Cardiovascular DiseasesNCT02725307
Non-invasive Peri- and Postoperative Monitoring of Femoral Artery Balloon Angioplasty
An observational study of Cardiovascular Diseases, run by Tampere University Hospital at 1 site in Finland.
Trial summary
This study evaluates a novel noninvasive method to dynamically monitor the effect of percutaneous transluminal angioplasty on arterial pulse wave Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Noninvasive pulse wave analysis sensor, ECG-sensor
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2016to May 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Volunteer patients with diagnosed peripheral atherosclerotic disease referred for femoral artery percutaneous transluminal angioplastu.
Who may be able to join
- The patient has been clinically examined at policlinic of vascular surgery
- The patient has undergone measurement of ankle-brachial index (ABI) and toe-brachial index (TBI) at policlinic of vascular surgery and exhibits abnormal ABI<0.9 or ABI>1.3
- The patient is considered to have an indication for vascular procedure (critical limb ischemia, intermittent claudication)
- The patient has been examined with magnetic resonance imaging (MRA)
- The patient has been considered a candidate for superficial femoral artery percutaneous transluminal balloon angioplasty (PTA) and/or stenting
Who cannot join
- Pacemaker
- Measurement disturbs or risks the subject's treatment process
- Withdrawal:
- Emergency cases
- By subject's denial
- Inability to detect signals -
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates a novel noninvasive method to dynamically monitor the effect of percutaneous transluminal angioplasty on arterial pulse wave
Read the detailed description
Patients with stenosis of superficial femoral artery referred for percutaneous transluminal angioplasty are monitored before, during and after the procedure and pulse wave analysis is conducted.
- Conditions
- Cardiovascular Diseases
- Being tested
- Noninvasive pulse wave analysis sensor, ECG-sensor
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive pulse wave analysis sensor, ECG-sensorDevice
Noninvasive pulse wave sensors and ECG-sensors are attached
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave change from baseline during PTA
Measured: 1 hour
Secondary outcomes (1)
Pulse wave characteristics after PTA
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University of Technology, Tampere University
- Responsible party
- Principal investigator, Niku Oksala, Tampere University Hospital
- Investigators
- Niku Oksala, Assoc. Prof., Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725307
- Sponsor's protocol ID
- R15107
- Status last verified
- May 2017
- First submitted
- 16 Mar 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Peri- and Postoperative Monitoring of Femoral Artery Balloon Angioplasty
- ClinicalTrials.gov ID
- NCT02725307
- Acronym / sponsor ID
- R15107
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University of Technology, Tampere University
- Study start
- Mar 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 31 Mar 2016 (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.
This study evaluates a novel noninvasive method to dynamically monitor the effect of percutaneous transluminal angioplasty on arterial pulse wave
Detailed description
Patients with stenosis of superficial femoral artery referred for percutaneous transluminal angioplasty are monitored before, during and after the procedure and pulse wave analysis is conducted.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Volunteer patients with diagnosed peripheral atherosclerotic disease referred for femoral artery percutaneous transluminal angioplastu.
Key inclusion criteria (5 listed)
- The patient has been clinically examined at policlinic of vascular surgery
- The patient has undergone measurement of ankle-brachial index (ABI) and toe-brachial index (TBI) at policlinic of vascular surgery and exhibits abnormal ABI<0.9 or ABI>1.3
- The patient is considered to have an indication for vascular procedure (critical limb ischemia, intermittent claudication)
- The patient has been examined with magnetic resonance imaging (MRA)
- The patient has been considered a candidate for superficial femoral artery percutaneous transluminal balloon angioplasty (PTA) and/or stenting
Key exclusion criteria (6 listed)
- Pacemaker
- Measurement disturbs or risks the subject's treatment process
- Emergency cases
- By subject's denial
- Inability to detect signals -
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 |
|---|---|---|
| Noninvasive pulse wave analysis sensor, ECG-sensorNoninvasive pulse wave sensors and ECG-sensors are attached | Device | – |
Primary outcome
Pulse wave change from baseline during PTA
Time frame: 1 hour
1 secondary outcome
Pulse wave characteristics after PTA
Time frame: 30 days
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 4 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Niku Oksala, Assoc. Prof. principal investigator
Tampere University
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 Cardiovascular Diseases, run by Tampere University Hospital at 1 site in Finland.
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 6 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 May 2017. 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 Finland. 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?
Pulse wave change from baseline during PTA (time frame: 1 hour). 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 May 2017.