Intervention Review

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Cryoplasty for peripheral arterial disease

  1. James E McCaslin1,*,
  2. Alina Andras2,
  3. Gerard Stansby3

Editorial Group: Cochrane Vascular Group

Published Online: 11 AUG 2013

Assessed as up-to-date: 26 OCT 2012

DOI: 10.1002/14651858.CD005507.pub3


How to Cite

McCaslin JE, Andras A, Stansby G. Cryoplasty for peripheral arterial disease. Cochrane Database of Systematic Reviews 2013, Issue 8. Art. No.: CD005507. DOI: 10.1002/14651858.CD005507.pub3.

Author Information

  1. 1

    Freeman Hospital, Northern Vascular Centre, Newcastle upon Tyne, Tyne & Wear, UK

  2. 2

    Freeman Hospital, Department of Vascular Surgery, Newcastle upon Tyne, UK

  3. 3

    University of Newcastle upon Tyne, Department of Surgery, Newcastle upon Tyne, UK

*James E McCaslin, Northern Vascular Centre, Freeman Hospital, Newcastle upon Tyne, Tyne & Wear, NE7 7DN, UK. mccaslin@doctors.org.uk.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 11 AUG 2013

SEARCH

References

References to studies included in this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
Banerjee 2012 {published and unpublished data}
  • Banerjee S. COBRA Trial: Cryoplasty or conventional balloon post-dilation of nitinol stents for revascularisation of peripheral arterial segments (http://www.tctmd.com/d.aspx?id=108821&ext=.pdf). TCT 2011: Transcatheter Cardiovascular Therapeutics 23rd Annual Scientific Symposium 2011.
  • Banerjee S, Das TS, Abu-Fadel MS, Dippel EJ, Shammas NW, Tran DL, et al. Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: The COBRA Trial. Journal of the American College of Cardiology 2012;60(15):1352-9.
Diaz 2011 {published data only}
  • Diaz ML, Urtasun F, Barberena J, Aranzadi C, Guillen-Grima F, Bilbao JI. Cryoplasty versus conventional angioplasty in femoropopliteal arterial recanalization: 3-year analysis of reintervention-free survival by treatment received. Cardiovascular and Interventional Radiology 2011;34(5):911-7.
Fossaceca 2011 {published data only}
  • Fossaceca R, Guzzardi G, Di Terlizzi M, Divenuto I, Malatesta E, Cerini P, et al. Comparison of cryoplasty and conventional angioplasty for treating stenotic-occlusive lesions of the femoropopliteal arteries in diabetic patients: immediate, mid-term and long-term results [Confronto tra crioplastica ed angioplastica convenzionale nel trattamento delle lesioni steno-ostruttive del tratto femoro-popliteo in pazienti diabetici: risultati immediati e a medio e lungo termine]. La Radiologia Medica 2012;117(7):1176-89.
Jahnke 2010 {published data only}
  • Jahnke T, Jamili A, Charalambous N, Huemme T, Trentmann J, Mueller-Huelsbeck S, et al. Mid-term results of the COLD study, a prospective, randomized single-center trial to compare cryoplasty versus "Plain old Balloon Angioplasty" (POBA) in the popliteal artery. Journal of Vascular and Interventional Radiology 2009; Vol. 20 Suppl:S89.
  • Jahnke T, Mueller-Huelsbeck S, Charalambous N, Trentmann J, Jamili A, Huemme TH, et al. Prospective, randomized single-center trial to compare cryoplasty versus conventional angioplasty in the popliteal artery: midterm results of the COLD study. Journal of Vascular and Interventional Radiology 2010;21(2):186-94.
Shammas 2012 {published data only}
  • Shammas NW, Coiner D, Shammas G, Christensen L, Jerin M. Percutaneous lower extremity arterial interventions using primary balloon angioplasty versus cryoplasty: a randomized pilot trial. Cardiovascular Revascularization Medicine 2012;13(3):172-6.
Spiliopoulos 2010 {published data only}
  • Spiliopoulos S, Katsanos K, Karnabatidis D, Diamantopoulos A, Kagadis GC, Christeas N, et al. Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic patients: long-term results from a prospective randomized single-center controlled trial. Cardiovascular and Interventional Radiology 2010;33(5):929-38.
Wang 2011 {published data only}
  • Wang X, Zhang B. The clinical application of cryoplasty for lower extremity arterial occlusive disease. Chinese Journal of Radiology 2011;45(9):863-6.

References to studies excluded from this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
Bakken 2008 {published data only}
  • Bakken AM, Saad WE, Davies MG. Cryoballoon angioplasty broadens the role of primary angioplasty and reduces adjuvant stenting in complex superficial femoral artery lesions. Journal of the American College of Surgeons 2008;206(3):524-32.
Banerjee 2009 {published data only}
  • Banerjee S, Brilakis ES, Das TS, Lichtenwalter CS. Treatment of complex superficial femoral artery lesions with PolarCath cryoplasty. American Journal of Cardiology 2009;104(3):447-9.
Basco 2012 {published data only}
  • Basco MT, Schlösser FJ, Muhs BE, Indes JE, Blume PA, Key JJ, et al. Lower extremity limb salvage with cryoplasty: a single-center cohort study. Vascular 2012;20(1):36-41.
Bosiers 2010 {published data only}
  • Bosiers M, Deloose K, Vermassen F, Schroë H, Lauwers G, Lansinck W, et al. The use of the cryoplasty technique in the treatment of infrapopliteal lesions for critical limb ischemia patients in a routine hospital setting: one-year outcome of the Cryoplasty CLIMB Registry. The Journal of Cardiovascular Surgery (Torino) 2010;51(2):193-202.
Das 2009 {published data only}
  • Das T, McNamara T, Gray B, Sedillo GJ, Turley BR, Kollmeyer K, et al. Cryoplasty therapy for limb salvage in patients with critical limb ischemia. Journal of Endovascular Therapy 2007;14(6):753-62.
  • Das TS, McNamara T, Gray B, Sedillo GJ, Turley BR, Kollmeyer K, et al. Primary cryoplasty therapy provides durable support for limb salvage in critical limb ischemia patients with infrapopliteal lesions: 12-month follow-up results from the BTK Chill Trial. Journal of Endovascular Therapy 2009;16(2 Suppl 2):II19-30.
  • McNamara TO, Anaya C, Quinn BJ. Interim results of cryoplasty in the below-the-knee CHILL study. Society of Interventional Radiology Annual Scientific Meeting. 2007:Abstract 110.
  • McNamara TO, Anaya CA, Quinn BJ. Interim results of cryoplasty in the below-the-knee CHILL study. Society of Interventional Radiology Annual Scientific Meeting. 2006:Abstract 3.
Fava 2004 {published data only}
  • Fava M, Loyola S, Polydorou A, Papapavlou P, Polydorou A, Mendiz O, et al. Cryoplasty for femoropopliteal arterial disease: late angiographic results of initial human experience. Journal of Vascular and Interventional Radiology 2004;15(11):1239-43.
FIX-IT Retro {unpublished data only}
  • Clinical outcomes of three different percutaneous revascularization strategies for the treatment of lifestyle limiting claudication: a retrospective analysis (FIX-IT Retro). http://clinicaltrials.gov/ct2/show/NCT00512720?term=NCT00512720&rank=1 (access 26 March 2013).
Gisbertz 2009 {published data only}
  • Gisbertz SS, de Borst GJ, Overtoom TT, Moll FL, de Vries JP. Initial results of concomitant cryoplasty after remote endarterectomy of the superficial femoral artery: a feasibility study (cryoplasty following remote endarterectomy). Vascular and Endovascular Surgery 2010;44(1):20-4.
Gonzalo 2010 {published data only}
  • Gonzalo B, Solanich T, Bellmunt S, Herranz C, González E, Arnedo G, et al. Cryoplasty as endovascular treatment in the femoropopliteal region: hemodynamic results and follow-up at one year. Annals of Vascular Surgery 2010;24(5):680-5.
Karthik 2007 {published data only}
Korteweg 2009 {published data only}
  • Korteweg MA, van Gils M, Hoedt MT, van der Valk PH, Tutein Noltenius RP, Avontuur JA, et al. Cryoplasty for occlusive disease of the femoropopliteal arteries: 1-year follow-up. Cardiovascular and Interventional Radiology 2009;32(2):221-5.
Laird 2006 {published data only}
  • Laird J, Jaff MR, Biamino G, McNamara T, Scheinert D, Zetterlund P, et al. Cryoplasty for the treatment of femoropopliteal arterial disease: results of a prospective, multicenter registry. Journal of Vascular Interventional Radiology 2005;16(8):1067-73.
  • Laird JR, Biamino G, McNamara T, Schneidert D, Zetterlund P, Moen E, et al. Cryoplasty for the treatment of femoropopliteal arterial disease: extended follow-up results. Journal of Endovascular Therapy 2006;13 Suppl II:II52-9.
Samson 2008 {published data only}
  • Samson RH, Schowalter DP, Lepore MR Jr, Ames S. CryoPlasty therapy of the superficial femoral and popliteal arteries: a single centre experience. Vascular and Endovascular Surgery 2007;40(6):446-50.
  • Samson RH, Showalter DP, Lepore M Jr, Nair DG, Merigliano K. CryoPlasty therapy of the superficial femoral and popliteal arteries: a reappraisal after 44 months' experience. Journal of Vascular Surgery 2008;48(3):634-7.
Schmieder 2010 {published data only}
  • Schmieder GC, Carroll M, Panneton JM. Poor outcomes with cryoplasty for lower extremity occlusive disease. Journal of Vascular Surgery 2010;52(2):362-8.
Shin 2010 {published data only}
  • Shin SH, Baril D, Chaer R, Makaroun M, Rhee R, Marone L. Cryoplasty offers no advantage over standard balloon angioplasty for the treatment of in-stent restenosis. Journal of Vascular Surgery 2010;52(3):803-4.
Silva 2011 {published data only}
  • Silva GV, Fernandes MR, Cardoso CO, Miranda WR, Strickman N, Mortazavi A, et al. Cryoplasty for peripheral artery disease in an unselected patient population in a tertiary center. Texas Heart Institute Journal 2011;38(2):122-6.

References to ongoing studies

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
ATHERO {unpublished data only}
  • ATHERO: Advanced technology halting early re-stenosis and occlusion. http://clinicaltrials.gov/ct2/show/NCT00407940?term=NCT00407940&rank=1 (accessed 26 March 2013).
The SFA Study CLASE {unpublished data only}
  • Prime time for superficial femoral artery (SFA) - The SFA study (CLASE). http://clinicaltrials.gov/ct2/show/NCT00902317?term=NCT00902317&rank=1 (accessed 26 March 2013).

Additional references

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
Adar 1989
  • Adar R, Critchfield GC, Eddy DM. A confidence profile analysis of the results of femoropopliteal percutaneous transluminal angioplasty in the treatment of lower-extremity ischemia. Journal of Vascular Surgery 1989;10(1):57-67.
Clowes 1983
Dewhurst 1991
  • Dewhurst G, Wood DA, Walker F, Lampe FC, Jeffreys M, Cooper M, et al. A population survey of cardiovascular disease in elderly people: design, methods and prevalence results. Age and Ageing 1991;20(5):353-60.
Dilley 1988
Dormandy 1991
  • Dormandy JA, Murray GD. The fate of the claudicant--a prospective study of 1969 claudicants. European Journal of Vascular Surgery 1991;5(2):131-3.
Fowkes 1991
  • Fowkes FG, Housley E, Cawood EH, Macintyre CC, Ruckley CV, Prescott RJ. Edinburgh Artery Study: prevalence of asymptomatic and symptomatic peripheral arterial disease in the general population. International Journal of Epidemiology 1991;20(2):384-92.
Fowkes 2001
  • Fowkes FG, Gillespie IN. Angioplasty (versus non surgical management) for intermittent claudication. Cochrane Database of Systematic Reviews 2001, Issue 3. [DOI: 10.1002/14651858.CD000017]
Gage 1967
  • Gage A, Fazekas G, Riley EE Jr. Freezing injury to large blood vessels in dogs. With comments on the effect of experimental freezing of bile ducts. Surgery 1967;61(5):748-54.
Grassl 2005
Higgins 2011
  • Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org..
Hirsch 2001
Karthik 2007a
Kessel 2008
Leu 1999
  • Leu AJ, Schneider E, Canova CR, Hoffmann U. Long-term results after recanalisation of chronic iliac artery occlusions by combined catheter therapy without stent placement. European Journal of Vascular and Endovascular Surgery 1999;18(6):499-505.
Leville 2006
  • Leville CD, Kashyap VS, Clair DG, Bena JF, Lyden SP, Greenberg RK, et al. Endovascular management of iliac artery occlusions: extending treatment to TransAtlantic Inter-Society Consensus class C and D patients. Journal of Vascular Surgery 2006;43(1):32-9.
London 1995
Long 1991
Martin 1995
  • Martin EC, Katzen BT, Benenati JF, Diethrich EB, Dorros G, Graor RA, et al. Multicenter trial of the wallstent in the iliac and femoral arteries. Journal of Vascular and Interventional Radiology 1995;6(6):843-9.
Mintz 1996
Murphy 1995
  • Murphy KD, Encarnacion CE, Le VA, Palmaz JC. Iliac artery stent placement with the Palmaz stent: follow-up study. Journal of Vascular and Interventional Radiology 1995;6(3):321-9.
Park 2005
  • Park KB, Do YS, Kim JH, Han YH, Kim DI, Kim DK, et al. Stent placement for chronic iliac arterial occlusive disease: the results of 10 years experience in a single institution. Korean Journal of Radiology 2005;6:256-66.
Park 2007
  • Park KB, Do YS, Kim DI, Kim DK, Kim YW, Shin SW, et al. The TransAtlantic InterSociety Consensus (TASC) classification system in iliac arterial stent placement: long-term patency and clinical limitations. Journal of Vascular and Interventional Radiology 2007;18(2):193-201.
Prasad 2012
  • Prasad A. Post-dilation of superficial femoral artery stents with cryoplasty: does the COBRA trial take a bite out of diabetic restenosis?. Journal of American College of Cardiology 2012;60(15):1360-3.
Sottiurai 1983
  • Sottiurai VS, Yao JS, Flinn WR, Batson RC. Intimal hyperplasia and neointima: an ultrastructural analysis of thrombosed grafts in humans. Surgery 1983;93(6):809-17.
White 2007
Wildgruber 2008

References to other published versions of this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
McCaslin 2007