MRI Guided Management of Occlusive Peripheral Arterial Disease

Conditions

• Peripheral Vascular Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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 Dates

Start date

Jul 1, 2024

Status verified

Mar 2026

Primary completion

Jul 1, 2028

Completion

Jun 30, 2029

Study Design

Enrollment

175 participants (estimated)

Arms

• Arm: Amputation Arm
  In an ex vivo human cadaveric model, post-PVI histopathologic analysis will be used to uncover the impact of plaque type on device safety (POBA versus atherectomy) and performance, facilitating evidence-based device selection to mitigate complications. Using a randomized approach, the investigator will compare plain balloon angioplasty to orbital atherectomy prior to angioplasty in amputated legs from PAD patients with plaques characterized into 4 categories based their MRI-histology: concentric calcium, eccentric calcium, fibrous plaque, and soft plaques (smooth muscle and thrombus).
• Arm: Revascularization Arm
  Patient Imaging Protocol: Scans will be performed on 100 patients enrolled into the study population using a 3T MAGNETOM scanner (Siemens) at the Houston Methodist Research Institute Translational Imaging Center. The investigator will use pre-operative images captured using the optimized MRI-histology sequences to score lesions. Physicians performing PVI will be blinded to the pre-operative MRI-histology images and anatomic scores and will make treatment decisions based on their standard of care. The investigator expect MRI-histology plaque scores predict which patients will have PVI failures due to untraversable plaque, and it may also foresee the potential need of adjunctive devices or alternative approaches for successful PVI

Primary Outcome Measure

Patient primary Outcome [ Time Frame: Intraprocedural - the outcome is at the time of the procedure, it is not a follow up outcome. ]

Central Contacts

• Trisha Roy, MD, PhD
  713-441-5200
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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