Recruiting

MRI Guided Management

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06782100

Conditions

Peripheral Vascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Peripheral Vascular Diseases

Study ID

NCT06782100

Start date

Jul 1, 2024

Status verified date

Mar, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

175 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

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. ]
  • Amputation Arm Outcome [ Time Frame: From Experiment and detected during Histological Evaluation (there is no timeframe from this as it is after the experiment on histological analysis) ]

Central Contacts and Locations

Central contacts

Trisha Roy, MD, PhD

713-441-5200troy@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Trisha Roy, MD, PhD

713-441-5200troy@houstonmethodist.org

Janak Lamichhane, MBBS, MBA

346- 238-2291jlamichhane@houstonmethodist.org

Principal Investigator:

Trisha Roy, MD, PhD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • MRI Guided Management of Occlusive Peripheral Arterial Disease
  • PAD
  • Peripheral Vascular Disease
  • PVI
  • MRI
  • MRA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-03-19.