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NCT Number: NCT06782100

MRI Guided Management of Occlusive Peripheral Arterial Disease

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.

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Key information

Conditions

Peripheral Vascular Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Please see attached study protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. Patient outcome measures

    Time frame: Intraprocedural

    • Plaque-crossing time (seconds),
    • successful target lesion revascularization (yes or no)
    • use of adjunct devices beyond plain balloon angioplasty (record name of device[s])
    • injury/dissection of vessel requiring stent (record event title e.g. dissection)
    • plaque embolization (yes/no)
    • number and stiffness of wires and catheters used (record device names)
    • subintimal crossing (yes/no)
    • outcomes after antegrade/retrograde access (successful/unsuccessful)

  2. Amputation Arm Outcomes

    Time frame: From Experiment and Histologicla Examination

    • Minimal inflation pressure
    • mean luminal gain percentage based on IVUS
    • severity of dissections using iDissection classification and
    • endothelial injury

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Trisha Roy, MD, PhD

CONTACT

[email protected]

713-441-5200

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jan 17, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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