Contact information
Type
Scientific
Primary contact
Dr Martin Schillinger
ORCID ID
Contact details
Medical University Vienna
General Hospital Department of Internal Medicine II
Angiology
Waehringer Guertel 18-20
Vienna
A 1090
Austria
martin.schillinger@meduniwien.ac.at
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00281060
Protocol/serial number
EK 164/2003
Study information
Scientific title
Acronym
Absolute Trial
Study hypothesis
Primary stenting with self-expanding nitinol stents may improve patency after endovascular treatment of superficial femoral artery obstructions compared to balloon angioplasty with optional stenting
Ethics approval
Approved by the Ethics Committee of the Medical University of Vienna and Vienna General Hospital, reference number: EK 164/2003
Study design
1:1 randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Peripheral artery disease, superficial femoral artery stenosis or occlusion
Intervention
Group 1: primary stenting
Group 2: Percutaneous transluminal angioplasty (PTA) (balloon angioplasty) with optional secondary stenting
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Angiographic restenosis at six months
Secondary outcome measures
1. Restenosis by duplex ultrasound at 3, 6 and 12 months
2. Walking distance on the treadmill at 3, 6 and 12 months
3. Ankle brachial index at 3, 6 and 12 months
4. Stent fractures at 6 and 12 months
Overall trial start date
01/06/2003
Overall trial end date
31/07/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Symptomatic peripheral artery disease - Rutherford stages 3 to 5
2. >50% Stenosis of the ipsilateral superficial femoral artery
3. Lesion length >30 mm
4. At least one patent crural runoff vessel
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
110 patients planned
Participant exclusion criteria
1. Acute critical limb ischemia
2. Previous ipsilateral bypass surgery or ipsilateral superficial femoral artery (SFA) stenting
3. Untreated inflow disease
4. Known intolerance to clopidogrel, aspirin or radiocontrast
Recruitment start date
01/06/2003
Recruitment end date
31/07/2005
Locations
Countries of recruitment
Austria
Trial participating centre
Medical University Vienna
Vienna
A 1090
Austria
Sponsor information
Organisation
Medical University Vienna (Austria)
Sponsor details
c/o Prof Erich Minar
Waehringer Guertel 18-20
Vienna
A 1090
Austria
+43 (0)1 40400 4670
martin.schillinger@meduniwien.ac.at
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
The trial was funded by the Medical University of Vienna and Vienna General Hospital (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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16672699
Publication citations
-
Results
Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E, Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery., N. Engl. J. Med., 2006, 354, 18, 1879-1888, doi: 10.1056/NEJMoa051303.