MRI Guided Management of Occlusive Peripheral Arterial Disease

March 16, 2026 updated by: Triisha Roy, The Methodist Hospital Research Institute

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Please see attached study protocol.

Study Type

Observational

Enrollment (Estimated)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient primary Outcome
Time Frame: Intraprocedural - the outcome is at the time of the procedure, it is not a follow up outcome.
PVI failure due to inability to cross the target plaque with a guidewire.
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)
Presence of dissections on histology (number of dissections i.e. count, idissection score)
From Experiment and detected during Histological Evaluation (there is no timeframe from this as it is after the experiment on histological analysis)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient outcome measures
Time Frame: Intraprocedural
  1. Plaque-crossing time (seconds),
  2. successful target lesion revascularization (yes or no)
  3. use of adjunct devices beyond plain balloon angioplasty (record name of device[s])
  4. injury/dissection of vessel requiring stent (record event title e.g. dissection)
  5. plaque embolization (yes/no)
  6. number and stiffness of wires and catheters used (record device names)
  7. subintimal crossing (yes/no)
  8. outcomes after antegrade/retrograde access (successful/unsuccessful)
Intraprocedural
Amputation Arm Outcomes
Time Frame: From Experiment and Histologicla Examination
  1. Minimal inflation pressure
  2. mean luminal gain percentage based on IVUS
  3. severity of dissections using iDissection classification and
  4. endothelial injury
From Experiment and Histologicla Examination
Patient Outcome Measure
Time Frame: Intraprocedural
Hypothesis: Women will have less MRI-defined hard lesions and plaques that are easier to cross Comparison Groups: Women vs. Men Primary Outcome: PVI failure due to inability to cross the target plaque with a guidewire (record number of hard lesions i.e. count, comparing men and women)
Intraprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Methodist Hospital Research Institute

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00027258
  • R01HL174587 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Based on ethical and legal considerations, only the following data produced in the course of the project will be preserved and shared on a data repository platform: MRI, angiography, Cone Beam CT, and histology data.The final dataset will include self-reported demographic data. We will share de-identified individualparticipant level (IPD) data. Appropriate measures such as assigning a random code to each participant will be used for data de-identification and sharing, and informed consent forms will reflect those plans.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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