NCT00845585

Brief 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. 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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 17, 2015

Status Verified

November 1, 2010

Enrollment Period

6 years

First QC Date

February 16, 2009

Last Update Submit

July 16, 2015

Conditions

Peripheral Arterial Occlusive Disease

Keywords

arterial reconstructionbypassbelow kneePZFEOvine graftOmniflow IIgraft patency

Outcome Measures

Primary Outcomes (1)

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

    36 months

Secondary Outcomes (5)

  • secondary patency

    3 months

  • limb salvage

    6 months

  • mortality

    12 months

  • infections

    18 months

  • reinterventions

    24 and 36 months

Study Arms (2)

Owniflow II

ACTIVE COMPARATOR
Device: Below Knee Arterial Reconstruction

PTFE

ACTIVE COMPARATOR
Device: Below Knee Arterial Reconstruction

Interventions

Below Knee Arterial ReconstructionDEVICE

Patency, Reinterventions, Amputations, mortality

Owniflow II

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Cardiovascular Surgery

Bern, 3010, Switzerland

Location

Related Publications (9)

  • 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.

    PMID: 14760592BACKGROUND

  • 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.

    PMID: 6380479BACKGROUND

  • 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.

    PMID: 157650BACKGROUND

  • 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.

    PMID: 16160689BACKGROUND

  • 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.

    PMID: 15164262BACKGROUND

  • 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.

    PMID: 15253256BACKGROUND

  • 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.

    PMID: 17400486BACKGROUND

  • 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.

    PMID: 9322703BACKGROUND

  • 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.

    PMID: 17317699BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Study Officials

  • Jürg Schmiedli, MD

    Bern University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2009

First Posted

February 18, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 17, 2015

Record last verified: 2010-11

Locations

CH(1)