Plain English Summary
Background and study aims
Patients suffering from peripheral arterial occlusive disease of the leg (narrowing of the arteries due to accumulation of fatty substances, such as cholesterol) need bypass surgery of the leg to avoid amputation. It is well known that the ipsilateral greater saphenous vein (the vein of the leg which has to be treated) is the best material for bypass reconstruction. In cases where the ipsilateral GSV is missing (due to a former bypass operation, vein stripping operation, trauma, etc), alternative bypass graft material has to be used, either autologous graft material (derived or transferred from the same person's body) or artificial graft material. Artificial graft materials have the disadvantage of significantly shorter patency rates (i.e., reduced likelihood that the vein will remain open), especially for below knee procedures, compared to autologous bypasses. Additionally, artificial grafts may have devastating effects for the patient in cases of graft infection. Autologous options in case of absent ipsilateral GSV are arm veins (basilic vein, cephalic vein), GSV of the contralateral (other) leg not undergoing bypass, or the lesser saphenous vein. The lesser saphenous vein (superficial vein of the calf) would be a reasonable alternative in case of absent ipsilateral GSV but is usually too short for below knee bypass reconstructions. Therefore, contralateral GSV and arm veins are the best bypass graft options for lower extremity revascularisation in case of absent ipsilateral GSV. The aim of this study is to assess the effectiveness and outcome of patients without ipsilateral GSV undergoing lower extremity bypass surgery using either arm veins (basilic vein and/or cephalic vein, Group A) or contralateral GSV (Group B).
Who can participate?
Men and women aged 30 years and older with peripheral arterial occlusive disease due to atherosclerosis.
What does the study involve?
Patients with absent ipsilateral GSV needing lower extremity bypass reconstruction are randomly allocated to Group A (arm vein bypass graft) or Group B (contralateral GSV bypass graft).
What are the possible benefits and risks of participating?
Patients taking part in the study will not directly benefit. Future patients will benefit because the study should show if the arm vein or the contralateral greater saphenous vein is the best choice.
Both procedures are performed routinely at our department. There are no special risks involved for the patients taking part in the study.
Where is the study run from?
Paracelsus Medical University (PMU), Salzburg, Austria.
When is the study starting and how long is it expected to run for?
The study started in June 2010 and will run until June 2016.
Who is funding the study?
Salzburg State Clinics (Salzburger Landeskliniken) (SALK) (Austria).
Who is the main contact?
Prof. Thomas Hölzenbein
t.hoelzenbein@salk.at
Trial website
Contact information
Type
Scientific
Primary contact
Prof Thomas Hölzenbein
ORCID ID
Contact details
Müllner Hauptstrasse 48
Salzburg
5020
Austria
-
t.hoelzenbein@salk.at
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Arm veins versus contralateral greater saphenous vein for lower extremity bypass reconstruction in patients with absent ipsilateral greater saphenous vein: a randomized trial
Acronym
Study hypothesis
Arm veins do better regarding bypass patency compared to contralateral greater saphenous vein (superficial vein of the contralateral leg) in patients needing lower extremity bypass surgery in case of absent ipsilateral greater saphenous vein (superficial vein of the leg which has to be treated).
The null hypothesis is that there will be no difference between arm veins and contralateral greater saphenous vein regarding bypass patency.
On 11/06/2014 the target number of participants was changed from 100 to 628.
Ethics approval
Local Research Ethics Committee, PMU Salzburg, Austria, 30/10/2013, ref.: 415-E/1690/2-2013
Study design
Open randomized study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Peripheral arterial occlusive disease of the lower extremity
Intervention
Standard vein bypass techniques for lower limb revascularization in patients suffering from peripheral arterial occlusive disease.
For Group A patients arm veins (basilic and/or cephalic vein) are harvested and used as bypass graft
For Group B patients the contralateral greater saphenous vein is harvested and used for bypass reconstruction
Follow-up duration: 2 years
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Primary and secondary bypass patency measured at baseline, 1 month, 3 months , 6 months after discharge and then at 6-month intervals for 2 years
Secondary outcome measures
1. Local complications (e.g., surgical site infections)
2. Systemic complications (e.g., myocardial infarction, stroke)
3. Clinical and hemodynamic improvement
4. Limb salvage
5. Survival
Measured at baseline, 1 month, 3 months , 6 months after discharge and then at 6-month intervals for 2 years.
Overall trial start date
01/06/2010
Overall trial end date
01/06/2016
Reason abandoned (if study stopped)
Technical reasons
Eligibility
Participant inclusion criteria
1. Male or female aged 30 years and over
2. Claudication > 2 months
3. Critical leg ischemia > 2 months
4. Popliteal aneurysm
5. Absent ipsilateral greater saphenous vein
6. Usable arm vein (cephalic and/or basilic vein without signs of sclerosis or thrombosis and with diameter > 2.5 mm verified by preoperative duplex)
7. Usable contralateral greater saphenous vein (without signs of sclerosis or thrombosis and with diameter > 2.5 mm verified by preoperative duplex)
8. Atherosclerosis
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
628
Participant exclusion criteria
1. Urgent critical leg ischemia (thromboembolic event < 2 months)
2. Absent arm vein (e.g., due to prior operation)
3. Unusable arm vein (due to sclerosis and/or thrombosis and/or small (< 2.5 mm) diameter verified by preoperative duplex)
4. Absent contralateral greater saphenous vein (due to prior coronary bypass, peripheral bypass, vein stripping, trauma, etc)
5. Unusable contralateral greater saphenous vein (due to sclerosis and/or thrombosis and/or small (< 2.5 mm) diameter verified by duplex)
6. Arm veins should be saved for arterio-venous fistula
7. Deep vein thrombosis of the contralateral leg
8. Critical leg ischemia of the contralateral leg
9. Trauma
Recruitment start date
01/06/2010
Recruitment end date
01/06/2016
Locations
Countries of recruitment
Austria
Trial participating centre
Müllner Hauptstrasse 48
Salzburg
5020
Austria
Sponsor information
Organisation
Paracelsus Medical University (PMU) (Austria)
Sponsor details
Müllner Hauptstrasse 48
Salzburg
5020
Austria
-
t.hoelzenbein@salk.at
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Salzburg State Clinics (Salzburger Landeskliniken) (SALK) (Austria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list