Swedish External Support Study (SWEXSUS)
This study has been completed.
Sponsor:
University Hospital, Linkoeping
Collaborators:
Department of Surgery, Lasarettet, Boden
Department of Surgery, Lasarettet, Borås
Department of Surgery, Lasarettet, Eskilstuna
Department of Surgery, Lasarettet, Falun
Department of Surgery, Sahlgrenska sjukhuset, Göteborg
Department of Surgery, Östra sjukhuset, Göteborg
Department of Surgery, Lasarettet, Gävle
Department of Surgery, Lasarettet, Helsingborg
Department of Surgery, Lasarettet, Kalmar
Department of Surgery, Lasarettet, Karlstad
Department of Surgery, Lasarettet, Kristianstad
Department of Vascular Surgery, Universitetssjukhuset, Linköping
Department of Surgery, Universitetssjukhuset, Lund
Department of Surgery, Universitetssjukhuset, Malmö
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273740
Sponsors and Collaborators
University Hospital, Linkoeping
Department of Surgery, Lasarettet, Boden
Department of Surgery, Lasarettet, Borås
Department of Surgery, Lasarettet, Eskilstuna
Department of Surgery, Lasarettet, Falun
Department of Surgery, Sahlgrenska sjukhuset, Göteborg
Department of Surgery, Östra sjukhuset, Göteborg
Department of Surgery, Lasarettet, Gävle
Department of Surgery, Lasarettet, Helsingborg
Department of Surgery, Lasarettet, Kalmar
Department of Surgery, Lasarettet, Karlstad
Department of Surgery, Lasarettet, Kristianstad
Department of Vascular Surgery, Universitetssjukhuset, Linköping
Department of Surgery, Universitetssjukhuset, Lund
Department of Surgery, Universitetssjukhuset, Malmö
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 May 16, 2013