Scandinavian Miller Collar Study

NCT ID: NCT01285986

Last Updated: 2011-01-28

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

352 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 a vein collar at the distal anastomosis 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

Keywords

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Graft patency Limb salvage

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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Vein collar at distal anastomosis

Vein collar at the distal anastomosis

Group Type EXPERIMENTAL

Vein collar at the distal anastomosis

Intervention Type PROCEDURE

Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis

No vein collar at the distal anastomosis

No vein collar at the distal anastomosis

Group Type EXPERIMENTAL

Vein collar at the distal anastomosis

Intervention Type PROCEDURE

Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis

Interventions

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Vein collar at the distal anastomosis

Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Critical limb ischemia
* Need for bypass surgery

Exclusion Criteria

* Can not 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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Sunderbyn Hospital

OTHER

Sponsor Role collaborator

Borås Lasarett

OTHER

Sponsor Role collaborator

Eskilstuna Lasarettet

OTHER

Sponsor Role collaborator

Falu Lasarett Röntgen

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

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, Sweden

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Lasarettet, Mölndal, Sweden

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Lasarettet, Norrköping, Sweden

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Lasarettet, Nyköping, Sweden

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Lasarettet, Skellefteå, Sweden

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Kärnsjukhuset, Skövde, Sweden

UNKNOWN

Sponsor Role collaborator

Department of Surgery, S:t Görans Sjukhus, Stockholm, Sweden

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Södersjukhuset, Stockholm, Sweden

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan-Vänersborg, Sweden

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, Sweden

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Lasarettet, Örebro, Sweden

UNKNOWN

Sponsor Role collaborator

Department of Surgery, Lasarettet, Östersund, Sweden

UNKNOWN

Sponsor Role collaborator

Department of Vascular Surgery, Sykehuset, Kolding, Denmark

UNKNOWN

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role lead

Principal Investigators

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Fredrik BG Lundgren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Surgery, University Hospital, Linköping, Sweden

Locations

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Department of CardioVascular Surgery, University Hospital

Linköping, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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SCAMICOS

Identifier Type: -

Identifier Source: org_study_id