MRI Guided Management of Occlusive Peripheral Arterial Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Peripheral Vascular Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Detailed description
Please see attached study protocol.
Primary outcome measures
- Patient primary Outcome [Time frame: Intraprocedural - the outcome is at the time of the procedure, it is not a follow up outcome.]
- Amputation Arm Outcome [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 outcome measures (3)
- Patient outcome measures [Time frame: Intraprocedural]
- Amputation Arm Outcomes [Time frame: From Experiment and Histologicla Examination]
- Patient Outcome Measure [Time frame: Intraprocedural]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Houston Methodist Hospital — Houston
Publications
- Csore J, Karmonik C, Wilhoit K, Buckner L, Roy TL. Automatic Classification of Magnetic Resonance Histology of Peripheral Arterial Chronic Total Occlusions Using a Variational Autoencoder: A Feasibility Study. Diagnostics (Basel). 2023 May 31;13(11):1925. doi: 10.3390/diagnostics13111925. PMID 37296778
- Barisano G, Sepehrband F, Ma S, Jann K, Cabeen R, Wang DJ, Toga AW, Law M. Clinical 7 T MRI: Are we there yet? A review about magnetic resonance imaging at ultra-high field. Br J Radiol. 2019 Feb;92(1094):20180492. doi: 10.1259/bjr.20180492. Epub 2018 Nov 1. PMID 30359093
- Shammas NW, Shammas WJ, Jones-Miller S, Torey JT, Armstrong EJ, Radaideh Q, Shammas GA. Optimal Vessel Sizing and Understanding Dissections in Infrapopliteal Interventions: Data From the iDissection Below the Knee Study. J Endovasc Ther. 2020 Aug;27(4):575-580. doi: 10.1177/1526602820924815. Epub 2020 May 18. PMID 32419593
- Horie K, Tanaka A, Taguri M, Kato S, Inoue N. Impact of Prolonged Inflation Times During Plain Balloon Angioplasty on Angiographic Dissection in Femoropopliteal Lesions. J Endovasc Ther. 2018 Dec;25(6):683-691. doi: 10.1177/1526602818799733. Epub 2018 Sep 11. PMID 30203701
- Ebisawa S, Kohsaka S, Muramatsu T, Kashima Y, Okamura A, Yamane M, Sakurada M, Matsuno S, Kijima M, Habara M. Derivation and validation of the J-CTO extension score for pre-procedural prediction of major adverse cardiac and cerebrovascular events in patients with chronic total occlusions. PLoS One. 2020 Sep 11;15(9):e0238640. doi: 10.1371/journal.pone.0238640. eCollection 2020. PMID 32915843
- Werncke T, Ringe KI, von Falck C, Kruschewski M, Wacker F, Meyer BC. Diagnostic confidence of run-off CT-angiography as the primary diagnostic imaging modality in patients presenting with acute or chronic peripheral arterial disease. PLoS One. 2015 Apr 2;10(3):e0119900. doi: 10.1371/journal.pone.0119900. eCollection 2015. PMID 25835948
- Mohebali J, Patel VI, Romero JM, Hannon KM, Jaff MR, Cambria RP, LaMuraglia GM. Acoustic shadowing impairs accurate characterization of stenosis in carotid ultrasound examinations. J Vasc Surg. 2015 Nov;62(5):1236-44. doi: 10.1016/j.jvs.2015.06.137. PMID 26506272
- Roy T, Liu G, Shaikh N, Dueck AD, Wright GA. Puncturing Plaques. J Endovasc Ther. 2017 Feb;24(1):35-46. doi: 10.1177/1526602816671135. Epub 2016 Sep 25. PMID 27659155
Identifiers
NCT: NCT06782100 · PRO00027258 · R01HL174587