Peripheral Arterial DiseaseNCT05045365
Perfusion Assessment Using BOLD MRI and PBV in Endovascular Treatment of Peripheral Arterial Occlusive Disease
An observational study of Peripheral Arterial Disease and Tissue Perfusion, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Current assessment of lower limb ischemia cannot reflect the location and degree of ischemia. Tissue perfusion assessment was used in the diagnosis and treatment of lower limb ischemia in this project, and the quantitative evaluation of ischemia degree was realized by using its advantages of quantitative analysis and… Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Tissue Perfusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Jun 2023
- 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study was conducted in PAOD patients aged 35 to 80 years with clinical symptoms such as claudication, resting pain, or ulceration, who were intended for endovascular treatment. Computed tomographic angiography disclosed the occlusive lesion in their target lesion. Subject with complex infrapopliteal lesions was excluded in order to reduce the influence of other variables.
Who may be able to join
- Subject has been diagnosed as PAOD by symptom and imaging;
- Subject intends to take endovascular treatment in PUMCH;
- Subjects without heavy stenosis in infrapopliteal artery (stenosis<30%), or with short length lesion(length≤5cm, stenosis≥30%);
- Age > 35 and < 80;
- Subject has been informed the study and has signed informed consent;
Who cannot join
- Subject with MRI contraindications or allergic to iodinated contrast medium;
- Subject underwent intervention therapy or angioplasty in target vessel within the last 3 months;
- Subject after stent implantation in superficial femoral artery;
- Subject with severe heart dysfunction, renal dysfunction, or cancer;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Bao Liu, M.D., 010-69152502, liubao72@aliyun.com
About this study
Official title: A Prospective Study: Perfusion Assessment Using Blood Oxygen Level Dependent Functional Magnetic Resonance Angiographic Imaging and Parenchymal Blood Volume Imaging in Endovascular Treatment of Peripheral Arterial Occlusive Disease
Current assessment of lower limb ischemia cannot reflect the location and degree of ischemia. Tissue perfusion assessment was used in the diagnosis and treatment of lower limb ischemia in this project, and the quantitative evaluation of ischemia degree was realized by using its advantages of quantitative analysis and perfusion imaging.
- Conditions
- Peripheral Arterial Disease, Tissue Perfusion
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion of the index leg assessed by BOLD MRI before and after endovascular intervention.
BOLD evaluates perfusion noninvasively and can be used for long-term monitoring and postoperative follow-up. Improving the perfusion assessment will improve the evaluation system for endovascular treatment of PAOD.
Measured: 1 year
Perfusion of the index leg assessed by PBV before and after endovascular intervention.
PBV can evaluate intraoperative perfusion quantitatively in real time.
Measured: During operation
Secondary outcomes (1)
The relationship between perfusion and function of the lower limb in PAOD patients
The preoperative and postoperative motor functions of the patients were tested to analyze the functional impact of perfusion improvement.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Dec 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
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 Peking Union Medical College 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045365
- Sponsor's protocol ID
- LBXZ-2105
- Status last verified
- Sep 2021
- First submitted
- 2 Jun 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study: Perfusion Assessment Using Blood Oxygen Level Dependent Functional Magnetic Resonance Angiographic Imaging and Parenchymal Blood Volume Imaging in Endovascular Treatment of Peripheral Arterial Occlusive Disease
- ClinicalTrials.gov ID
- NCT05045365
- Acronym / sponsor ID
- LBXZ-2105
- Conditions
- Peripheral Arterial Disease, Tissue Perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 16 Sep 2021 (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.
Current assessment of lower limb ischemia cannot reflect the location and degree of ischemia. Tissue perfusion assessment was used in the diagnosis and treatment of lower limb ischemia in this project, and the quantitative evaluation of ischemia degree was realized by using its advantages of quantitative analysis and perfusion imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted in PAOD patients aged 35 to 80 years with clinical symptoms such as claudication, resting pain, or ulceration, who were intended for endovascular treatment. Computed tomographic angiography disclosed the occlusive lesion in their target lesion. Subject with complex infrapopliteal lesions was excluded in order to reduce the influence of other variables.
Key inclusion criteria (5 listed)
- Subject has been diagnosed as PAOD by symptom and imaging;
- Subject intends to take endovascular treatment in PUMCH;
- Subjects without heavy stenosis in infrapopliteal artery (stenosis<30%), or with short length lesion(length≤5cm, stenosis≥30%);
- Age > 35 and < 80;
- Subject has been informed the study and has signed informed consent;
Key exclusion criteria (4 listed)
- Subject with MRI contraindications or allergic to iodinated contrast medium;
- Subject underwent intervention therapy or angioplasty in target vessel within the last 3 months;
- Subject after stent implantation in superficial femoral artery;
- Subject with severe heart dysfunction, renal dysfunction, or cancer;
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
Perfusion of the index leg assessed by BOLD MRI before and after endovascular intervention.
Time frame: 1 year
BOLD evaluates perfusion noninvasively and can be used for long-term monitoring and postoperative follow-up. Improving the perfusion assessment will improve the evaluation system for endovascular treatment of PAOD.
Perfusion of the index leg assessed by PBV before and after endovascular intervention.
Time frame: During operation
PBV can evaluate intraoperative perfusion quantitatively in real time.
1 secondary outcome
The relationship between perfusion and function of the lower limb in PAOD patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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.
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 and Tissue Perfusion, run by Peking Union Medical College Hospital at 1 site in China.
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 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 16 Sep 2021. 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 China. 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 Bao Liu, M.D. (010-69152592, liubao72@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion of the index leg assessed by BOLD MRI before and after endovascular intervention. (time frame: 1 year). 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 16 Sep 2021.