Arm veins versus contralateral greater saphenous vein for lower extremity bypass reconstruction in patients with absent ipsilateral greater saphenous vein

ISRCTN ISRCTN25666105
DOI https://doi.org/10.1186/ISRCTN25666105
Secondary identifying numbers N/A
Submission date
13/01/2014
Registration date
12/02/2014
Last edited
24/01/2019
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Thomas Hölzenbein
Scientific

Müllner Hauptstrasse 48
Salzburg
5020
Austria

Email t.hoelzenbein@salk.at

Study information

Study designOpen randomized study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleArm veins versus contralateral greater saphenous vein for lower extremity bypass reconstruction in patients with absent ipsilateral greater saphenous vein: a randomized trial
Study objectivesArm 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(s)Local Research Ethics Committee, PMU Salzburg, Austria, 30/10/2013, ref.: 415-E/1690/2-2013
Health condition(s) or problem(s) studiedPeripheral arterial occlusive disease of the lower extremity
InterventionStandard 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 typeOther
Primary outcome measurePrimary 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 measures1. 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 study start date01/06/2010
Completion date01/06/2016
Reason abandoned (if study stopped)Technical reasons

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants628
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/06/2010
Date of final enrolment01/06/2016

Locations

Countries of recruitment

  • Austria

Study participating centre

Müllner Hauptstrasse 48
Salzburg
5020
Austria

Sponsor information

Paracelsus Medical University (PMU) (Austria)
Hospital/treatment centre

Müllner Hauptstrasse 48
Salzburg
5020
Austria

Email t.hoelzenbein@salk.at
ROR logo "ROR" https://ror.org/03z3mg085

Funders

Funder type

Government

Salzburg State Clinics (Salzburger Landeskliniken) (SALK) (Austria)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

24/01/2019: Study abandoned