Swedish External Support Study (SWEXSUS)

This study has been completed.
Sponsor:
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
Department of Surgery, Lasarettet, Västervik
Department of Surgery, Lasarettet, Västerås
Department of Surgery, Lasarettet, Växjö
Department of Surgery, Lasarettet, Örebro
Department of Surgery, Lasarettet, Östersund
Information provided by:
University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01273740
First received: January 7, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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 Intervention
Critical Limb Ischemia
Procedure: External support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • primary graft patency [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • limb salvage [ Designated as safety issue: No ]

Enrollment: 334
Study Start Date: January 1995
Study Completion Date: June 1998
Primary Completion Date: June 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Department of Surgery, Lasarettet, Västervik
Department of Surgery, Lasarettet, Västerås
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

No publications provided

Responsible Party: Fredrik Lundgren, Department of CardioVascylar Surgery, Universityhospital, Linköping, Sweden
ClinicalTrials.gov Identifier: NCT01273740     History of Changes
Other Study ID Numbers: SWEXSUS
Study First Received: January 7, 2011
Last Updated: January 7, 2011
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014