Ovine Graft (Omniflow II) Versus PTFE in Below Knee Arterial Reconstruction
NCT ID: NCT00845585
Last Updated: 2015-07-17
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
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WITHDRAWN
NA
INTERVENTIONAL
2009-01-31
2015-01-31
Brief Summary
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Detailed Description
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Despite advances in endovascular therapies, arterial bypass to restore blood flow to a patent distal artery often is the best option in the management of lower extremity occlusive arterial disease. The greater saphenous vein is the conduit of choice for infrainguinal reconstructions - but it is not always available or is otherwise unusable in a significant percentage of patients. In those situations, arterial reconstruction using prosthetic material is an option. Synthetic and biological vascular grafts have been used for some three decades. With time, synthetic conduits tend to increase their thrombogenic potential rather than diminish it by formation of neointima. Over time biological grafts have become alternatives to synthetic materials, mainly in the more demanding applications below the knee. For various reasons most biological grafts have been withdrawn from the market and Omniflow II (Bio Nova International, Mel-bourne, Australia) is currently the only biological vascular prosthesis available for peripheral revascularisation.
Objective
The Omniflow II prosthesis is a biosynthetic device formed from stabilised sheep collagen with an integral polyester mesh. It is produced by inserting polyester mesh-covered mandrels beneath the cutaneous trunci muscle of adult sheep for a period of 12-14 weeks. The collagen-encapsulated tubes are harvested and stabilised using glutaraldehyde. The design provides long-term structural stability of the prosthesis and compliance that is similar to that of an autologous artery. There are no randomised studies comparing the Omniflow II graft to either autologous vein or PTFE. Extensive in vivo testing has been performed for safety and efficacy. The Omniflow graft is registered in Europe, Australia, Canada and in a range of countries in South America and South East Asia.
Methods
All patients between the ages 20 to 90 with peripheral arterial disease with severe, life-style limiting claudication, rest pain or tissue lesions based on occlusion of the femoral or popliteal artery can be considered, if no suitable vein is available for the reconstruction in infrapopliteal reconstructions. Written consent is obtained from all volunteering patients including willingness to participate in the follow-up process. Primary end point of the study is primary patency, defined by duplex scan as freedom from binary restenosis of 50%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Owniflow II
Below Knee Arterial Reconstruction
Patency, Reinterventions, Amputations, mortality
PTFE
Below Knee Arterial Reconstruction
Patency, Reinterventions, Amputations, mortality
Interventions
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Below Knee Arterial Reconstruction
Patency, Reinterventions, Amputations, mortality
Below Knee Arterial Reconstruction
Patency, Reinterventions, Amputations, mortality
Eligibility Criteria
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Inclusion Criteria
* Peripheral arterial occlusive disease with life-style limitation, claudication, rest pain, tissue loss,
* No suitable vein for reconstruction available
* Written consent obtained
Exclusion Criteria
* Patient younger than 20
* Pregnant women
* Myocardial infarction during past 30 days
* Stroke
* Life expectancy \< 1 year
20 Years
90 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Dept of Cardiovascular Surgery, University Hospital Bern
Principal Investigators
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Jürg Schmiedli, MD
Role: PRINCIPAL_INVESTIGATOR
Bern University Hospital
Locations
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Dept. of Cardiovascular Surgery
Bern, , Switzerland
Countries
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References
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Schmidli J, Savolainen H, Heller G, Widmer MK, Then-Schlagau U, Baumgartner I, Carrel TP. Bovine mesenteric vein graft (ProCol) in critical limb ischaemia with tissue loss and infection. Eur J Vasc Endovasc Surg. 2004 Mar;27(3):251-3. doi: 10.1016/j.ejvs.2003.12.001.
Miller JH, Foreman RK, Ferguson L, Faris I. Interposition vein cuff for anastomosis of prosthesis to small artery. Aust N Z J Surg. 1984 Jun;54(3):283-5. doi: 10.1111/j.1445-2197.1984.tb05318.x.
Kal'noi MP, Mikhailichenko IuP, Alabovskii IuI, Mishin FI. [Experience in medical service to the population in mass agricultural operations in Ipatovo District]. Zdravookhr Ross Fed. 1979;(7):10-3. No abstract available. Russian.
Walluscheck KP, Bierkandt S, Brandt M, Cremer J. Infrainguinal ePTFE vascular graft with bioactive surface heparin bonding. First clinical results. J Cardiovasc Surg (Torino). 2005 Aug;46(4):425-30.
Kersting S, Ockert D, Zimmermann T, Meichelbock W, Saeger HD, Bergert H. Infragenicular polytetrafluoroethylene bypass with tapered versus straight vascular grafts: results from a prospective multicenter cohort study. Ann Vasc Surg. 2004 Jul;18(4):440-7. doi: 10.1007/s10016-004-0052-3.
Panneton JM, Hollier LH, Hofer JM. Multicenter randomized prospective trial comparing a pre-cuffed polytetrafluoroethylene graft to a vein cuffed polytetrafluoroethylene graft for infragenicular arterial bypass. Ann Vasc Surg. 2004 Mar;18(2):199-206. doi: 10.1007/s10016-004-0012-y.
Jensen LP, Lepantalo M, Fossdal JE, Roder OC, Jensen BS, Madsen MS, Grenager O, Fasting H, Myhre HO, Baekgaard N, Nielsen OM, Helgstrand U, Schroeder TV. Dacron or PTFE for above-knee femoropopliteal bypass. a multicenter randomised study. Eur J Vasc Endovasc Surg. 2007 Jul;34(1):44-9. doi: 10.1016/j.ejvs.2007.01.016. Epub 2007 Apr 2.
Koch G, Gutschi S, Pascher O, Fruhwirth H, Glanzer H. Analysis of 274 Omniflow Vascular Prostheses implanted over an eight-year period. Aust N Z J Surg. 1997 Sep;67(9):637-9. doi: 10.1111/j.1445-2197.1997.tb04614.x.
Diehm N, Baumgartner I, Jaff M, Do DD, Minar E, Schmidli J, Diehm C, Biamino G, Vermassen F, Scheinert D, van Sambeek MR, Schillinger M. A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries. Eur Heart J. 2007 Apr;28(7):798-805. doi: 10.1093/eurheartj/ehl545. Epub 2007 Feb 22.
Other Identifiers
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114/08
Identifier Type: -
Identifier Source: org_study_id
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