MRI-guided management of occlusive peripheral arterial disease
MRI Guided Management of Occlusive Peripheral Arterial Disease
This study is testing how MRI scans can help doctors understand plaque in the arteries of people with peripheral arterial disease and see if certain devices can make treatments safer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06782100 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify impenetrable plaque lesions in patients with peripheral arterial disease (PAD) and evaluate devices that minimize vessel wall injury during interventions. Patients will undergo MRI scans prior to planned percutaneous vascular interventions to assess plaque characteristics and predict procedural challenges. Additionally, patients facing lower limb amputation will have their limbs scanned to analyze plaque and test different devices for their effects on the vessel wall.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40 and older with Rutherford Category 4, 5, or 6 peripheral arterial disease and specific anatomical criteria.
Not a fit: Patients with Rutherford categories 0, 1, 2, or 3, or those with chronic total occlusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with peripheral arterial disease, potentially reducing complications during interventions.
How similar studies have performed: While this approach is observational, similar studies using MRI for vascular assessments have shown promise in improving procedural outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Trisha Roy, MD, PhD
- Email: troy@houstonmethodist.org
- Phone: 713-441-5200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.