Status:
UNKNOWN
Drug Coated Balloons for Prevention of Restenosis
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Atherosclerosis
Restenosis
Eligibility:
All Genders
18-95 years
Phase:
PHASE2
PHASE3
Brief Summary
The study will be performed as a randomized, double blind trial (in respect of the primary end point) with treatment of the stenotic lesion using uncoated PTA-catheters as control group. 114 patients ...
Eligibility Criteria
Inclusion
- Age between 18 and 95 years,
- peripheral vascular disease, Rutherford stage 3-5, diameter stenosis ≥ 70 %, ≥ 15 -150 mm length, up to 2 vessels to be treated
Exclusion
- Disease associated with life-expectancy less than 18 months
- Acute thrombus or aneurysm in the index limb/ vessel
- Doubts in the willingness or capability of the patient to allow follow up examination
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00696956
Start Date
April 1 2008
End Date
April 1 2011
Last Update
June 13 2008
Active Locations (5)
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1
Herzzentrum Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, Germany, 76551
2
University of Tuebingen
Tübingen, Baden-Wurttemberg, Germany, 72076
3
Charite Berlin
Berlin, B, Germany, 10001
4
Jüdisches Krankenhaus Berlin
Berlin, B, Germany, 10001