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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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A prospective, single-center, real-world study on intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.
Intravascular ultrasound is considered important tool in endovascular procedures of coronary territory. Information such as vessel diameter, stent expansion, residual stenosis, helped in better understanding of the disease, treatment and stent behavior.
However, as a different anatomical territory with major hemodynamic differences, many of these concepts could not be reproduced in the femoropopliteal segment.
The purpose of this study is to correlate data collected by intraoperative intravascular ultrasound after the angioplasty procedure with stent placement in femoropopliteal arterial lesions and patency of this revascularization within 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravascular Ultrasound data | Experimental | Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device | Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Burden Measure | defined as = (external elastic membrane cross-sectional area - lumen cross-sectional area) ÷ external elastic membrane cross-sectional area | intraoperative |
| Reference Lumen Measure | defined as = (proximal reference lumen cross-sectional area + distal reference lumen cross-sectional area) x 0.5 | intraoperative |
| Reference Diameter Measure | defined as = (proximal reference diameter + distal reference diameter) x 0.5 | intraoperative |
| Stent/reference Diameter Ratio Measure | defined as = stent diameter ÷ reference diameter | intraoperative |
| Stent Expansion Ratio Measure | defined as = minimum stent cross-sectional area ÷ reference lumen cross-sectional area | intraoperative |
| Radial Stent Symmetry Index Measure | defined as = minimum ÷ maximum stent diameter at minimum stent cross-sectional area | intraoperative |
| Axial Stent Symmetry Index Measure | defined as = minimum ÷ maximum stent cross-sectional area | intraoperative |
| In Stent Restenosis |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater tha 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging. | intraoperative |
| Freedom of reintervention at each follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin A Geiger, MD | Contact | +55 19 35218936 | martinandreasgeiger@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Martin A Geiger, MD | University of Campinas, Brazil | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14226164 | Background | DOTTER CT, JUDKINS MP. TRANSLUMINAL TREATMENT OF ARTERIOSCLEROTIC OBSTRUCTION. DESCRIPTION OF A NEW TECHNIC AND A PRELIMINARY REPORT OF ITS APPLICATION. Circulation. 1964 Nov;30:654-70. doi: 10.1161/01.cir.30.5.654. No abstract available. | |
| 443484 | Background | Dettinger GB. Defending the military family. Am J Psychiatry. 1979 Jun;136(6):855-6. doi: 10.1176/ajp.136.6.855. No abstract available. |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 12 months (±30 days) |
defined as freedom from target lesion revascularization (TLR) |
| Baseline |
| Freedom of reintervention at each follow-up | defined as freedom from target lesion revascularization (TLR) | 1 month (± 7 days) |
| Freedom of reintervention at each follow-up | defined as freedom from target lesion revascularization (TLR) | 3 months (±30 days) |
| Freedom of reintervention at each follow-up | defined as freedom from target lesion revascularization (TLR) | 6 months (±30 days) |
| Freedom of reintervention at each follow-up | defined as freedom from target lesion revascularization (TLR) | 12 months (±30 days) |
| Limb-salvage rate | defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot) | Baseline |
| Limb-salvage rate | defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot) | 1 month (± 7 days) |
| Limb-salvage rate | defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot) | 3 months (±30 days) |
| Limb-salvage rate | defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot) | 6 months (±30 days) |
| Limb-salvage rate | defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot) | 12 months (±30 days) |
| Serious adverse events | defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. | Baseline |
| Serious adverse events | defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. | 1 month (± 7 days) |
| Serious adverse events | defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. | 3 months (±30 days) |
| Serious adverse events | defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. | 6 months (±30 days) |
| Serious adverse events | defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. | 12 months (±30 days) |
| Clinical success at follow-up | defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification. | Baseline |
| Clinical success at follow-up | defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification. | 1 month (± 7 days) |
| Clinical success at follow-up | defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification. | 3 months (±30 days) |
| Clinical success at follow-up | defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification. | 6 months (±30 days) |
| Clinical success at follow-up | defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification. | 12 months (±30 days) |
| 8281692 | Background | Pentecost MJ, Criqui MH, Dorros G, Goldstone J, Johnston KW, Martin EC, Ring EJ, Spies JB. Guidelines for peripheral percutaneous transluminal angioplasty of the abdominal aorta and lower extremity vessels. A statement for health professionals from a special writing group of the Councils on Cardiovascular Radiology, Arteriosclerosis, Cardio-Thoracic and Vascular Surgery, Clinical Cardiology, and Epidemiology and Prevention, the American Heart Association. Circulation. 1994 Jan;89(1):511-31. doi: 10.1161/01.cir.89.1.511. No abstract available. |
| 8850658 | Background | Martin EC, Katzen BT, Benenati JF, Diethrich EB, Dorros G, Graor RA, Horton KM, Iannone LA, Isner JM, Ramee SR, et al. Multicenter trial of the wallstent in the iliac and femoral arteries. J Vasc Interv Radiol. 1995 Nov-Dec;6(6):843-9. doi: 10.1016/s1051-0443(95)71198-8. |
| 11012429 | Background | Lammer J, Dake MD, Bleyn J, Katzen BT, Cejna M, Piquet P, Becker GJ, Settlage RA. Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent-graft. International Trial Study Group. Radiology. 2000 Oct;217(1):95-104. doi: 10.1148/radiology.217.1.r00se0595. |
| 9068071 | Background | Gray BH, Olin JW. Limitations of percutaneous transluminal angioplasty with stenting for femoropopliteal arterial occlusive disease. Semin Vasc Surg. 1997 Mar;10(1):8-16. |
| 17920306 | Background | Ferreira M, Lanziotti L, Monteiro M, Abuhadba G, Capotorto LF, Nolte L, Fearnot N. Superficial femoral artery recanalization with self-expanding nitinol stents: long-term follow-up results. Eur J Vasc Endovasc Surg. 2007 Dec;34(6):702-8. doi: 10.1016/j.ejvs.2007.07.025. Epub 2007 Oct 24. |
| 19642788 | Background | Bosiers M, Torsello G, Gissler HM, Ruef J, Muller-Hulsbeck S, Jahnke T, Peeters P, Daenens K, Lammer J, Schroe H, Mathias K, Koppensteiner R, Vermassen F, Scheinert D. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. 2009 Jun;16(3):261-9. doi: 10.1583/08-2676.1. |
| 24754279 | Background | Laird JR, Jain A, Zeller T, Feldman R, Scheinert D, Popma JJ, Armstrong EJ, Jaff MR; Complete SE Investigators. Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial. J Endovasc Ther. 2014 Apr;21(2):202-12. doi: 10.1583/13-4548R.1. |