Status:
COMPLETED
Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media
Lead Sponsor:
University Hospital, Saarland
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This was a randomized, placebo-controlled, multi-centre study, double-blind within each dose level, with four ascending dose levels to test the tolerability and safety of iopromide-paclitaxel in patie...
Detailed Description
Background: Non-stent-based immediate release formulations of paclitaxel have been shown to reduce in-stent restenosis in animal experiments and initial clinical trials. Paclitaxel dissolved in the an...
Eligibility Criteria
Inclusion
- male and postmenopausal female patients
- aged 18 years and older
- clinical evidence of stable or unstable angina, a positive functional test and a stentable de novo lesion in a native coronary artery
- diameter stenosis \> 70% (visual estimate), lesion length \< 25 mm, and a vessel diameter ≥ 2.5 mm.
Exclusion
- acute myocardial infarction
- left ventricular ejection fraction of \< 30%
- aorto-ostial lesion
- unprotected left main lesion or a bypass graft
- clear angiographic calcification in the target lesion
- visible thrombus proximal to the lesion
- chronic total occlusion
- platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
- WBC \<3,000 cells/mm3
- known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, stainless steel
- sensitivity to contrast media not amenable to adequate premedication
- medical illness (i.e. cancer, liver disease or congestive heart failure) associated with a life expectancy of less than two years
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01140204
Start Date
March 1 2003
End Date
June 1 2004
Last Update
April 27 2023
Active Locations (2)
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1
University Hospital of Saarland
Homburg/Saar, Saarland, Germany, 66421
2
Charite University Hospital
Berlin, Germany, 10117