MRI Guided Management of Occlusive Peripheral Arterial Disease

The Methodist Hospital Research Institute175 enrolled

Overview

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.

Please see attached study protocol.

Study Type

OBSERVATIONAL

Enrollment

175

Conditions

Peripheral Vascular Diseases

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

Patient primary Outcome

PVI failure due to inability to cross the target plaque with a guidewire.

Time frame: Intraprocedural - the outcome is at the time of the procedure, it is not a follow up outcome.

Amputation Arm Outcome

Presence of dissections on histology (number of dissections i.e. count, idissection score)

Time frame: From Experiment and detected during Histological Evaluation (there is no timeframe from this as it is after the experiment on histological analysis)

Secondary Outcomes

Patient outcome measures

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)

Time frame: Intraprocedural

Amputation Arm Outcomes

1. Minimal inflation pressure 2. mean luminal gain percentage based on IVUS 3. severity of dissections using iDissection classification and 4. endothelial injury

Time frame: From Experiment and Histologicla Examination

Patient Outcome Measure

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)