MRI Guided Management of Occlusive Peripheral Arterial Disease

Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how to better manage peripheral arterial disease (PAD), a condition where blood flow to the legs is reduced due to plaque build-up in the arteries. The goal is to identify which specific plaque lesions are hard to treat and to test different medical devices that might cause less damage to the blood vessels during treatment. Patients who participate will first have an MRI scan to examine the plaque in their arteries before any treatment, allowing doctors to predict how difficult the procedure might be. Additionally, patients who need a leg amputation due to PAD will have their limbs examined in a similar way to see how different devices affect the blood vessels.

To be eligible for this study, participants must be at least 40 years old and have more advanced stages of PAD. They should have at least one affected area below the knee with significant blockage. Participants can expect to undergo an MRI scan, and those in the second part of the study will also have their limbs tested with two different devices to see how they perform. This research aims to improve treatment options and outcomes for patients with peripheral arterial disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• A. General Inclusion Criteria:
• • i. All patients will be ≥ 40 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