MRI scans could make leg artery procedures safer
NCT ID NCT06782100
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study uses MRI scans to look at plaque buildup in leg arteries of people with peripheral arterial disease. Researchers want to see which plaques are hard to cross with a guidewire and which devices cause the least damage to the vessel wall. The study includes patients undergoing artery procedures and those having leg amputations. It aims to improve how doctors plan and perform these treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors choose better devices and techniques for treating blocked leg arteries, potentially reducing complications.
- What could go wrong
- This is an observational study, not a treatment trial. It may not lead to direct patient benefits, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 175 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
For Revascularization Arm: Patients will be enrolled from Vascular surgical Care at Houston Methodist Hospital and undergoing lower limb PVI. For Amputation Arm: Patients undergoing Major lower limb amputation at Houston Methodist Hospital with PAD.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: A. General Inclusion Criteria: i. All patients will be ≥ 18 years old with PAD (Rutherford Category 4, 5, 6) B. Anatomic inclusion criteria: i. At least 1 target lesion below-the-knee in native vessels in one or both limbs ii. Target lesion reference vessel diameter between 2.0 - 4.0 mm by investigator visual estimate iii. Target lesion with \> 50% stenosis by investigator visual estimate Exclusion Criteria: A. General Exclusion Criteria: i. Rutherford category 0, 1, 2, 3 of target limb, Failure or refusal to provide written informed consent, MRI Contraindications B. Anatomic Exclusion Criteria: ii. Aim 2 only - Chronic total occlusions
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Houston Methodist Hospital
RECRUITINGHouston, Texas, 77030, United States
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