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Completed

NCT Number: NCT01285986

Scandinavian Miller Collar Study

Randomized study to evaluate the effect of adding a vein collar at the distal anastomosis to PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary patency, and limb salvage

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of CardioVascular Surgery, University Hospital

Linköping, 581 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Critical limb ischemia
  • Need for bypass surgery

Exclusion criteria

  • Can not participate in follow-up
  • Has suitable saphenous vein

Treatment and study plan

Vein collar at the distal anastomosis

Procedure

Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis

Primary outcomes

  1. Primary graft patency

    Time frame: Up to five years

    Follow-up at 1, 3, 6, and 12. Thereafter at most 5 years or until death of patient or amputation of limb. Primary graft patency = patent graft without any intervention to open up or prevent a graft ocklusion. Methods used for verification of patency: angiography, duplex, an improved ankle-brachial index was mantained, palpable pulse, or bi- or triphasic Doppler signal over the graft.

Secondary outcomes

  1. Secondary Patency

    Time frame: Up to five years

    Secondary patency = patent graft after one or several interventions to open up or prevent a graft occlusion. Methods used for verification of secondary patency: angiography, duplex, an improved ankle-brachial index was mantained, palpable pulse, or bi- or triphasic Doppler signal over the graft.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Collaborators

  • Aalborg University Hospital
  • Borås Lasarett
  • Department of Surgery, Kärnsjukhuset, Skövde, Sweden
  • Department of Surgery, Lasarettet, Motala, Sweden
  • Department of Surgery, Lasarettet, Nyköping, Sweden
  • Department of Surgery, Lasarettet, Skellefteå, Sweden
  • Department of Surgery, Lasarettet, Växjö, Sweden
  • Department of Surgery, Lasarettet, Örebro, Sweden
  • Department of Surgery, Lasarettet, Östersund, Sweden
  • Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan-Vänersborg, Sweden
  • Department of Surgery, S:t Görans Sjukhus, Stockholm, Sweden
  • Department of Surgery, Södersjukhuset, Stockholm, Sweden
  • Department of Vascular Surgery, Sykehuset, Kolding, Denmark
  • Eskilstuna Lasarettet
  • Falu Lasarett Röntgen
  • Helsingborgs Hospital
  • Kalmar County Hospital
  • Karlstad Central Hospital
  • Kristiansund Hospital
  • Lasarett Gävle
  • Lund University Hospital
  • Malmö University
  • Molndal Hospital
  • Region Västmanland
  • Rigshospitalet, Denmark
  • Sahlgrenska University Hospital
  • Sunderbyn Hospital
  • Uppsala University Hospital
  • Vrinnevi Hospital
  • Västervik Hospital

Registry information

Acronym: SCAMICOS

Important dates

Study start
1995
Primary completion
1998
Study completion
1998
First posted
Jan 28, 2011
Registry last updated
Jan 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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