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Swedish External Support Study (SWEXSUS)

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ClinicalTrials.gov Identifier: NCT01273740
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : January 10, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
Randomized study to evaluate the effect of adding external support 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.

Condition or disease Intervention/treatment
Critical Limb Ischemia Procedure: External support

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Swedish External Support Study is Randomized Trial of the Effect of External Support of PTFE-grafts for Bypass to Below Knee Arteries.
Study Start Date : January 1995
Primary Completion Date : June 1998
Study Completion Date : June 1998
Arms and Interventions

Arm Intervention/treatment
Experimental: External support
Bypass graft with external support
Procedure: External support
Bypass surgery with externally supported graft
Experimental: No external support
Bypass with graft without external support
Procedure: External support
Bypass surgery with externally supported graft


Outcome Measures

Primary Outcome Measures :
  1. primary graft patency

Secondary Outcome Measures :
  1. limb salvage

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Critical limb ischemia Need for bypass surgery

Exclusion Criteria:

Can participate in follow-up Has suitable saphenous vein

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273740


Sponsors and Collaborators
University Hospital, Linkoeping
Lasarettet Boden
Borås Lasarett
Eskilstuna Lasarettet
Falu Lasarett Röntgen
Department of Surgery, Sahlgrenska sjukhuset, Göteborg
Department of Surgery, Östra sjukhuset, Göteborg
Lasarett Gävle
Helsingborgs Hospital
Kalmar County Hospital
Karlstad Central Hospital
Kristiansund Hospital
Lund University Hospital
Malmö University
Department of Surgery, Lasarettet, Motala
Department of Surgery, Lasarettet, Mölndal
Department of Surgery, Lasarettet, Norrköping
Department of Surgery, Lasarettet, Nyköping
Department of Surgery, Lasarettet, Skellefteå
Department of Surgery, Kärnsjukhuset, Skövde
Department of Surgery, S:t Görans Sjukhus, Stockholm
Department of Surgery, Södersjukhuset, Stockholm
Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan-Vänersborg
Uppsala University Hospital
Västervik Hospital
Region Västmanland
Department of Surgery, Lasarettet, Växjö
Department of Surgery, Lasarettet, Örebro
Department of Surgery, Lasarettet, Östersund
Investigators
Principal Investigator: Fredrik BG Lundgren, PhD, MD Department of CardioVascular Surgery, University Hospital, Linköping, Sweden
More Information

Responsible Party: Fredrik Lundgren, Department of CardioVascylar Surgery, Universityhospital, Linköping, Sweden
ClinicalTrials.gov Identifier: NCT01273740     History of Changes
Other Study ID Numbers: SWEXSUS
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: January 2011

Keywords provided by University Hospital, Linkoeping:
PTFE bypass
femoro-popliteal
femoro-crural
popliteal arteries
crural arteries
external support
crtical limb ischemia

Additional relevant MeSH terms:
Ischemia
Pathologic Processes