MRI Guided Management of Occlusive Peripheral Arterial Disease

Recruiting

• Conditions: Peripheral Vascular Diseases

• Registration Number: NCT06782100
• Lead Sponsor: The Methodist Hospital Research Institute

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.

Detailed Description

Please see attached study protocol.

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-11
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2028-07-01
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

A. General Inclusion Criteria:

i. All patients will be ≥ 40 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient primary Outcome	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.
Amputation Arm Outcome	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 Outcome Measures

Name	Time	Method
Patient outcome measures	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)
Amputation Arm Outcomes	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
Patient Outcome Measure	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)

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States