Status:
UNKNOWN
Paclitaxel Balloon Versus Standard Balloon in In-stent Restenoses of the Superficial Femoral Artery (PACUBA I Trial)
Lead Sponsor:
Medical University of Vienna
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
PHASE3
Brief Summary
Prospective monocenter single-blind randomized (1:1) investigator sponsored clinical trial, in which consecutive patients candidates for percutaneous intervention of angioplasty to treat symptomatic i...
Detailed Description
Introduction Restenosis after endovascular stenting with nitinol stents occurs in up to 30% of the patients at 12 months and up to 50% at 24 months. The rate of recurrence after repeated treatment of...
Eligibility Criteria
Inclusion
- All criteria 1-6 should apply for inclusion.
- Age \> 50 years
- Patient legally authorized to provide written informed consent
- Patient willing and likely to comply with the follow up schedule
- Patient symptomatic Rutherford-Becker 2-5 (Fontaine II-IV)
- In-stent restenosis in the SFA and P1 segment of the popliteal artery (PA)
- Tibial run-off of at least 1 artery which however may be stenotic but amenable to PTA
Exclusion
- Patients unable to give informed consent
- Patients enrolled in another study with any investigational drug or device
- Major surgical procedures (not including minor amputations) within 30 days prior to this study or planned within 30 days of entry into this study
- Pregnancy
- Patients with any known allergy, hypersensitivity or intolerance to radiologic contrast media, ASA, Clopidogrel or Ticlopidine, Paclitaxel
- Life expectancy of \< 1 years
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01247402
Start Date
November 1 2010
End Date
December 1 2012
Last Update
December 9 2010
Active Locations (2)
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1
Angiology
Vienna, Vienna, Austria, 1090
2
Cardiovascular and Interventional Radiology, AKH-MUW
Vienna, Vienna, Austria, 1090