Scandinavian Miller Collar Study (SCAMICOS)

This study has been completed.

Sponsor:

Collaborators:

Sunderbyn Hospital

Borås Lasarett

Eskilstuna Lasarettet

Falu Lasarett Röntgen

Sahlgrenska University Hospital, Sweden

Lasarett Gävle

Helsingborgs Hospital

Kalmar County Hospital

Karlstad Central Hospital

Kristiansund Hospital

Lund University Hospital

Malmö University

Department of Surgery, Lasarettet, Motala, Sweden

Department of Surgery, Lasarettet, Mölndal, Sweden

Department of Surgery, Lasarettet, Norrköping, Sweden

Department of Surgery, Lasarettet, Nyköping, Sweden

Department of Surgery, Lasarettet, Skellefteå, Sweden

Department of Surgery, Kärnsjukhuset, Skövde, Sweden

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

Department of Surgery, Södersjukhuset, Stockholm, Sweden

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

Uppsala University Hospital

Västervik Hospital

Landstinget Västmanland

Department of Surgery, Lasarettet, Växjö, Sweden

Department of Surgery, Lasarettet, Örebro, Sweden

Department of Surgery, Lasarettet, Östersund, Sweden

Department of Vascular Surgery, Sykehuset, Kolding, Denmark

Rigshospitalet, Denmark

Aalborg Universitetshospital

Information provided by:

University Hospital, Linkoeping

ClinicalTrials.gov Identifier:

NCT01285986

First received: January 27, 2011

Last updated: NA

Last verified: January 2011

History: No changes posted

Purpose

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

Condition	Intervention
Critical Limb Ischemia	Procedure: Vein collar at the distal anastomosis


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Scandinavian Miller Collar Study

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:

Primary graft patency [ Time Frame: Up to five years ] [ Designated as safety issue: No ]
Follow-up at 1, 3, 6, and 12. Thereafter at most 5 years or until death of patient or amputation of limb. Primary graft patency = patent graft without any intervention to open up or prevent a graft ocklusion. Methods used for verification of patency: angiography, duplex, an improved ankle-brachial index was mantained, palpable pulse, or bi- or triphasic Doppler signal over the graft.

Secondary Outcome Measures:

Secondary Patency [ Time Frame: Up to five years ] [ Designated as safety issue: No ]
Secondary patency = patent graft after one or several interventions to open up or prevent a graft occlusion. Methods used for verification of secondary patency: angiography, duplex, an improved ankle-brachial index was mantained, palpable pulse, or bi- or triphasic Doppler signal over the graft.


Enrollment:	352
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: Vein collar at distal anastomosis Vein collar at the distal anastomosis	Procedure: Vein collar at the distal anastomosis Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis
Experimental: No vein collar at the distal anastomosis No vein collar at the distal anastomosis	Procedure: Vein collar at the distal anastomosis Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis

Eligibility


Ages Eligible for Study:	20 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Critical limb ischemia
Need for bypass surgery

Exclusion Criteria:

Can not 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: NCT01285986

Locations


Sweden
Department of CardioVascular Surgery, University Hospital
Linköping, Sweden, 581 85

Sponsors and Collaborators