- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01140204
Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media
Restenosis Inhibition by Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media
Study Overview
Status
Conditions
Intervention / Treatment
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 angiographic contrast agent iopromide was well tolerated and inhibited neointimal proliferation in a dose-dependent manner after injection into porcine coronary arteries.
Methods: As a first step in entering clinical development, a phase I trial was performed using 4 ascending paclitaxel dose/concentration levels: samples of up to 100 ml of the contrast agent containing 10, 50, 100 or 200 μM paclitaxel were randomly administered to 6 adult patients each assigned to bare metal stent implantation for single de novo coronary artery lesions, while 8 patients treated with plain contrast medium served as controls. Safety variables and tolerability as well as angiographic parameters were assessed.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 10117
- Charité University Hospital
-
-
Saarland
-
Homburg/Saar, Saarland, Germany, 66421
- University Hospital of Saarland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo control
Contrast medium without Paclitaxel
|
Bare Metal Stent
|
Active Comparator: Iopromide Paclitaxel 0.85 mg
|
Bare Metal Stent
|
Active Comparator: Iopromide Paclitaxel 4.27 mg
|
Bare Metal Stent
|
Active Comparator: Iopromide Paclitaxel 8.54 mg
|
Bare Metal Stent
|
Active Comparator: Iopromide Paclitaxel 17.08 mg
|
Bare Metal Stent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of intracoronary application
Time Frame: ca. 30 minutes (during intervention)
|
|
ca. 30 minutes (during intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Late lumen loss
Time Frame: 6 months
|
Difference between angiographic in-stent minimum lumen diameter at 6 months follow-up and post-intervention
|
6 months
|
Restenosis rate
Time Frame: 6 months
|
Defined as a diameter stenosis of ≥50% (assessed by quantitative coronary angiography) at any control angiography
|
6 months
|
Combined clinical endpoints (Major adverse cardiac events, MACE)
Time Frame: 6 months
|
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bruno Scheller, MD, University Hospital, Saarland
- Principal Investigator: Wolfgang Rutsch, MD, Charite Hospital, Berlin
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-325-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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