Peripheral Arterial DiseaseMDG-PeriphNCT03585387
Cardiac Positioning System in Peripheral Angioplasty Procedure.
An observational study of Peripheral Arterial Disease, run by Abbott Medical Devices at 1 site in Canada.
Trial summary
This clinical investigation is intended to evaluate the ability of a magnetic cardiac positioning system to decrease medical radiation exposure on a peripheral angioplasty procedure in patients with a peripheral artery stenosis. 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?
- Navigation
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 27 Feb 2019to 9 Jun 2020
- 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: This is a prospective single-center, acute data collection study in 12 patients suffering from a peripheral arterial disease with an indication for an angioplasty procedure.
Who may be able to join
- At least 18 years of age;
- Scheduled for clinically indicated or contemplated percutaneous transluminal angioplasty or stenting of an peripheral artery;
- Able to provide informed consent for study participation and willing and able to comply with the Clinical Investigational Plan described evaluation.
Who cannot join
- Pregnant women or women planning to be pregnant during the study.
- Patients currently participating in another clinical study
- Patients with a thrombophilia
- Patients with critical limb ischemia
- Patients with unstable clinical condition or conditions limiting life expectancy that, in the opinion of the Study Investigator, excludes the participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluoroscopy vs Cardiac Positioning System Comparison to Assist the Navigation and Positioning of a Balloon Catheter in a Peripheral Artery During an Angioplasty Procedure
This clinical investigation is intended to evaluate the ability of a magnetic cardiac positioning system to decrease medical radiation exposure on a peripheral angioplasty procedure in patients with a peripheral artery stenosis.
Read the detailed description
The present study aims at addressing the fluoroscopy exposure time concern among physicians by proposing a new methodology that capitalizes on the cardiac positioning system (CPS) to reach near-zero fluoroscopy time for interventional cardiologists.
Intracoronary navigation of balloon catheter toward an anatomical landmark will be done with two navigation method:
- Fluoroscopy alone
- Fluoroscopy + CPS combination.
The order of the navigation method (method 1 then method 2 or vice versa) will be determine arbitrarily determined for each subject.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Navigation
- 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.
NavigationProcedure or surgery
Navigation of a balloon catheter using two navigation methods (1-Fluoroscopy only; 2- Fluoroscopy + CPS).
| Study group | Role | What they receive |
|---|---|---|
| Main | Each subject in this group will be its own control for the two navigation methods. Receives: Procedure: Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of radiation
Medical radiation exposure for each balloon positioning
Measured: Changes from time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over 2 hours.
Secondary outcomes (6)
Time duration
Procedure time for each balloon catheter positioning.
Measured: From time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over a 2 hours time frame.
Dose area product (DAP)
Total amount of radiation delivered to the patient
Measured: DAP change from when balloon leaves the sheath to final alignment with anatomical landmark assessed every 15 minutes over a 2 hours time frame.
Success or no-success in balloon navigation
Physician assessment of balloon navigation and center alignment with an anatomical landmark.
Measured: Determined every 15 minutes over a 2 hours time frame.
Volume of contrast required to get the balloon to the anatomical landmark.
Volume used
Measured: Change of volume of contrast from when balloon leaves the sheath to final alignment with anatomical landmark assessed every 15 minutes over a 2 hours time frame.
Distance measurements
Distance between the center of balloon aligned with anatomical landmark and the two radiopaque balloon markers.
Measured: At end of procedure
Number of adverse events.
Adverse event count
Measured: At end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start27 Feb 2019
- Primary completion10 May 2020
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585387
- Sponsor's protocol ID
- 10252
- Acronym
- MDG-Periph
- Status last verified
- Jul 2019
- First submitted
- 19 Jun 2018
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroscopy vs Cardiac Positioning System Comparison to Assist the Navigation and Positioning of a Balloon Catheter in a Peripheral Artery During an Angioplasty Procedure
- ClinicalTrials.gov ID
- NCT03585387
- Acronym / sponsor ID
- MDG-Periph / 10252
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 13 Jul 2018 (actual)
- 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.
This clinical investigation is intended to evaluate the ability of a magnetic cardiac positioning system to decrease medical radiation exposure on a peripheral angioplasty procedure in patients with a peripheral artery stenosis.
Detailed description
The present study aims at addressing the fluoroscopy exposure time concern among physicians by proposing a new methodology that capitalizes on the cardiac positioning system (CPS) to reach near-zero fluoroscopy time for interventional cardiologists.
Intracoronary navigation of balloon catheter toward an anatomical landmark will be done with two navigation method:
- Fluoroscopy alone
- Fluoroscopy + CPS combination.
The order of the navigation method (method 1 then method 2 or vice versa) will be determine arbitrarily determined for each subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main | – | Procedure: NavigationEach subject in this group will be its own control for the two navigation methods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective single-center, acute data collection study in 12 patients suffering from a peripheral arterial disease with an indication for an angioplasty procedure.
Key inclusion criteria (3 listed)
- At least 18 years of age;
- Scheduled for clinically indicated or contemplated percutaneous transluminal angioplasty or stenting of an peripheral artery;
- Able to provide informed consent for study participation and willing and able to comply with the Clinical Investigational Plan described evaluation.
Key exclusion criteria (5 listed)
- Pregnant women or women planning to be pregnant during the study.
- Patients currently participating in another clinical study
- Patients with a thrombophilia
- Patients with critical limb ischemia
- Patients with unstable clinical condition or conditions limiting life expectancy that, in the opinion of the Study Investigator, excludes the participation.
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 |
|---|---|---|
| NavigationNavigation of a balloon catheter using two navigation methods (1-Fluoroscopy only; 2- Fluoroscopy + CPS). | Procedure or surgery | Main |
Primary outcome
Time of radiation
Time frame: Changes from time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over 2 hours.
Medical radiation exposure for each balloon positioning
6 secondary outcomes
Time duration
Time frame: From time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over a 2 hours time frame.
Dose area product (DAP)
Time frame: DAP change from when balloon leaves the sheath to final alignment with anatomical landmark assessed every 15 minutes over a 2 hours time frame.
Success or no-success in balloon navigation
Time frame: Determined every 15 minutes over a 2 hours time frame.
Volume of contrast required to get the balloon to the anatomical landmark.
Time frame: Change of volume of contrast from when balloon leaves the sheath to final alignment with anatomical landmark assessed every 15 minutes over a 2 hours time frame.
Distance measurements
Time frame: At end of procedure
Number of adverse events.
Time frame: At end of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Abbott Medical Devices at 1 site in Canada.
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 3 inclusion and 5 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 11 Jun 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time of radiation (time frame: Changes from time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over 2 hours.). 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 11 Jun 2020.