Condition category
Circulatory System
Date applied
12/05/2013
Date assigned
04/09/2013
Last edited
12/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Relief of peripheral arterial occlusive disease (a narrowing of the blood vessels commonly seen in the legs sometimes seen in the arms) can be achieved either by open surgical interventions or minimally invasive percutaneous interventions (a medical procedure where access to inner organs or other tissue is done through a needle-puncture of the skin). The groin artery is a difficult artery to deal with, especially due to its location, and open surgery, although durable, can lead to long-lasting wound healing problems. Stent (a small mesh tube) implantation in that region has long been avoided, due to the fact that stents may be deformed, and later access for open and endovascular interventions (surgery that accesses regions inside the body via major blood vessels) may be difficult. A bioabsorbable stent may overcome these problems, as it dissolves within a defined time period (8 months), thus leaving the artery without foreign body, and accessible for open surgery and percutaneous intervention.

Who can participate?
Patients with peripheral arterial occlusive disease in the common femoral artery (artery in the thigh) due to thickening of the artery wall (atherosclerosis).

What does the study involve?
Patients requiring a common femoral artery intervention will be randomly allocated after informed consent into one of the two arms: open surgery or stent placement.

What are the possible benefits and risks of participating?
Both procedures are performed routinely at the department, there are no special risks involved for the patients taking part in this trial.

Where is the study run from?
Paracelsus Medical University, Austria.

When is the study starting and how long is it expected to run for?
The study started in May 2011 and will run until January 2017.

Who is funding the study?
Kyoto Medical planning.

Who is the main contact?
Prof Thomas Hölzenbein

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Hölzenbein

ORCID ID

Contact details

Department of Vascular and Endovascular Surgery
PMU Salzburg
Müllner Hauptstrasse 48
Salzburg
A-5020
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Bioabsorbable stent implantation versus endarterectomy for atherosclerotic lesions in the common femoral artery: an open prospective randomized trial

Acronym

Study hypothesis

Stent implantation in the femoral artery is an accepted treatment for short atherosclerotic lesions. It is minimally invasive, and can be done under local anesthesia with very short hospital stay. Yet stent implantation in the groin artery carries the risk for stent deformation and subsequent stent failure. Surgery is more durable, yet more invasive, and carries more perioperative complications (infection, bleeding). Our study hypothesis is that, a bioabsorbable stent may overcome the disadvantages of stent deformation, and will not impede later endovascular or open surgery of the groin artery because the stent dissolves within 8 months. Therefore, stent treatment with a bioabsorbable stent may become a better therapeutic option than open surgery.

On 28/01/2014 the overall trial start date was changed from 01/01/2013 to 01/05/2011.

On 13/11/2014 the target number of participants was changed from 120 (60 per group) to 214 (107 per group).

Ethics approval

Local research ethics committee, PMU Salzburg, Austria, 16/09/2013, ref: 415-E/1657/3-2013

Study design

Open prospective randomized trial

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

Atherosclerosis. Peripheral arterial occlusive disease. Fontaine stages IIb-IV

Intervention

1. Standard common femoral artery endarterectomy with patch closure (vein/artificial)
2. Percutaneous common femoral artery stent implantation using a bioabsorbable lactic acid stent

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Current primary outcome measures as of 28/01/2014:
1. Surgical site infections (SSI, local groin complications associated with intervention, i.e. wound healing, bleeding, infection)

Outcomes are measured regularly at baseline, one month, 3 months, 6 months and biannually thereafter

Previous primary outcome measures:
1. Intervention patency
2. Effect of intervention (improvement of circulation as measuerd by the ankle/brachial index)
3. Limb salvage
4. Survival

Outcomes are measured regularly at baseline, 1 month, 3 months, 6 months and biannually thereafter

Secondary outcome measures

Current secondary outcome measures as of 28/01/2014:
1. Technical success
2. Hemodynamic improvement (measured by ankle-brachial index)
3. Primary sustained clinical improvement (relief of symptoms measured by standard forms, e.g. SF19)
4. Secondary sustained clinical improvement (relief of symptoms measured by standard forms, e.g. SF19)
5. Patency
6. Limb salvage
7. Hospital resource use (length of stay, outpatient clinic visits, costs)
8. Survival

Outcomes are measured regularly at baseline, 1 month, 3 months, 6 months and biannually thereafter

Previous secondary outcome measures:
1. Local groin complications associated with intervention (wound healing, bleeding, infection)
2. Relief of symptoms (measured by standard forms e.g. SF19)
3. Hospital resource use (length of stay, outpatient clinic visits, costs)
4. Secondary intervention for improvement of circulation

Outcomes are measured regularly at baseline, 1 month, 3 months, 6 months and biannually thereafter

Overall trial start date

01/05/2011

Overall trial end date

31/01/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with peripheral arterial occlusive disease in the common femoral artery due to atheroscloerosis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

214 (107 per group)

Participant exclusion criteria

1. Pregnancy
2. Active malignancy
3. Infectious diseases (hepatitis, HIV)
4. Inability to comply with study requirements (e.g. regular follow up)

Recruitment start date

01/05/2011

Recruitment end date

31/01/2017

Locations

Countries of recruitment

Austria

Trial participating centre

PMU Salzburg
Salzburg
A-5020
Austria

Sponsor information

Organisation

Paracelsus Medical University (PMU) (Paracelsus Medizinische Privatuniversität) (Austria)

Sponsor details

c/o Prof Thomas Hölzenbein
Department of Vascular and Endovascular Surgery
Müllner Hauptstrasse 48
Salzburg
A-5020
Austria

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Kyoto Medical planning (An insurance regarding adverse outcomes) (Japan)

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25101576

Publication citations

Additional files

Editorial Notes