MRI-guided management of occlusive peripheral arterial disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Houston Methodist Hospital
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Trisha Roy, MD, PhD
• Email: troy@houstonmethodist.org
• Phone: 713-441-5200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.