Balloon angioplasty versus stenting with nitinol stents in the superficial femoral artery
| ISRCTN | ISRCTN52947529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52947529 |
| ClinicalTrials.gov number | NCT00281060 |
| Secondary identifying numbers | EK 164/2003 |
- Submission date
- 23/01/2006
- Registration date
- 26/05/2006
- Last edited
- 14/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Martin Schillinger
Scientific
Scientific
Medical University Vienna
General Hospital Department of Internal Medicine II, Angiology
Waehringer Guertel 18-20
Vienna
A 1090
Austria
| martin.schillinger@meduniwien.ac.at |
Study information
| Study design | 1:1 randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Absolute Trial |
| Study objectives | 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(s) | Approved by the Ethics Committee of the Medical University of Vienna and Vienna General Hospital, reference number: EK 164/2003 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2003 |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 110 patients planned |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 31/07/2005 |
Locations
Countries of recruitment
- Austria
Study participating centre
Medical University Vienna
Vienna
A 1090
Austria
A 1090
Austria
Sponsor information
Medical University Vienna (Austria)
University/education
University/education
c/o Prof Erich Minar
Waehringer Guertel 18-20
Vienna
A 1090
Austria
| Phone | +43 (0)1 40400 4670 |
|---|---|
| martin.schillinger@meduniwien.ac.at | |
"ROR" |
https://ror.org/05n3x4p02 |
Funders
Funder type
University/education
The trial was funded by the Medical University of Vienna and Vienna General Hospital (Austria)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/05/2006 | Yes | No |
