Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-29 @ 1:01 AM
Study NCT ID:
NCT01140204
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2010-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2010-06-07', 'studyFirstSubmitQcDate': '2010-06-08', 'lastUpdatePostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of intracoronary application', 'timeFrame': 'ca. 30 minutes (during intervention)', 'description': '* Continuous monitoring electrocardiogram (ECG)\n* Vital signs\n* Invasive measure of blood pressure\n* Lab variables: red blood count, white blood count, diff, creatinine kinase, creatinine kinase - muscle bound, creatinine\n* Cmax of paclitaxel in serum\n* 12-lead ECG\n* Adverse events'}], 'secondaryOutcomes': [{'measure': 'Late lumen loss', 'timeFrame': '6 months', 'description': 'Difference between angiographic in-stent minimum lumen diameter at 6 months follow-up and post-intervention'}, {'measure': 'Restenosis rate', 'timeFrame': '6 months', 'description': 'Defined as a diameter stenosis of ≥50% (assessed by quantitative coronary angiography) at any control angiography'}, {'measure': 'Combined clinical endpoints (Major adverse cardiac events, MACE)', 'timeFrame': '6 months', 'description': '1. Abrupt and sub-abrupt closure\n2. Target lesion revascularization\n3. Myocardial infarction\n4. Death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stent', 'contrast media', 'paclitaxel', 'stent implantation'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': '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 patients with de novo lesions in coronary arteries. Thirty-two patients were included into the trial, which were divided into four treatment groups. A total of four concentration levels of paclitaxel-iopromide concentrations were investigated. In each treatment group, six patients received iopromide-paclitaxel and two patients placebo (iopromide without paclitaxel). In each patient, the doses were adjusted individually as needed.', 'detailedDescription': '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.\n\nMethods: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and postmenopausal female patients\n* aged 18 years and older\n* clinical evidence of stable or unstable angina, a positive functional test and a stentable de novo lesion in a native coronary artery\n* diameter stenosis \\> 70% (visual estimate), lesion length \\< 25 mm, and a vessel diameter ≥ 2.5 mm.\n\nExclusion Criteria:\n\n* acute myocardial infarction\n* left ventricular ejection fraction of \\< 30%\n* aorto-ostial lesion\n* unprotected left main lesion or a bypass graft\n* clear angiographic calcification in the target lesion\n* visible thrombus proximal to the lesion\n* chronic total occlusion\n* platelet count \\<100,000 cells/mm3 or \\>700,000 cells/mm3\n* WBC \\<3,000 cells/mm3\n* known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, stainless steel\n* sensitivity to contrast media not amenable to adequate premedication\n* medical illness (i.e. cancer, liver disease or congestive heart failure) associated with a life expectancy of less than two years'}, 'identificationModule': {'nctId': 'NCT01140204', 'briefTitle': 'Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Restenosis Inhibition by Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media', 'orgStudyIdInfo': {'id': '1-325-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo control', 'description': 'Contrast medium without Paclitaxel', 'interventionNames': ['Device: Implantation of a bare metal stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Iopromide Paclitaxel 0.85 mg', 'description': 'Iopromide Paclitaxel 0.85 mg', 'interventionNames': ['Device: Implantation of a bare metal stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Iopromide Paclitaxel 4.27 mg', 'description': 'Iopromide Paclitaxel 4.27 mg', 'interventionNames': ['Device: Implantation of a bare metal stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Iopromide Paclitaxel 8.54 mg', 'description': 'Iopromide Paclitaxel 8.54 mg', 'interventionNames': ['Device: Implantation of a bare metal stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Iopromide Paclitaxel 17.08 mg', 'description': 'Iopromide Paclitaxel 17.08 mg', 'interventionNames': ['Device: Implantation of a bare metal stent']}], 'interventions': [{'name': 'Implantation of a bare metal stent', 'type': 'DEVICE', 'description': 'Bare Metal Stent', 'armGroupLabels': ['Iopromide Paclitaxel 0.85 mg', 'Iopromide Paclitaxel 17.08 mg', 'Iopromide Paclitaxel 4.27 mg', 'Iopromide Paclitaxel 8.54 mg', 'Placebo control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg/Saar', 'state': 'Saarland', 'country': 'Germany', 'facility': 'University Hospital of Saarland'}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite University Hospital', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Bruno Scheller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Saarland'}, {'name': 'Wolfgang Rutsch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite Hospital, Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Saarland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}