MRI Guided Management of Occlusive Peripheral Arterial Disease
The Methodist Hospital Research Institute
175 participants
Jul 1, 2024
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- i. All patients will be ≥ 18 years old with PAD (Rutherford Category 4, 5, 6)
- 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 Criteria2
- i. Rutherford category 0, 1, 2, 3 of target limb, Failure or refusal to provide written informed consent, MRI Contraindications
- ii. Aim 2 only - Chronic total occlusions
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06782100