19 listed)

General Exclusion
Angiographic Exclusion

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
CorPath 200 SystemRemote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).	Device	CorPath 200 System

Primary outcome

Device Technical Success
Time frame: Procedure
Number of lesions for which there was technical success" as accurate and appropriate.
Adverse Events
Time frame: Procedure
No device-related serious adverse events during the procedure.

5 secondary outcomes

Clinical Procedural Success
Time frame: 24-hours
Fluoroscopy Time
Time frame: Procedure
Contrast Volume
Time frame: Procedure
Total Procedure Time
Time frame: Procedure
Interventional Procedure Time
Time frame: Procedure

Results and safety

Results posted to the registry on 19 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CorPath 200 System	20	20

Primary outcome: Device Technical Success

Time frame: Procedure. Number. Unit: lesions

Measure	CorPath 200 System n = 20
Value	29

Population analysed: 29 lesions treated in 20 subjects.

Primary outcome: Adverse Events

Time frame: Procedure. Count of participants. Unit: Participants

Measure	Device-related Periprocedural Event n = 20
Value	0

Population analysed: Device-related events that occured in subjects treated.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All subjects will be followed post-CorPath procedure through 24 hours or hospital discharge, whichever occurs first.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Device-related Periprocedural Event	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): This study represents a single high-volume tertiary care center experience and the results need to be replicated by multiple users to show the general applicability of these findings.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peripheral Arterial Disease

Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

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, M.D. principal investigator

Medizinische Universität 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 CorPath 200 System 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 6 inclusion and 19 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 19 Mar 2019. 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 19 Mar 2019). 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?

Device Technical Success (time frame: Procedure). 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?

On the ClinicalTrials.gov record for NCT02371785.

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 19 Mar 2019.