Peripheral Vascular DiseaseROVERNCT01984437
Registry of the Magellan Robotic System
An observational study of Peripheral Vascular Disease, run by Hansen Medical at 7 sites in 3 countries.
Trial summary
The purpose of the registry is to gather both retrospective and prospective case data on the use of the commercially available Magellan Robotic System and Magellan Robotic Catheters in accordance with the approved intended use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- How many people
- 348 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Nov 2013to Aug 2016
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Subjects must be diagnosed with vascular disease in the peripheral vasculature, meet all inclusion and no exclusion criteria, and be willing to comply with all protocol testing and follow-up.
Who may be able to join
- Must be at least 18 years of age;
- Able and willing to provide written informed consent;
- Eligible for minimally invasive or endovascular treatment in the peripheral vasculature;
- Not participating in an investigational study involving the peripheral vasculature.
Who cannot join
- Disease targeted for treatment in the coronary vasculature or intra-cerebral vasculature;
- Vasculature that cannot accommodate the Magellan™ Robotic Catheter or required accessories;
- The required delivery of therapeutic device(s) through the Magellan Robotic Catheter in which the diameter for the therapeutic device(s) is/are incompatible with the Magellan Robotic Catheter;
- An endovascular approach to the treatment of peripheral vasculature disease is contraindicated.
- Patients who are prisoners.
- Patients who are mentally incapacitated, e.g., comatose, unresponsive, cannot provide informed consent, or deemed unreliable or unstable by the investigator.
- Patients with a cognitive impairment.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States5 sites
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Miami Valley Hospital
Dayton, Ohio, 45409
The Methodist Hospital
Houston, Texas, 77030
Keck Medical Center of USC
Los Angeles, California, 90033
Miami Cardiac & Vascular Institute
Miami, Florida, 33176
About this study
Official title: The Robotic Vascular and Endovascular Registry (ROVER)
The purpose of the registry is to gather both retrospective and prospective case data on the use of the commercially available Magellan Robotic System and Magellan Robotic Catheters in accordance with the approved intended use. For prospective cases, follow-up patient data will be collected at 14 days (± 5 days) post procedure to assess treatment success, primary patency of intended targeted vessel region, and adverse events.
The data will be analyzed for medical education, societal presentation, and/or publication by the investigators.
Over the next 2+ years, physicians who meet the selection criteria will be invited to participate in the registry.
Read the detailed description
The objectives of the study are to allow the physician to use the commercially available Magellan Robotic System and Magellan Robotic Catheters to navigate to the treatment targets in the peripheral vasculature to:
- Determine the number of endovascular procedures consecutively performed with the Magellan Robotic System to navigate to treatment targets in the peripheral vasculature and,
- Achieve stable and efficient system preparation and set-up times, navigation and cannulation times of target vessels during endovascular procedures, and placement of therapeutic equipment used to perform endovascular procedures.
- Achieve stable and reduced fluoroscopy time during the endovascular procedures.
- Determine the number of cases required to reach a "steady state," reduction or predictable time in conducting peripheral interventional procedures using descriptive (means, ranges) statistics to analyze the data.
Design
This is a prospective and retrospective, multi-center, single arm, non-blinded, sequentially enrolling data collection activity (for which Hansen Medical is providing funding). Only patients scheduled to undergo endovascular procedures using the Magellan Robotic System will be approached for enrollment.
Methods
Registry procedures will be conducted in accordance with the labeled indication for use of the Magellan™ Robotic System.
Prior to the physician participating in the registry and prior to subject enrollment, all participating physicians will be required to complete Hansen Medical's Magellan Robotic System training.
Participating registry sites must have a commercially available Magellan Robotic System for the treatment of patients.
Data Management
Participating sites will be assigned a specific site numeric identification code by the registry sponsor.
The information collected into the registry will be data related to the procedure in which the Magellan System was used or planned to be used and may include patient follow-up data, minimally 14 days(± 5 days)post procedure but also may include 30 day follow-up to assess for the resolution of a procedural or post procedure adverse event.
The database will be a repository for the collected registry data and the data will be made available (in extractable format) to the physician participants.
Adverse Events
The data submitted will be reviewed on a regular basis for safety issues and complaints.
Adverse events and/or complaints deemed reportable will be submitted to the appropriate regulatory agency/agencies by Hansen Medical, Inc.
- Conditions
- Peripheral Vascular Disease
- Keywords
- Vascular disease, Minimally invasive treatment, Endovascular treatment, Magellan, Robotic
- Medical subject headings
- Peripheral Vascular Diseases, Vascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
Consistent manual delivery of therapeutic devices to the target vessel area in the peripheral vasculature by the physician.
Measured: 14 days post procedure
Safety
Incidence and description of device-related (Magellan Robotic System only) adverse events through the follow up period.
Measured: 14 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 348 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Hansen Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Bismuth, MD, Principal investigator, The Methodist Hospital Research InstituteBrenda Cayme, RN, BSN, Study director, Hansen Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984437
- Sponsor's protocol ID
- HMP020
- Acronym
- ROVER
- Status last verified
- Jul 2016
- First submitted
- 8 Nov 2013
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Robotic Vascular and Endovascular Registry (ROVER)
- ClinicalTrials.gov ID
- NCT01984437
- Acronym / sponsor ID
- ROVER / HMP020
- Conditions
- Peripheral Vascular Disease
- Keywords
- Vascular disease, Minimally invasive treatment, Endovascular treatment, Magellan, Robotic
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Hansen MedicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
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 the registry is to gather both retrospective and prospective case data on the use of the commercially available Magellan Robotic System and Magellan Robotic Catheters in accordance with the approved intended use. For prospective cases, follow-up patient data will be collected at 14 days (± 5 days) post procedure to assess treatment success, primary patency of intended targeted vessel region, and adverse events.
The data will be analyzed for medical education, societal presentation, and/or publication by the investigators.
Over the next 2+ years, physicians who meet the selection criteria will be invited to participate in the registry.
Detailed description
The objectives of the study are to allow the physician to use the commercially available Magellan Robotic System and Magellan Robotic Catheters to navigate to the treatment targets in the peripheral vasculature to:
- Determine the number of endovascular procedures consecutively performed with the Magellan Robotic System to navigate to treatment targets in the peripheral vasculature and,
- Achieve stable and efficient system preparation and set-up times, navigation and cannulation times of target vessels during endovascular procedures, and placement of therapeutic equipment used to perform endovascular procedures.
- Achieve stable and reduced fluoroscopy time during the endovascular procedures.
- Determine the number of cases required to reach a "steady state," reduction or predictable time in conducting peripheral interventional procedures using descriptive (means, ranges) statistics to analyze the data.
Design
This is a prospective and retrospective, multi-center, single arm, non-blinded, sequentially enrolling data collection activity (for which Hansen Medical is providing funding). Only patients scheduled to undergo endovascular procedures using the Magellan Robotic System will be approached for enrollment.
Methods
Registry procedures will be conducted in accordance with the labeled indication for use of the Magellan™ Robotic System.
Prior to the physician participating in the registry and prior to subject enrollment, all participating physicians will be required to complete Hansen Medical's Magellan Robotic System training.
Participating registry sites must have a commercially available Magellan Robotic System for the treatment of patients.
Data Management
Participating sites will be assigned a specific site numeric identification code by the registry sponsor.
The information collected into the registry will be data related to the procedure in which the Magellan System was used or planned to be used and may include patient follow-up data, minimally 14 days(± 5 days)post procedure but also may include 30 day follow-up to assess for the resolution of a procedural or post procedure adverse event.
The database will be a repository for the collected registry data and the data will be made available (in extractable format) to the physician participants.
Adverse Events
The data submitted will be reviewed on a regular basis for safety issues and complaints.
Adverse events and/or complaints deemed reportable will be submitted to the appropriate regulatory agency/agencies by Hansen Medical, Inc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects must be diagnosed with vascular disease in the peripheral vasculature, meet all inclusion and no exclusion criteria, and be willing to comply with all protocol testing and follow-up.
Key inclusion criteria (4 listed)
- Must be at least 18 years of age;
- Able and willing to provide written informed consent;
- Eligible for minimally invasive or endovascular treatment in the peripheral vasculature;
- Not participating in an investigational study involving the peripheral vasculature.
Key exclusion criteria (7 listed)
- Disease targeted for treatment in the coronary vasculature or intra-cerebral vasculature;
- Vasculature that cannot accommodate the Magellan™ Robotic Catheter or required accessories;
- The required delivery of therapeutic device(s) through the Magellan Robotic Catheter in which the diameter for the therapeutic device(s) is/are incompatible with the Magellan Robotic Catheter;
- An endovascular approach to the treatment of peripheral vasculature disease is contraindicated.
- Patients who are prisoners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness
Time frame: 14 days post procedure
Consistent manual delivery of therapeutic devices to the target vessel area in the peripheral vasculature by the physician.
Safety
Time frame: 14 days post procedure
Incidence and description of device-related (Magellan Robotic System only) adverse events through the follow up period.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
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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.
Jean Bismuth, MD principal investigator
The Methodist Hospital Research Institute
Brenda Cayme, RN, BSN study director
Hansen Medical, Inc.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Disease, run by Hansen Medical at 7 sites in 3 countries.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, France, Germany. 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?
The study was stopped early. Results are not available in the source record.
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?
Effectiveness (time frame: 14 days post 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?
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 1 Mar 2018.