Swedish External Support Study (SWEXSUS)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01273740

First Posted: January 10, 2011

Last Update Posted: January 10, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

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

Landstinget Västmanland

Department of Surgery, Lasarettet, Växjö

Department of Surgery, Lasarettet, Örebro

Department of Surgery, Lasarettet, Östersund

Information provided by:

University Hospital, Linkoeping

Tracking Information

First Submitted Date ^ICMJE

January 7, 2011

First Posted Date ^ICMJE

January 10, 2011

Last Update Posted Date

January 10, 2011

Start Date ^ICMJE

January 1995

Primary Completion Date

June 1998 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

primary graft patency

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

limb salvage

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Swedish External Support Study

Official Title ^ICMJE

Swedish External Support Study is Randomized Trial of the Effect of External Support of PTFE-grafts for Bypass to Below Knee Arteries.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Critical Limb Ischemia

Intervention ^ICMJE

Procedure: External support

Bypass surgery with externally supported graft

Study Arms

Experimental: External support
Bypass graft with external support

Intervention: Procedure: External support
Experimental: No external support
Bypass with graft without external support

Intervention: Procedure: External support

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

334

Completion Date

June 1998

Primary Completion Date

June 1998 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Critical limb ischemia Need for bypass surgery

Exclusion Criteria:

Can participate in follow-up Has suitable saphenous vein

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01273740

Other Study ID Numbers ^ICMJE

SWEXSUS

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Fredrik Lundgren, Department of CardioVascylar Surgery, Universityhospital, Linköping, Sweden

Study Sponsor ^ICMJE

University Hospital, Linkoeping

Collaborators ^ICMJE

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
Landstinget Västmanland
Department of Surgery, Lasarettet, Växjö
Department of Surgery, Lasarettet, Örebro
Department of Surgery, Lasarettet, Östersund

Investigators ^ICMJE

Principal Investigator:

Fredrik BG Lundgren, PhD, MD

Department of CardioVascular Surgery, University Hospital, Linköping, Sweden

PRS Account

University Hospital, Linkoeping

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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