Status:
COMPLETED
Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter
Lead Sponsor:
University Hospital, Saarland
Conditions:
In-stent Arterial Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.
Detailed Description
Prospective, controlled, multicenter, randomized, single-blind trial. The aim is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon. Patien...
Eligibility Criteria
Inclusion
- \>18 years of age
- clinical evidence of stable or unstable angina or a positive functional study
- patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis) within previously placed bare metal stents (BMS)
Exclusion
- acute myocardial infarction within the past 72 hours
- chronic renal insufficiency with serum creatinine levels \>2.0 mg per deciliter%
- known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or paclitaxel, and sensitivity to contrast media not amenable to premedication
- concomitant medical illness associated with a life-expectancy of less than two years
- stented segment length ≥30 mm, vessel diameter \<2.5 mm, diameter stenosis \<70%
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01495533
Start Date
December 1 2011
End Date
July 1 2014
Last Update
April 27 2023
Active Locations (3)
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1
Danta Pazzanese Heart Institute
São Paulo, Brazil
2
Internal Medicine III, UKS
Homburg Saar, Germany, 66421
3
Herzzentrum Leipzig
Leipzig, Germany