Condition category
Circulatory System
Date applied
23/01/2006
Date assigned
26/05/2006
Last edited
14/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16672699

Publication citations

  1. 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.

Additional files

Editorial Notes