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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL174587 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
Please see attached study protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). | ||
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient primary Outcome | PVI failure due to inability to cross the target plaque with a guidewire. | Intraprocedural - the outcome is at the time of the procedure, it is not a follow up outcome. |
| Amputation Arm Outcome | Presence of dissections on histology (number of dissections i.e. count, idissection score) | From Experiment and detected during Histological Evaluation (there is no timeframe from this as it is after the experiment on histological analysis) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient outcome measures |
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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
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For Revascularization Arm: Patients will be enrolled from Vascular surgical Care at Houston Methodist Hospital and undergoing lower limb PVI.
For Amputation Arm: Patients undergoing Major lower limb amputation at Houston Methodist Hospital with PAD.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trisha Roy, MD, PhD | Contact | 713-441-5200 | troy@houstonmethodist.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37296778 | Background | 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. | |
| 30359093 | Background | 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. |
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Based on ethical and legal considerations, only the following data produced in the course of the project will be preserved and shared on a data repository platform: MRI, angiography, Cone Beam CT, and histology data.The final dataset will include self-reported demographic data. We will share de-identified individualparticipant level (IPD) data. Appropriate measures such as assigning a random code to each participant will be used for data de-identification and sharing, and informed consent forms will reflect those plans.
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Blood vessel samples
| Intraprocedural |
| Amputation Arm Outcomes |
| From Experiment and Histologicla Examination |
| Patient Outcome Measure | Hypothesis: Women will have less MRI-defined hard lesions and plaques that are easier to cross Comparison Groups: Women vs. Men Primary Outcome: PVI failure due to inability to cross the target plaque with a guidewire (record number of hard lesions i.e. count, comparing men and women) | Intraprocedural |
| 32419593 | Background | 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. |
| 30203701 | Background | 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. |
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| 37116524 | Background | 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. |
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| 31401843 | Background | 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. |
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| 31727459 | Background | 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. |
| 36342173 | Background | 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. |
| 16291066 | Background | 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. |