Clinical trial NCT05916950 - References

Peripheral Artery Disease — The THOR IDE Study

Citation(s)

•   Adams G, Soukas PA, Mehrle A, Bertolet B, Armstrong EJ
  Intravascular Lithotripsy for Treatment of Calcified Infrapopliteal Lesions: Results from the Disrupt PAD III Observational Study. J Endovasc Ther. 2022 Feb;29(1):76-83. doi: 10.1177/15266028211032953. Epub 2021 Aug 12.
•   Brodmann M, Werner M, Brinton TJ, Illindala U, Lansky A, Jaff MR, Holden A
  Safety and Performance of Lithoplasty for Treatment of Calcified Peripheral Artery Lesions. J Am Coll Cardiol. 2017 Aug 15;70(7):908-910. doi: 10.1016/j.jacc.2017.06.022. No abstract available.
•   Brodmann M, Werner M, Holden A, Tepe G, Scheinert D, Schwindt A, Wolf F, Jaff M, Lansky A, Zeller T
  Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II. Catheter Cardiovasc Interv. 2019 Feb 1;93(2):335-342. doi: 10.1002/ccd.27943. Epub 2018 Nov 25.
•   Burckenmeyer F, Aschenbach R, Diamantis I, Teichgraber U
  Excimer laser atherectomy in complex peripheral artery disease: a prospective European registry. J Cardiovasc Surg (Torino). 2021 Apr;62(2):153-161. doi: 10.23736/S0021-9509.21.11569-1. Epub 2021 Jan 22.
•   Capek P, McLean GK, Berkowitz HD
  Femoropopliteal angioplasty. Factors influencing long-term success. Circulation. 1991 Feb;83(2 Suppl):I70-80.
•   Caro J, Migliaccio-Walle K, Ishak KJ, Proskorovsky I
  The morbidity and mortality following a diagnosis of peripheral arterial disease: long-term follow-up of a large database. BMC Cardiovasc Disord. 2005 Jun 22;5:14. doi: 10.1186/1471-2261-5-14.
•   Dattilo R, Himmelstein SI, Cuff RF
  The COMPLIANCE 360 degrees Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease. J Invasive Cardiol. 2014 Aug;26(8):355-60.
•   Dave RM, Patlola R, Kollmeyer K, Bunch F, Weinstock BS, Dippel E, Jaff MR, Popma J, Weissman N; CELLO Investigators
  Excimer laser recanalization of femoropopliteal lesions and 1-year patency: results of the CELLO registry. J Endovasc Ther. 2009 Dec;16(6):665-75. doi: 10.1583/09-2781.1.
•   Dearing DD, Patel KR, Compoginis JM, Kamel MA, Weaver FA, Katz SG
  Primary stenting of the superficial femoral and popliteal artery. J Vasc Surg. 2009 Sep;50(3):542-7. doi: 10.1016/j.jvs.2009.04.019. Epub 2009 Jun 21.
•   Dieter RS, Chu WW, Pacanowski JP Jr, McBride PE, Tanke TE
  The significance of lower extremity peripheral arterial disease. Clin Cardiol. 2002 Jan;25(1):3-10. doi: 10.1002/clc.4950250103.
•   Dosluoglu HH, Cherr GS, Lall P, Harris LM, Dryjski ML
  Stenting vs above knee polytetrafluoroethylene bypass for TransAtlantic Inter-Society Consensus-II C and D superficial femoral artery disease. J Vasc Surg. 2008 Nov;48(5):1166-74. doi: 10.1016/j.jvs.2008.06.006. Epub 2008 Aug 9.
•   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.
•   Gandini R, Pratesi G, Merolla S, Scaggiante J, Chegai F
  A Single-Center Experience With Phoenix Atherectomy System in Patients With Moderate to Heavily Calcified Femoropopliteal Lesions. Cardiovasc Revasc Med. 2020 May;21(5):676-681. doi: 10.1016/j.carrev.2019.08.019. Epub 2019 Aug 23.
•   Guez D, Hansberry DR, Gonsalves CF, Eschelman DJ, Parker L, Rao VM, Levin DC
  Recent Trends in Endovascular and Surgical Treatment of Peripheral Arterial Disease in the Medicare Population. AJR Am J Roentgenol. 2020 May;214(5):962-966. doi: 10.2214/AJR.19.21967. Epub 2020 Feb 25.
•   Herten M, Torsello GB, Schonefeld E, Stahlhoff S
  Critical appraisal of paclitaxel balloon angioplasty for femoral-popliteal arterial disease. Vasc Health Risk Manag. 2016 Aug 29;12:341-56. doi: 10.2147/VHRM.S81122. eCollection 2016.
•   Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR
  Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.
•   Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation
  ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
•   Iida O, Urasawa K, Shibata Y, Yamamoto Y, Ando H, Fujihara M, Nakama T, Miyashita Y, Mori S, Diaz-Cartelle J, Soga Y
  Clinical Safety and Efficacy of Rotational Atherectomy in Japanese Patients with Peripheral Arterial Disease Presenting Femoropopliteal Lesions: The J-SUPREME and J-SUPREME II Trials. J Endovasc Ther. 2022 Apr;29(2):240-247. doi: 10.1177/15266028211045700. Epub 2021 Sep 13.
•   Inoue S, Koyama H, Miyata T, Shigematsu H
  Pathogenetic heterogeneity of in-stent lesion formation in human peripheral arterial disease. J Vasc Surg. 2002 Apr;35(4):672-8. doi: 10.1067/mva.2002.122021.
•   Isner JM, Rosenfield K
  Redefining the treatment of peripheral artery disease. Role of percutaneous revascularization. Circulation. 1993 Oct;88(4 Pt 1):1534-57. doi: 10.1161/01.cir.88.4.1534. No abstract available.
•   Krankenberg H, Schluter M, Steinkamp HJ, Burgelin K, Scheinert D, Schulte KL, Minar E, Peeters P, Bosiers M, Tepe G, Reimers B, Mahler F, Tubler T, Zeller T
  Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation. 2007 Jul 17;116(3):285-92. doi: 10.1161/CIRCULATIONAHA.107.689141. Epub 2007 Jun 25.
•   Lanzer P, Boehm M, Sorribas V, Thiriet M, Janzen J, Zeller T, St Hilaire C, Shanahan C
  Medial vascular calcification revisited: review and perspectives. Eur Heart J. 2014 Jun 14;35(23):1515-25. doi: 10.1093/eurheartj/ehu163. Epub 2014 Apr 16.
•   Lehto S, Niskanen L, Suhonen M, Ronnemaa T, Laakso M
  Medial artery calcification. A neglected harbinger of cardiovascular complications in non-insulin-dependent diabetes mellitus. Arterioscler Thromb Vasc Biol. 1996 Aug;16(8):978-83. doi: 10.1161/01.atv.16.8.978.
•   Minar E, Pokrajac B, Maca T, Ahmadi R, Fellner C, Mittlbock M, Seitz W, Wolfram R, Potter R
  Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty : results of a prospective randomized study. Circulation. 2000 Nov 28;102(22):2694-9. doi: 10.1161/01.cir.102.22.2694.
•   Mueller T, Hinterreiter F, Poelz W, Haltmayer M, Dieplinger B
  Mortality rates at 10 years are higher in diabetic than in non-diabetic patients with chronic lower extremity peripheral arterial disease. Vasc Med. 2016 Oct;21(5):445-452. doi: 10.1177/1358863X16643603. Epub 2016 Apr 11.
•   Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K
  Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
•   Patel MR, Conte MS, Cutlip DE, Dib N, Geraghty P, Gray W, Hiatt WR, Ho M, Ikeda K, Ikeno F, Jaff MR, Jones WS, Kawahara M, Lookstein RA, Mehran R, Misra S, Norgren L, Olin JW, Povsic TJ, Rosenfield K, Rundback J, Shamoun F, Tcheng J, Tsai TT, Suzuki Y, Vranckx P, Wiechmann BN, White CJ, Yokoi H, Krucoff MW
  Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. 2015 Mar 10;65(9):931-41. doi: 10.1016/j.jacc.2014.12.036. Erratum In: J Am Coll Cardiol. 2015 Jun 16;65(23):2578-9.
•   Pokrajac B, Potter R, Wolfram RM, Budinsky AC, Kirisits C, Lileg B, Mendel H, Sabeti S, Schmid R, Minar E
  Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study. Radiother Oncol. 2005 Jan;74(1):3-9. doi: 10.1016/j.radonc.2004.08.015.
•   Radaideh Q, Shammas NW, Shammas WJ, Shammas GA
  Shockwave Lithoplasty in Combination With Atherectomy in Treating Severe Calcified Femoropopliteal and Iliac Artery Disease: A Single-Center Experience. Cardiovasc Revasc Med. 2021 Jan;22:66-70. doi: 10.1016/j.carrev.2020.06.015. Epub 2020 Jun 11.
•   Roberts D, Niazi K, Miller W, Krishnan P, Gammon R, Schreiber T, Shammas NW, Clair D; DEFINITIVE Ca(+)(+) Investigators
  Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: final results of the DEFINITIVE Ca(+)(+) trial. Catheter Cardiovasc Interv. 2014 Aug 1;84(2):236-44. doi: 10.1002/ccd.25384. Epub 2014 Feb 5.
•   Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc
  Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104.
•   Rocha-Singh KJ, Zeller T, Jaff MR
  Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. 2014 May 1;83(6):E212-20. doi: 10.1002/ccd.25387. Epub 2014 Feb 10.
•   Sabeti S, Schillinger M, Amighi J, Sherif C, Mlekusch W, Ahmadi R, Minar E
  Primary patency of femoropopliteal arteries treated with nitinol versus stainless steel self-expanding stents: propensity score-adjusted analysis. Radiology. 2004 Aug;232(2):516-21. doi: 10.1148/radiol.2322031345.
•   Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E
  Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.
•   Schlager O, Dick P, Sabeti S, Amighi J, Mlekusch W, Minar E, Schillinger M
  Long-segment SFA stenting--the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther. 2005 Dec;12(6):676-84. doi: 10.1583/05-1672.1.
•   Schramm KM, DeWitt PE, Dybul S, Rochon PJ, Patel P, Hieb RA, Rogers RK, Ryu RK, Wolhauer M, Hong K, Trivedi PS
  Recent Trends in Clinical Setting and Provider Specialty for Endovascular Peripheral Artery Disease Interventions for the Medicare Population. J Vasc Interv Radiol. 2020 Apr;31(4):614-621.e2. doi: 10.1016/j.jvir.2019.10.025. Epub 2020 Feb 29.
•   Shammas NW, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, Micari A, Lee A, Metzger C, Palena LM, Rundback J; EX-PAD-03 Investigators
  Acute and 30-Day Safety and Effectiveness Evaluation of Eximo Medical's B-Laser, a Novel Atherectomy Device, in Subjects Affected With Infrainguinal Peripheral Arterial Disease: Results of the EX-PAD-03 Trial. Cardiovasc Revasc Med. 2020 Jan;21(1):86-92. doi: 10.1016/j.carrev.2018.11.022. Epub 2018 Nov 29.
•   Shammas NW, Lam R, Mustapha J, Ellichman J, Aggarwala G, Rivera E, Niazi K, Balar N
  Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial. J Endovasc Ther. 2012 Aug;19(4):480-8. doi: 10.1583/JEVT-12-3815MR.1.
•   Shammas NW, Shammas GA, Jones-Miller S, Shammas WJ, Bou-Dargham B, Shammas AN, Banerjee S, Rachwan RJ, Daher GE
  Long-term outcomes with Jetstream atherectomy with or without drug coated balloons in treating femoropopliteal arteries: A single center experience (JET-SCE). Cardiovasc Revasc Med. 2018 Oct;19(7 Pt A):771-777. doi: 10.1016/j.carrev.2018.02.003. Epub 2018 Feb 9.
•   Shanahan CM, Cary NR, Salisbury JR, Proudfoot D, Weissberg PL, Edmonds ME
  Medial localization of mineralization-regulating proteins in association with Monckeberg's sclerosis: evidence for smooth muscle cell-mediated vascular calcification. Circulation. 1999 Nov 23;100(21):2168-76. doi: 10.1161/01.cir.100.21.2168.
•   Soor GS, Vukin I, Leong SW, Oreopoulos G, Butany J
  Peripheral vascular disease: who gets it and why? A histomorphological analysis of 261 arterial segments from 58 cases. Pathology. 2008 Jun;40(4):385-91. doi: 10.1080/00313020802036764.
•   Stavroulakis K, Bisdas T, Torsello G, Tsilimparis N, Damerau S, Argyriou A
  Intravascular Lithotripsy and Drug-Coated Balloon Angioplasty for Severely Calcified Femoropopliteal Arterial Disease. J Endovasc Ther. 2023 Feb;30(1):106-113. doi: 10.1177/15266028221075563. Epub 2022 Feb 7.
•   Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators
  Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.
•   Thompson B, Towler DA
  Arterial calcification and bone physiology: role of the bone-vascular axis. Nat Rev Endocrinol. 2012 Sep;8(9):529-43. doi: 10.1038/nrendo.2012.36. Epub 2012 Apr 3.
•   van der Zaag ES, Legemate DA, Prins MH, Reekers JA, Jacobs MJ
  Angioplasty or bypass for superficial femoral artery disease? A randomised controlled trial. Eur J Vasc Endovasc Surg. 2004 Aug;28(2):132-7. doi: 10.1016/j.ejvs.2004.04.003.
•   Walker KL, Nolan BW, Columbo JA, Rzucidlo EM, Goodney PP, Walsh DB, Atkinson BJ, Powell RJ
  Lesion complexity drives the cost of superficial femoral artery endovascular interventions. J Vasc Surg. 2015 Oct;62(4):998-1002. doi: 10.1016/j.jvs.2015.04.450. Epub 2015 Jul 21.
•   Yamamoto Y, Kawarada O, Ando H, Anzai H, Zen K, Tamura K, Tsukahara K, Tsubakimoto Y, Toma M, Nakamura S, Nakamura H, Hozawa K, Yokoi Y, Yasuda S
  Effects of high-speed rotational atherectomy in peripheral artery disease patients with calcified lesions: a retrospective multicenter registry. Cardiovasc Interv Ther. 2020 Oct;35(4):393-397. doi: 10.1007/s12928-020-00643-9. Epub 2020 Feb 28.
•   Zeller T, Langhoff R, Rocha-Singh KJ, Jaff MR, Blessing E, Amann-Vesti B, Krzanowski M, Peeters P, Scheinert D, Torsello G, Sixt S, Tepe G; DEFINITIVE AR Investigators
  Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study. Circ Cardiovasc Interv. 2017 Sep;10(9):e004848. doi: 10.1161/CIRCINTERVENTIONS.116.004848.
•   Zeller T, Tiefenbacher C, Steinkamp HJ, Langhoff R, Wittenberg G, Schluter M, Buergelin K, Rastan A, Krumsdorf U, Sixt S, Schulte CL, Tubler T, Krankenberg H
  Nitinol stent implantation in TASC A and B superficial femoral artery lesions: the Femoral Artery Conformexx Trial (FACT). J Endovasc Ther. 2008 Aug;15(4):390-8. doi: 10.1583/08-2461.1.

The THOR IDE Study

Details for clinical trial NCT05916950