ASTRA STUDY (Angioplasty, Stent X-ray Intensive Antithrombotic Therapy) A PHASE III, PROSPECTIVE AND RANDOMIZED, MULTICENTER STUDY, OPEN LABEL, PARALLEL-GROUP, BLINDED ADJUDICATION, TO INVESTIGATE THE EFFECTIVENESS Of BRACHYTHERAPY IN THE REDUCTION OF RESTENOSIS AFTER FEMURAL AND POPLITEAL ARTERIES ANGIOPLASTY WITH OR WITHOUT SELECTIVE STENTING AND/OR INTENSIVE ANTITHROMBOTIC THERAPY IN PATIENTS WITH PERIPHERAL ORGANIC ARTHERY DISEASE OF THE INFERIOR LIMBS (FONTAINE-LERICHE STAGE IIb-IV)
- Conditions
- PAOD (Fontaine-Leriche St. IIb-IV)requiring percutaneous angioplasty with or without stentingMedDRA version: 6.1Level: PTClassification code 10016426
- Registration Number
- EUCTR2005-002251-41-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method