MRI Guided Management of Occlusive Peripheral Arterial Disease

Recruiting now

Conditions studied: Peripheral Vascular Diseases

In brief

The goal of this observational study is to identify which plaque lesions in patients with peripheral arterial disease are impenetrable and to determine which devices minimize vessel wall injury. Patients undergoing intervention will have an MRI scan prior to their planned percutaneous vascular intervention to assess the plaque and predict procedural difficulty. Patients undergoing lower limb amputation due to peripheral arterial disease will have their limbs included into a second arm of the study The limb will undergo an MRI scan to assess the plaque. The investigator will then test two different devices and assess the effects of these devices on the vessel wall.

Key facts

Study ID: NCT06782100
Run by: The Methodist Hospital Research Institute
People needed: 175
Starts: 2024-07-01
Expected to finish: 2029-06-01
Last updated by the study team: 2026-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Houston Methodist Hospital — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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