Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT01081366
Status:
COMPLETED
Last Update Posted:
2016-01-22
First Post:
2010-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Eluting Pantera Lux Catheter Registry
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1064}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-21', 'studyFirstSubmitDate': '2010-03-04', 'studyFirstSubmitQcDate': '2010-03-04', 'lastUpdatePostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Events (MACE)', 'timeFrame': '6 M', 'description': 'Death, non-fatal MI, clinically driven target vessel revascularization (TVR)'}], 'secondaryOutcomes': [{'measure': 'MACE', 'timeFrame': '12 M', 'description': 'Death, non-fatal MI, clinically driven TVR'}, {'measure': 'All MACE', 'timeFrame': '1, 6, and12 M', 'description': 'Death, non-fatal MI, any revascularization'}, {'measure': 'Clinically driven TVR', 'timeFrame': '1, 6 and 12 M'}, {'measure': 'Acute success', 'timeFrame': 'Post procedure', 'description': 'Clinical device success, clinical procedure success'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '24345357', 'type': 'RESULT', 'citation': 'Toelg R, Merkely B, Erglis A, Hoffman S, Bruno H, Kornowski R, Slagboom T, Naber C, Witzenbichler B, Graf K, Richardt G, Hehrlein C; DELUX investigators. Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry. EuroIntervention. 2014 Sep;10(5):591-9. doi: 10.4244/EIJV10I5A102.'}]}, 'descriptionModule': {'briefSummary': 'All comers registry - Evaluation of the safety and efficacy of the Pantera Lux Paclitaxel releasing balloon for coronary arteries in daily clinical practice.', 'detailedDescription': 'All patients are treated with the Pantera Lux Paclitaxel releasing balloon.\n\nClinical follow ups at 1, 6 and 12 months after coronary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All comers registry. Patients treated with the Pantera Lux Paclitaxel releasing balloon catheter are enrolled consecutively to represent a typical set of patients at each site.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Signed Patient Informed Consent / Data Release Form\n* Patient eligible for percutaneous coronary intervention (PCI)\n* Patient is older than 18 years of age\n\nExclusion Criteria\n\n* Patient has a known allergy against appropriate anticoagulation / antiplatelet therapy\n* Patients with known allergy against paclitaxel or BTHC\n* Patients with a target lesion that was previously treated by brachytherapy\n* Pregnant woman or lactating woman'}, 'identificationModule': {'nctId': 'NCT01081366', 'briefTitle': 'Drug Eluting Pantera Lux Catheter Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik AG'}, 'officialTitle': 'Evaluation of the Safety Profile of the Pantera Lux Paclitaxel Releasing Balloon for Coronary Arteries in Daily Clinical Practice', 'orgStudyIdInfo': {'id': 'C0905 DELUX'}}, 'contactsLocationsModule': {'locations': [{'zip': '23795', 'city': 'Bad Segeberg', 'country': 'Germany', 'facility': 'Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}], 'overallOfficials': [{'name': 'Raph Toelg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Am Kurpark 1, 23795 Bad Segeberg, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}