MRI Guided Management of Occlusive Peripheral Arterial Disease
NCT ID: NCT06782100
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
175 participants
OBSERVATIONAL
2024-07-01
2029-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Magnetic Resonance Imaging to Identify Characteristics of Plaque Build-Up in People With Peripheral Arterial Disease
NCT00520312
Imaging of Plaque With Magnetic Resonance Imaging (MRI)
NCT00115856
Technical Innovation Protocol for MR & US Plaque Imaging: Reproducibility.
NCT01196221
MRI-Guided Balloon Angioplasty to Treat Blood Flow Blockage in the Legs
NCT00094783
Magnetic Resonance Imaging of Narrowed Arteries
NCT00029575
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Amputation Arm
In an ex vivo human cadaveric model, post-PVI histopathologic analysis will be used to uncover the impact of plaque type on device safety (POBA versus atherectomy) and performance, facilitating evidence-based device selection to mitigate complications. Using a randomized approach, the investigator will compare plain balloon angioplasty to orbital atherectomy prior to angioplasty in amputated legs from PAD patients with plaques characterized into 4 categories based their MRI-histology: concentric calcium, eccentric calcium, fibrous plaque, and soft plaques (smooth muscle and thrombus).
No interventions assigned to this group
Revascularization Arm
Patient Imaging Protocol: Scans will be performed on 100 patients enrolled into the study population using a 3T MAGNETOM scanner (Siemens) at the Houston Methodist Research Institute Translational Imaging Center. The investigator will use pre-operative images captured using the optimized MRI-histology sequences to score lesions. Physicians performing PVI will be blinded to the pre-operative MRI-histology images and anatomic scores and will make treatment decisions based on their standard of care. The investigator expect MRI-histology plaque scores predict which patients will have PVI failures due to untraversable plaque, and it may also foresee the potential need of adjunctive devices or alternative approaches for successful PVI
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
ii. Aim 2 only - Chronic total occlusions
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
The Methodist Hospital Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Triisha Roy
Vascular Surgeon- Scientist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Houston Methodist Hospital
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Trisha Roy, MD, PhD
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Ebert MLA, Schmidt VF, Pfaff L, von Thaden A, Kimm MA, Wildgruber M. Animal Models of Neointimal Hyperplasia and Restenosis: Species-Specific Differences and Implications for Translational Research. JACC Basic Transl Sci. 2021 Aug 11;6(11):900-917. doi: 10.1016/j.jacbts.2021.06.006. eCollection 2021 Nov.
Hsu CC, Kwan GN, Singh D, Rophael JA, Anthony C, van Driel ML. Angioplasty versus stenting for infrapopliteal arterial lesions in chronic limb-threatening ischaemia. Cochrane Database Syst Rev. 2018 Dec 8;12(12):CD009195. doi: 10.1002/14651858.CD009195.pub2.
Jones DW, Schanzer A, Zhao Y, MacKenzie TA, Nolan BW, Conte MS, Goodney PP; Vascular Study Group of New England. Growing impact of restenosis on the surgical treatment of peripheral arterial disease. J Am Heart Assoc. 2013 Nov 25;2(6):e000345. doi: 10.1161/JAHA.113.000345.
Nolan BW, De Martino RR, Stone DH, Schanzer A, Goodney PP, Walsh DW, Cronenwett JL; Vascular Study Group of New England. Prior failed ipsilateral percutaneous endovascular intervention in patients with critical limb ischemia predicts poor outcome after lower extremity bypass. J Vasc Surg. 2011 Sep;54(3):730-5; discussion 735-6. doi: 10.1016/j.jvs.2011.03.236. Epub 2011 Jul 29.
Roy TL, Chen HJ, Dueck AD, Wright GA. Magnetic resonance imaging characteristics of lesions relate to the difficulty of peripheral arterial endovascular procedures. J Vasc Surg. 2018 Jun;67(6):1844-1854.e2. doi: 10.1016/j.jvs.2017.09.034. Epub 2017 Dec 13.
Bradbury AW, Moakes CA, Popplewell M, Meecham L, Bate GR, Kelly L, Chetter I, Diamantopoulos A, Ganeshan A, Hall J, Hobbs S, Houlind K, Jarrett H, Lockyer S, Malmstedt J, Patel JV, Patel S, Rashid ST, Saratzis A, Slinn G, Scott DJA, Zayed H, Deeks JJ; BASIL-2 Investigators. A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial. Lancet. 2023 May 27;401(10390):1798-1809. doi: 10.1016/S0140-6736(23)00462-2. Epub 2023 Apr 25.
Kristensen MT, Holm G, Kirketerp-Moller K, Krasheninnikoff M, Gebuhr P. Very low survival rates after non-traumatic lower limb amputation in a consecutive series: what to do? Interact Cardiovasc Thorac Surg. 2012 May;14(5):543-7. doi: 10.1093/icvts/ivr075. Epub 2012 Jan 31.
Misra S, Shishehbor MH, Takahashi EA, Aronow HD, Brewster LP, Bunte MC, Kim ESH, Lindner JR, Rich K; American Heart Association Council on Peripheral Vascular Disease; Council on Clinical Cardiology; and Council on Cardiovascular and Stroke Nursing. Perfusion Assessment in Critical Limb Ischemia: Principles for Understanding and the Development of Evidence and Evaluation of Devices: A Scientific Statement From the American Heart Association. Circulation. 2019 Sep 17;140(12):e657-e672. doi: 10.1161/CIR.0000000000000708. Epub 2019 Aug 12.
Criqui MH, Matsushita K, Aboyans V, Hess CN, Hicks CW, Kwan TW, McDermott MM, Misra S, Ujueta F; American Heart Association Council on Epidemiology and Prevention; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Lifestyle and Cardiometabolic Health; Council on Peripheral Vascular Disease; and Stroke Council. Lower Extremity Peripheral Artery Disease: Contemporary Epidemiology, Management Gaps, and Future Directions: A Scientific Statement From the American Heart Association. Circulation. 2021 Aug 31;144(9):e171-e191. doi: 10.1161/CIR.0000000000001005. Epub 2021 Jul 28.
Creager MA, Matsushita K, Arya S, Beckman JA, Duval S, Goodney PP, Gutierrez JAT, Kaufman JA, Joynt Maddox KE, Pollak AW, Pradhan AD, Whitsel LP. Reducing Nontraumatic Lower-Extremity Amputations by 20% by 2030: Time to Get to Our Feet: A Policy Statement From the American Heart Association. Circulation. 2021 Apr 27;143(17):e875-e891. doi: 10.1161/CIR.0000000000000967. Epub 2021 Mar 25.
Zia S, Juneja A, Shams S, Faheem B, Shariff MA, Singh K, Schor J, Deitch J. Contemporary outcomes of infrapopliteal atherectomy with angioplasty versus balloon angioplasty alone for critical limb ischemia. J Vasc Surg. 2020 Jun;71(6):2056-2064. doi: 10.1016/j.jvs.2019.08.254. Epub 2019 Nov 11.
Farber A, Menard MT, Conte MS, Kaufman JA, Powell RJ, Choudhry NK, Hamza TH, Assmann SF, Creager MA, Cziraky MJ, Dake MD, Jaff MR, Reid D, Siami FS, Sopko G, White CJ, van Over M, Strong MB, Villarreal MF, McKean M, Azene E, Azarbal A, Barleben A, Chew DK, Clavijo LC, Douville Y, Findeiss L, Garg N, Gasper W, Giles KA, Goodney PP, Hawkins BM, Herman CR, Kalish JA, Koopmann MC, Laskowski IA, Mena-Hurtado C, Motaganahalli R, Rowe VL, Schanzer A, Schneider PA, Siracuse JJ, Venermo M, Rosenfield K; BEST-CLI Investigators. Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia. N Engl J Med. 2022 Dec 22;387(25):2305-2316. doi: 10.1056/NEJMoa2207899. Epub 2022 Nov 7.
Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. doi: 10.1016/S0140-6736(05)67698-2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO00027258
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.