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Peripheral Arterial Occlusive DiseaseNCT00845585

Ovine Graft (Omniflow II) Versus PTFE in Below Knee Arterial Reconstruction

A study testing Below Knee Arterial Reconstruction in people with Peripheral Arterial Occlusive Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The study intends to compare commonly used PTFE grafts with the biologic ovine graft Ominiflow II for below-knee bypass surgery in patients with peripheral artery occlusive disease with no autologous vein graft available. Read more about this study

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Peripheral Arterial Occlusive Disease
What is being tested?
Below Knee Arterial Reconstruction
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSwitzerland
Study dates
Jan 2009to Jan 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 20 to 90
  • Peripheral arterial occlusive disease with life-style limitation, claudication, rest pain, tissue loss,
  • No suitable vein for reconstruction available
  • Written consent obtained

Who cannot join

  • Acute limb threatening ischaemia
  • Patient younger than 20
  • Pregnant women
  • Myocardial infarction during past 30 days
  • Stroke
  • Life expectancy < 1 year

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Dept. of Cardiovascular Surgery

    Bern, 3010

Other trials in Switzerland

About this study

Official title: Ovine Graft (Omniflow II) Versus PTFE in Below Knee Arterial Reconstruction: A Prospective Randomized Multi Centre Study

The study intends to compare commonly used PTFE grafts with the biologic ovine graft Ominiflow II for below-knee bypass surgery in patients with peripheral artery occlusive disease with no autologous vein graft available. The hypothesis of this randomized trial is that that Omniflow II does not have a higher patency than PTFE over 36 months (one-sided test). An interim analysis will be performed at 18

Read the detailed description

Background

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%.

Being tested
Below Knee Arterial Reconstruction
Keywords
arterial reconstruction, bypass, below knee, PZFE, Ovine graft, Omniflow II, graft patency
Medical subject headings
Peripheral Arterial Occlusive Disease 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Below Knee Arterial ReconstructionDevice

    Patency, Reinterventions, Amputations, mortality

  • Below Knee Arterial ReconstructionDevice

    Patency, Reinterventions, Amputations, mortality

Study groups in NCT00845585
Study groupRoleWhat they receive
Owniflow IIActive comparatorNot described
Receives: Device: Below Knee Arterial Reconstruction
PTFEActive comparatorNot described
Receives: Device: Below Knee Arterial Reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. primary patency, defined by duplex scan as freedom from binary restenosis of 50%

    Measured: 36 months

Secondary outcomes (5)

  1. secondary patency

    Measured: 3 months

  2. limb salvage

    Measured: 6 months

  3. mortality

    Measured: 12 months

  4. infections

    Measured: 18 months

  5. reinterventions

    Measured: 24 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionJan 2015 (estimated)
  4. Study completionJan 2015 (estimated)

Why it stopped: found not enough centers for recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00845585
Sponsor's protocol ID
114/08
Status last verified
Nov 2010
First submitted
16 Feb 2009
Last updated
17 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 14760592

  • 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.

    PubMed 6380479

  • 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.

    PubMed 157650

  • 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.

    PubMed 16160689

  • 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.

    PubMed 15164262

  • 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.

    PubMed 15253256

  • 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.

    PubMed 17400486

  • 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.

    PubMed 9322703

  • 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.

    PubMed 17317699

Questions about this trial

What is this clinical trial studying?

A study testing Below Knee Arterial Reconstruction in people with Peripheral Arterial Occlusive Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

primary patency, defined by duplex scan as freedom from binary restenosis of 50% (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00845585, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2015.

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