Clinical trial NCT06782100: MRI Guided Management of Occlusive Peripheral Arterial Disease
Official title: MRI Guided Management of Occlusive Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Vascular Diseases
Keywords: MRI Guided Management of Occlusive Peripheral Arterial Disease
PAD
Peripheral Vascular Disease
PVI
MRI
MRA
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-01-17
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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: 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

Primary outcomes:
measure: Patient primary Outcome
timeFrame: Intraprocedural - the outcome is at the time of the procedure, it is not a follow up outcome.
measure: Amputation Arm Outcome
timeFrame: From Experiment and detected during Histological Evaluation (there is no timeframe from this as it is after the experiment on histological analysis)
Secondary outcomes:
measure: Patient outcome measures
timeFrame: Intraprocedural
measure: Amputation Arm Outcomes
timeFrame: From Experiment and Histologicla Examination
measure: Patient Outcome Measure
timeFrame: Intraprocedural
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
References:
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