Swedish External Support Study

NCT ID: NCT01273740

Last Updated: 2011-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-01-31

Study Completion Date

1998-06-30

Brief Summary

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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

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Conditions

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Critical Limb Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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External support

Bypass graft with external support

Group Type EXPERIMENTAL

External support

Intervention Type PROCEDURE

Bypass surgery with externally supported graft

No external support

Bypass with graft without external support

Group Type EXPERIMENTAL

External support

Intervention Type PROCEDURE

Bypass surgery with externally supported graft

Interventions

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External support

Bypass surgery with externally supported graft

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Critical limb ischemia Need for bypass surgery

Exclusion Criteria

Can participate in follow-up Has suitable saphenous vein
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lasarettet Boden

OTHER

Sponsor Role collaborator

Borås Lasarett

OTHER

Sponsor Role collaborator

Eskilstuna Lasarettet

OTHER

Sponsor Role collaborator

Falu Lasarett Röntgen

OTHER

Sponsor Role collaborator

Department of Surgery, Sahlgrenska sjukhuset, Göteborg

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Östra sjukhuset, Göteborg

UNKNOWN

Sponsor Role collaborator

Lasarett Gävle

OTHER

Sponsor Role collaborator

Helsingborgs Hospital

OTHER

Sponsor Role collaborator

Kalmar County Hospital

OTHER

Sponsor Role collaborator

Karlstad Central Hospital

OTHER

Sponsor Role collaborator

Kristiansund Hospital

OTHER

Sponsor Role collaborator

Lund University Hospital

OTHER

Sponsor Role collaborator

Malmö University

OTHER

Sponsor Role collaborator

Department of Surgery, Lasarettet, Motala

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Lasarettet, Mölndal

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Lasarettet, Norrköping

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Lasarettet, Nyköping

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Lasarettet, Skellefteå

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Kärnsjukhuset, Skövde

UNKNOWN

Sponsor Role collaborator

Department of Surgery, S:t Görans Sjukhus, Stockholm

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Södersjukhuset, Stockholm

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan-Vänersborg

UNKNOWN

Sponsor Role collaborator

Uppsala University Hospital

OTHER

Sponsor Role collaborator

Västervik Hospital

OTHER

Sponsor Role collaborator

Region Västmanland

OTHER

Sponsor Role collaborator

Department of Surgery, Lasarettet, Växjö

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Lasarettet, Örebro

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Lasarettet, Östersund

UNKNOWN

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Department of CardioVascylar Surgery, Universityhospital, Linköping, Sweden

Principal Investigators

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Fredrik BG Lundgren, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Department of CardioVascular Surgery, University Hospital, Linköping, Sweden

Other Identifiers

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SWEXSUS

Identifier Type: -

Identifier Source: org_study_id

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