Scandinavian Miller Collar Study

Critical Limb Ischemia Clinical Trial

— SCAMICOS  

Official title:

Scandinavian Miller Collar Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285986
• Other study ID #: SCAMICOS
• Status: Completed
• Phase: N/A
• First received: January 27, 2011
• Last updated: January 27, 2011
• Start date: January 1995
• Est. completion date: June 1998

Study information

• Verified date: January 2011
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: June 1998
• Est. primary completion date: June 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Critical limb ischemia

• Need for bypass surgery

Exclusion Criteria:

• Can not participate in follow-up

• Has suitable saphenous vein

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Limb Ischemia

Intervention

Procedure:
• Vein collar at the distal anastomosis
Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis

Locations

Country	Name	City	State
Sweden	Department of CardioVascular Surgery, University Hospital	Linköping

Sponsors (31)

Lead Sponsor

Collaborator

University Hospital, Linkoeping

Aalborg Universitetshospital, Borås Lasarett, Department of Surgery, Kärnsjukhuset, Skövde, Sweden, Department of Surgery, Lasarettet, Mölndal, Sweden, Department of Surgery, Lasarettet, Motala, Sweden, Department of Surgery, Lasarettet, Norrköping, Sweden, Department of Surgery, Lasarettet, Nyköping, Sweden, Department of Surgery, Lasarettet, Örebro, Sweden, Department of Surgery, Lasarettet, Östersund, Sweden, Department of Surgery, Lasarettet, Skellefteå, Sweden, Department of Surgery, Lasarettet, Växjö, Sweden, Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan-Vänersborg, Sweden, Department of Surgery, S:t Görans Sjukhus, Stockholm, Sweden, Department of Surgery, Södersjukhuset, Stockholm, Sweden, Department of Vascular Surgery, Sykehuset, Kolding, Denmark, Eskilstuna Lasarettet, Falu Lasarett Röntgen, Helsingborgs Hospital, Kalmar County Hospital, Karlstad Central Hospital, Kristiansund Hospital, Landstinget Västmanland, Lasarett Gävle, Lund University Hospital, Malmö University, Rigshospitalet, Denmark, Sahlgrenska University Hospital, Sweden, Sunderbyn Hospital, Uppsala University Hospital, Västervik Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary graft patency	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.	Up to five years	No
Secondary	Secondary Patency	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.	Up to five years	No