Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-28 @ 8:20 AM
Study NCT ID:
NCT02554292
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2015-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Surveillance of SeQuent Please Neo With Scoring Balloon
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': 481}, 'targetDuration': '9 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2015-09-17', 'studyFirstSubmitQcDate': '2015-09-17', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Vessel Failure', 'timeFrame': '9 months', 'description': 'Target Vessel Failure = TLR + Myocardial Infarction (MI) + cardiac death'}], 'secondaryOutcomes': [{'measure': 'procedural success rate', 'timeFrame': 'intraprocedural', 'description': 'lesion crossing success in in-stent restenotic lesions'}, {'measure': 'Target Lesion Revascularization rate = Re-PCI + CABG(TLR)', 'timeFrame': '9 months'}, {'measure': 'cardiac death', 'timeFrame': '9 months', 'description': 'death of cardiac or unknown causes'}, {'measure': 'Rate of coronary arterial bypass grafting (CABG)', 'timeFrame': '9 months'}, {'measure': 'rate of myocardial infarction', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease (CAD)']}, 'referencesModule': {'references': [{'pmid': '23040575', 'type': 'BACKGROUND', 'citation': 'Wohrle J, Zadura M, Mobius-Winkler S, Leschke M, Opitz C, Ahmed W, Barragan P, Simon JP, Cassel G, Scheller B. SeQuentPlease World Wide Registry: clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol. 2012 Oct 30;60(18):1733-8. doi: 10.1016/j.jacc.2012.07.040. Epub 2012 Oct 3.'}, {'pmid': '21624553', 'type': 'BACKGROUND', 'citation': 'Almalla M, Schroder JW, Pross V, Stegemann E, Marx N, Hoffmann R. Everolimus-eluting versus paclitaxel-eluting stents for treatment of bare metal stent restenosis. Am J Cardiol. 2011 Aug 15;108(4):518-22. doi: 10.1016/j.amjcard.2011.03.080. Epub 2011 May 31.'}, {'pmid': '26003022', 'type': 'RESULT', 'citation': 'Kufner S, Cassese S, Valeskini M, Neumann FJ, Schulz-Schupke S, Hoppmann P, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A, Byrne RA; ISAR-DESIRE 3 Investigators. Long-Term Efficacy and Safety of Paclitaxel-Eluting Balloon for the Treatment of Drug-Eluting Stent Restenosis: 3-Year Results of a Randomized Controlled Trial. JACC Cardiovasc Interv. 2015 Jun;8(7):877-84. doi: 10.1016/j.jcin.2015.01.031. Epub 2015 May 20.'}, {'pmid': '22386286', 'type': 'RESULT', 'citation': 'Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wohrle J. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol. 2012 Apr 10;59(15):1377-82. doi: 10.1016/j.jacc.2012.01.015. Epub 2012 Feb 29.'}, {'pmid': '23206837', 'type': 'RESULT', 'citation': 'Byrne RA, Neumann FJ, Mehilli J, Pinieck S, Wolff B, Tiroch K, Schulz S, Fusaro M, Ott I, Ibrahim T, Hausleiter J, Valina C, Pache J, Laugwitz KL, Massberg S, Kastrati A; ISAR-DESIRE 3 investigators. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial. Lancet. 2013 Feb 9;381(9865):461-7. doi: 10.1016/S0140-6736(12)61964-3. Epub 2012 Dec 1.'}, {'pmid': '24556098', 'type': 'RESULT', 'citation': 'Xu B, Gao R, Wang J, Yang Y, Chen S, Liu B, Chen F, Li Z, Han Y, Fu G, Zhao Y, Ge J; PEPCAD China ISR Trial Investigators. A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug-eluting stent in-stent restenosis: results from the PEPCAD China ISR trial. JACC Cardiovasc Interv. 2014 Feb;7(2):204-211. doi: 10.1016/j.jcin.2013.08.011.'}, {'pmid': '32274746', 'type': 'DERIVED', 'citation': 'Bonaventura K, Schwefer M, Yusof AKM, Waliszewski M, Krackhardt F, Steen P, Ocaranza R, Zuhdi AS, Bang LH, Graf K, Bock U, Chin K. Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study. Adv Ther. 2020 May;37(5):2210-2223. doi: 10.1007/s12325-020-01320-2. Epub 2020 Apr 9.'}]}, 'descriptionModule': {'briefSummary': "The main objective of the SeQuent® Please Neo post market surveillance is to assess the clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloon before the use of the paclitaxel-coated SeQuent® Please Neo in an 'all comer'/ 'real world' setting for the treatment of in-stent restenosis and de-novo lesions.", 'detailedDescription': 'The aim of this post market surveillance is to document the safety and efficacy of the drug-coated balloon Sequent® Please Neo in combination with the NSE Alpha scoring balloon in the treatment of both in-stent restenosis and de-novo lesions in native coronary arteries with reference diameters of 2.5 mm up to 4.0 mm with lesion lengths of 30 mm for procedural success and preservation of vessel patency'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery disease, specifically with in-stent restenosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with in-stent restenosis and de-novo lesions in coronary arteries\n\nExclusion Criteria:\n\n* Intolerance to paclitaxel and/or the balloon coating\n* Allergy to components of the balloon coating\n* Pregnancy and lactation\n* Complete occlusion of the treatment vessel\n* Severely calcified stenosis\n* Cardiogenic shock\n* Risk of an intraluminal thrombus\n* Haemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy'}, 'identificationModule': {'nctId': 'NCT02554292', 'acronym': 'PASSWORD', 'briefTitle': 'Post Market Surveillance of SeQuent Please Neo With Scoring Balloon', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Melsungen AG'}, 'officialTitle': 'Post MArket Surveillance of SeQuent Please Neo With ScORing Balloon Lesion Preparation in Real WorlD Patients', 'orgStudyIdInfo': {'id': 'AAG-O-A-1507'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation', 'type': 'DEVICE', 'otherNames': ['SeQuent® Please Neo Drug Coated Balloon, NSE Alpha Scoring Balloon'], 'description': 'Percutaneous Coronary Intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14467', 'city': 'Potsdam', 'country': 'Germany', 'facility': 'Klinikum Ernst von Bergmann', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}], 'overallOfficials': [{'name': 'Klaus Bonaventura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Ernst von Bergmann'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ernst von Bergmann Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}