NCT01285986

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 1995

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1995

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1998

Completed
12.7 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2011

Completed
Last Updated

January 28, 2011

Status Verified

January 1, 2011

Enrollment Period

3.4 years

First QC Date

January 27, 2011

Last Update Submit

January 27, 2011

Conditions

Critical Limb Ischemia

Keywords

Graft patencyLimb salvage

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Secondary Patency

    Up to five years

Study Arms (2)

Vein collar at distal anastomosis

EXPERIMENTAL

Vein collar at the distal anastomosis

Procedure: Vein collar at the distal anastomosis

No vein collar at the distal anastomosis

EXPERIMENTAL

No vein collar at the distal anastomosis

Procedure: Vein collar at the distal anastomosis

Interventions

Vein collar at the distal anastomosisPROCEDURE

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

No vein collar at the distal anastomosisVein collar at distal anastomosis

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Critical limb ischemia
  • Need for bypass surgery

You may not qualify if:

  • Can not participate in follow-up
  • Has suitable saphenous vein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of CardioVascular Surgery, University Hospital

Linköping, 581 85, Sweden

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • Fredrik BG Lundgren, MD, PhD

    Department of Cardiovascular Surgery, University Hospital, Linköping, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2011

First Posted

January 28, 2011

Study Start

January 1, 1995

Primary Completion

June 1, 1998

Study Completion

June 1, 1998

Last Updated

January 28, 2011

Record last verified: 2011-01

Locations

SE(1)