Percutaneous Transluminal AngioplastyNCT03898869
Measurement of Revascularization Effect Using NIRS in BTK Arteries
An observational study of Percutaneous Transluminal Angioplasty and Wound Heal, run by Vilnius University at 1 site in Lithuania.
Trial summary
Patient with occluded below the knee arteries and chronic limb ischemia Rutherford class V-VI are enrolled. During endovascular recanalisation procedure changes in tissue oxygen amount is recorded using near infrared spectroscopy (NIRS). Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Percutaneous Transluminal Angioplasty, Wound Heal, Ischemic Feet
- What is being tested?
- Intraoperative NIRS monitoring
- How many people
- 30 participants
- Where
- 1 siteLithuania
- Study dates
- 29 Mar 2019to Jan 2022
- How long will I take part?
- 12 Months
- 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 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All-comers meeting eligibility criteria in VMK hospital, Vascular surgery department.
Who may be able to join
- Critical limb ischemia Rutherford V-VI
- At least one artery below the knee is planned to revascularize
Who cannot join
- Blood oxygen saturation below 85% because of any comorbidities
- Life expectancy less than 12 months
- Unavoidable amputation above ankle
- Skin diseases preventing the use of NIRS
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Vilniaus Miesto Klinikinė hospital
Vilnius, LT-10207
Tomas Baltrūnas
About this study
Official title: Measurement of Revascularization Effect Using Near Infrared Spectroscopy in Below the Knee Arteries
Patient with occluded below the knee arteries and chronic limb ischemia Rutherford class V-VI are enrolled.
During endovascular recanalisation procedure changes in tissue oxygen amount is recorded using near infrared spectroscopy (NIRS).
Primary hypothesis - NIRS can be used to determine sufficient amount of blood reaching the ulcered ishemic area.
Secondary hypothesis - NIRS can be useful in detecting early recoil after BTK recanalisation.
- Being tested
- Intraoperative NIRS monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative NIRS monitoringDiagnostic test
Near infrared spectroscopy non invasively used to register changes in tissue oxygen amount during endovascular revascularization
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in oxygen amount sufficient for wound healing
Measured: 12 months
Secondary outcomes (1)
Detection of early recoil after BTK revascularization
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start29 Mar 2019
- Primary completionJan 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Transluminal AngioplastyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomas Baltrūnas, Vilnius University
- Investigators
- Tomas Baltrūnas, Principal investigator, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898869
- Sponsor's protocol ID
- BTK-01
- Status last verified
- Mar 2019
- First submitted
- 29 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Revascularization Effect Using Near Infrared Spectroscopy in Below the Knee Arteries
- ClinicalTrials.gov ID
- NCT03898869
- Acronym / sponsor ID
- BTK-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 2 Apr 2019 (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.
Patient with occluded below the knee arteries and chronic limb ischemia Rutherford class V-VI are enrolled.
During endovascular recanalisation procedure changes in tissue oxygen amount is recorded using near infrared spectroscopy (NIRS).
Primary hypothesis - NIRS can be used to determine sufficient amount of blood reaching the ulcered ishemic area.
Secondary hypothesis - NIRS can be useful in detecting early recoil after BTK recanalisation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comers meeting eligibility criteria in VMK hospital, Vascular surgery department.
Key inclusion criteria (2 listed)
- Critical limb ischemia Rutherford V-VI
- At least one artery below the knee is planned to revascularize
Key exclusion criteria (4 listed)
- Blood oxygen saturation below 85% because of any comorbidities
- Life expectancy less than 12 months
- Unavoidable amputation above ankle
- Skin diseases preventing the use of NIRS
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 |
|---|---|---|
| Intraoperative NIRS monitoringNear infrared spectroscopy non invasively used to register changes in tissue oxygen amount during endovascular revascularization | Diagnostic test | – |
Primary outcome
Increase in oxygen amount sufficient for wound healing
Time frame: 12 months
1 secondary outcome
Detection of early recoil after BTK revascularization
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
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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.
Tomas Baltrūnas principal investigator
Vilnius 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 Percutaneous Transluminal Angioplasty and Wound Heal, run by Vilnius University at 1 site in Lithuania.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Apr 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 Lithuania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomas Baltrūnas (+37052344519, tomas.baltrunas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in oxygen amount sufficient for wound healing (time frame: 12 months). 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 2 Apr 2019.