NCT06782100 MRI Guided Management of Occlusive Peripheral Arterial Disease
| NCT ID | NCT06782100 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Methodist Hospital Research Institute |
| Condition | Peripheral Vascular Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 175 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 175 participants in total. It began in 2024-07-01 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06782100 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Vascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06782100 currently recruiting?
Yes, NCT06782100 is actively recruiting participants. Contact the research team at troy@houstonmethodist.org for enrollment information.
Where is the NCT06782100 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06782100 clinical trial?
NCT06782100 is sponsored by The Methodist Hospital Research Institute. The trial plans to enroll 175 participants.