Automatic Classification of Magnetic Resonance Histology of Peripheral Arterial Chronic Total Occlusions Using a Variational Autoencoder: A Feasibility Study.
Judit Csore, Christof Karmonik, Kayla Wilhoit...
https://pubmed.ncbi.nlm.nih.gov/37296778Actively Recruiting
Age: 18Years +
All Genders
ID06782100
MRI Guided Management of Occlusive Peripheral Arterial Disease
Led by The Methodist Hospital Research Institute · Updated on 2026-03-19
175
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
T
The Methodist Hospital Research Institute
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying peripheral arterial disease (PAD) to identify which plaque lesions are impenetrable and to find out which devices cause the least injury to the vessel walls. This observational study includes patients undergoing percutaneous vascular intervention (PVI) and patients undergoing lower limb amputation due to PAD. The study aims to improve understanding of plaque types and their impact on treatment success. Participants in the study will undergo MRI scans before their planned PVI to assess the plaque and predict procedural difficulty. For patients undergoing lower limb amputation, the removed limbs will also receive MRI scans to assess plaques. The study compares two devices, plain balloon angioplasty (POBA) and orbital atherectomy, in amputated limbs to evaluate their effects on the vessel wall and device safety. Plaques are categorized into four types based on MRI-histology: concentric calcium, eccentric calcium, fibrous plaque, and soft plaques. During the study, 100 patients will have scans using a 3T MAGNETOM MRI scanner. Doctors performing the PVI will not see the MRI results and will treat patients according to standard care. Researchers will analyze which plaques predict procedural failures and the need for additional devices or approaches. Outcomes will be measured during the procedure and through histological evaluation of amputated limbs. The study lasts until June 2029 and involves detailed imaging and histological assessments to improve PAD management.
CONDITIONS
Brief Title
MRI Guided Management of Occlusive Peripheral Arterial Disease
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older with peripheral arterial disease at Rutherford category 4, 5, or 6
- At least one target lesion below the knee in native vessels
- Target lesion reference vessel diameter between 2.0 and 4.0 millimeters by visual estimate
- Target lesion with more than 50% stenosis by visual estimate
You will not qualify if you...
- Patients with Rutherford category 0, 1, 2, or 3 of the target limb
- Failure or refusal to provide written informed consent
- Contraindications to MRI
- For the amputation arm only: chronic total occlusions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo MRI scans using optimized sequences to characterize plaque types and score lesions before any treatment.
1 imaging visit (in-person)
Monitoring
Duration - Intraprocedural
Participants who undergo standard peripheral vascular interventions are observed to assess procedure outcomes without alteration to their treatment.
During the procedure
Trial Site Locations
Total: 1 location
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
T
Trisha Roy, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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