NCT06782100Recruiting

MRI Guided Management of Occlusive Peripheral Arterial Disease

The Methodist Hospital Research Institute

Start Date

7/1/2024

Completion Date

6/1/2029

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.

Detailed Description

Please see attached study protocol.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Peripheral Vascular Diseases

Locations

Houston Methodist Hospital

Houston, Texas 77030

United States