Peripheral Arterial DiseaseNCT06525415
Foot Perfusion by Dynamic Contrast Enhanced MRI in Patients With Peripheral Artery Disease
An observational study of Peripheral Arterial Disease and Perfusion, run by Fudan University.
Trial summary
We investigate the peri-operative foot perfusion through dynamic contrast enhanced MRI in patients with peripheral artery disease Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease, Perfusion
- What is being tested?
- DCE MRI
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 30 Nov 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with peripheral artery disease, who had a successful endovascular treatment and completed both pre- and post-operative MRI workups
Who may be able to join
- 18 to 80 years old;
- PAD patients with Fontaine grade II-IV or Rutherford grade 2-6 and underwent a successful revascularization;
- Patients completed both pre- and post-operative MRI workups;
- Patients signed the informed consent form and be able to complete the clinical follow-up for 1 months.
Who cannot join
- Patients has participated in other clinical studies;
- Patients with Heart failure (NYHA III/IV)/right to left shunt heart disease/ severe aortic and mitral insufficiency/acute coronary syndrome/malignant arrhythmia/severe pulmonary hypertension (pulmonary artery pressure at least 90 mmHg)/moderate to severe renal insufficiency (creatinine clearance rate<60 ml/min)
- Any allergic constitution;
- Pregnancy and childbirth;
- Life expectancy<12 months.
About this study
We investigate the peri-operative foot perfusion through dynamic contrast enhanced MRI in patients with peripheral artery disease
- Conditions
- Peripheral Arterial Disease, Perfusion
- Being tested
- DCE MRI
- 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.
DCE MRIDiagnostic test
the recruited patients should complete pre- and post-operative DCE MRI workshops
| Study group | Role | What they receive |
|---|---|---|
| PAD group | patients of peripheral artery disease who underwent endovascular treatment Receives: Diagnostic Test: DCE MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative perfusion parameters
preoperative perfusion parameters by dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI)
Measured: Between Aug.1 2024 and OCT.31 2024
Secondary outcomes (3)
ankle brachial index
Measured: Between Aug.1 2024 and OCT.31 2024
clinical success
Measured: Between Aug.1 2024 and NOV.30 2024
survival
Measured: Between Aug.1 2024 and NOV.30 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525415
- Sponsor's protocol ID
- 2024ZW001
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou K, Chen C, Du S, Zhang J, Li S, Zhu T, Dong Y, Zhang W. Foot dynamic contrast-enhanced MRI for assessing microcirculatory changes after endovascular therapy in peripheral artery disease: A prospective pilot study. Magn Reson Imaging. 2026 Nov;133:110740. doi: 10.1016/j.mri.2026.110740. Epub 2026 Jul 2.
PubMed 42392285
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Perfusion by Dynamic Contrast Enhanced MRI in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT06525415
- Acronym / sponsor ID
- 2024ZW001
- Conditions
- Peripheral Arterial Disease, Perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 29 Jul 2024 (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.
We investigate the peri-operative foot perfusion through dynamic contrast enhanced MRI in patients with peripheral artery disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAD group | – | Diagnostic Test: DCE MRIpatients of peripheral artery disease who underwent endovascular treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with peripheral artery disease, who had a successful endovascular treatment and completed both pre- and post-operative MRI workups
Key inclusion criteria (4 listed)
- 18 to 80 years old;
- PAD patients with Fontaine grade II-IV or Rutherford grade 2-6 and underwent a successful revascularization;
- Patients completed both pre- and post-operative MRI workups;
- Patients signed the informed consent form and be able to complete the clinical follow-up for 1 months.
Key exclusion criteria (5 listed)
- Patients has participated in other clinical studies;
- Patients with Heart failure (NYHA III/IV)/right to left shunt heart disease/ severe aortic and mitral insufficiency/acute coronary syndrome/malignant arrhythmia/severe pulmonary hypertension (pulmonary artery pressure at least 90 mmHg)/moderate to severe renal insufficiency (creatinine clearance rate<60 ml/min)
- Any allergic constitution;
- Pregnancy and childbirth;
- Life expectancy<12 months.
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 |
|---|---|---|
| DCE MRIthe recruited patients should complete pre- and post-operative DCE MRI workshops | Diagnostic test | PAD group |
Primary outcome
preoperative perfusion parameters
Time frame: Between Aug.1 2024 and OCT.31 2024
preoperative perfusion parameters by dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI)
3 secondary outcomes
ankle brachial index
Time frame: Between Aug.1 2024 and OCT.31 2024
clinical success
Time frame: Between Aug.1 2024 and NOV.30 2024
survival
Time frame: Between Aug.1 2024 and NOV.30 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Derived from this study: PubMed 42392285Zhou K, Chen C, Du S, Zhang J, Li S, Zhu T, Dong Y, Zhang W. Foot dynamic contrast-enhanced MRI for assessing microcirculatory changes after endovascular therapy in peripheral artery disease: A prospective pilot study. Magn Reson Imaging. 2026 Nov;133:110740. doi: 10.1016/j.mri.2026.110740. Epub 2026 Jul 2.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Perfusion, run by Fudan University.
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 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: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
preoperative perfusion parameters (time frame: Between Aug.1 2024 and OCT.31 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06525415, which also lists 1 linked publication.
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 29 Jul 2024.