Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-27 @ 4:06 PM
Study NCT ID:
NCT02784405
Status:
UNKNOWN
Last Update Posted:
2016-12-19
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-apposing Stentys Stents 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': 'ESTIMATED', 'count': 100}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-16', 'studyFirstSubmitDate': '2016-04-22', 'studyFirstSubmitQcDate': '2016-05-24', 'lastUpdatePostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiovascular Events (MACE)', 'timeFrame': '12 months', 'description': 'A composite end-point of death, myocardial infarction, stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': '12 months'}, {'measure': 'Myocardial Infarction', 'timeFrame': '12 months', 'description': 'Incident rate of myocardial infarction'}, {'measure': 'Stent thrombosis', 'timeFrame': '12 months', 'description': 'Incident rate of stent thrombosis'}, {'measure': 'Target lesion revascularization', 'timeFrame': '12 months', 'description': 'Incident rate of target lesion revascularization'}, {'measure': 'Unplanned hospitalization for unstable angina', 'timeFrame': '12 months', 'description': 'Incident rate of unplanned hospitalization for unstable angina'}, {'measure': 'Procedural and in-hospital complications', 'timeFrame': '30 days', 'description': 'Incident rate of periprocedural myocardial infarction, bleedings and access site complication, failure to cross stent struts with guidewire in the treatment of bifurcation, failure to delivery the stent, contrast-induced nephropathy'}, {'measure': 'Bleeding events', 'timeFrame': '12 months', 'description': 'Incident rate of bleedings classified according to the BARC criteria'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['percutaneous coronary intervention', 'stent implantation'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '25983027', 'type': 'BACKGROUND', 'citation': 'Lu H, IJsselmuiden AJ, Grundeken MJ, Nassif M, de Vries AG, Weevers A, Scholte M, Spaargaren R, Wykrzykowska JJ, Tijssen JG, de Winter RJ, Koch KT. First-in-man evaluation of the novel balloon delivery system STENTYS Xposition S for the self-apposing coronary artery stent: impact on longitudinal geographic miss during stenting. EuroIntervention. 2016 Mar;11(12):1341-5. doi: 10.4244/EIJY15M05_07.'}, {'pmid': '25983152', 'type': 'BACKGROUND', 'citation': 'Pyxaras SA, Schmitz T, Naber CK. The STENTYS Self-Apposing(R) stent. EuroIntervention. 2015;11 Suppl V:V147-8. doi: 10.4244/EIJV11SVA34. No abstract available.'}, {'pmid': '22514149', 'type': 'BACKGROUND', 'citation': 'Farooq V, Gomez-Lara J, Brugaletta S, Gogas BD, Garcia-Garcia HM, Onuma Y, van Geuns RJ, Bartorelli A, Whitbourn R, Abizaid A, Serruys PW. Proximal and distal maximal luminal diameters as a guide to appropriate deployment of the ABSORB everolimus-eluting bioresorbable vascular scaffold: a sub-study of the ABSORB Cohort B and the on-going ABSORB EXTEND Single Arm Study. Catheter Cardiovasc Interv. 2012 May 1;79(6):880-8. doi: 10.1002/ccd.23177. Epub 2011 Oct 5.'}, {'pmid': '11785994', 'type': 'BACKGROUND', 'citation': 'Uren NG, Schwarzacher SP, Metz JA, Lee DP, Honda Y, Yeung AC, Fitzgerald PJ, Yock PG; POST Registry Investigators. Predictors and outcomes of stent thrombosis: an intravascular ultrasound registry. Eur Heart J. 2002 Jan;23(2):124-32. doi: 10.1053/euhj.2001.2707.'}, {'pmid': '26340130', 'type': 'BACKGROUND', 'citation': 'Yew KL, Kang Z. First-in-man unprotected left main stenting with Stentys Xposition S self-apposing sirolimus eluting stent and optical coherence tomography guidance: The emerging panacea for left main intervention. Int J Cardiol. 2015 Dec 15;201:628-30. doi: 10.1016/j.ijcard.2015.08.035. Epub 2015 Aug 4. No abstract available.'}, {'pmid': '26188831', 'type': 'BACKGROUND', 'citation': 'Buccheri D, Orrego PS, Cortese B. Drug-eluting stent treatment of left main coronary artery disease: the case for a sirolimus-eluting, autoexpandable alternative. An optical coherence tomography analysis. Int J Cardiol. 2015 Nov 15;199:119-20. doi: 10.1016/j.ijcard.2015.07.006. Epub 2015 Jul 11. No abstract available.'}, {'pmid': '26865444', 'type': 'BACKGROUND', 'citation': 'van Geuns RJ, Yetgin T, La Manna A, Tamburino C, Souteyrand G, Motreff P, Koch KT, Vrolix M, IJsselmuiden A, Amoroso G, Berland J, Montalescot G, Teiger E, Christiansen EH, Spaargaren R, Wijns W. STENTYS Self-Apposing sirolimus-eluting stent in ST-segment elevation myocardial infarction: results from the randomised APPOSITION IV trial. EuroIntervention. 2016 Feb;11(11):e1267-74. doi: 10.4244/EIJV11I11A248.'}, {'pmid': '26666346', 'type': 'BACKGROUND', 'citation': 'Yew KL. Longitudinal stent foreshortening of Stentys Xposition S self-apposing stents and its impact on overlapping stenting strategy. Int J Cardiol. 2016 Feb 1;204:187-8. doi: 10.1016/j.ijcard.2015.11.176. Epub 2015 Nov 25. No abstract available.'}, {'pmid': '30298593', 'type': 'DERIVED', 'citation': "Montefusco A, D'Ascenzo F, Gili S, Smolka G, Chieffo A, Baumbach A, Escaned J, Sganzerla P, Tomassini F, Secco GG, Ugo F, Tamburino C, Nicolino A, Mancone M, Poli A, Yew KL, Cirillo P, Wanha W, Pastormerlo LE, di Summa R, Sardella G, Colombo A, Gaita F, Cortese B. Self-expandable sirolimus-eluting stents compared to second-generation drug-eluting stents for the treatment of the left main: A propensity score analysis from the SPARTA and the FAILS-2 registries. Catheter Cardiovasc Interv. 2019 Feb 1;93(2):208-215. doi: 10.1002/ccd.27809. Epub 2018 Oct 8."}]}, 'descriptionModule': {'briefSummary': 'Self-apposing, drug-eluting Stentys coronary stents represent a valuable tool for the treatment of coronary artery stenosis. Their ability to adapt to widely varying vessel calibers and to auto-expand after their release to self-appose to vessel walls is particularly useful in the presence of ectasic coronary arteries or significant vessel tapering. The investigators planned this study to assess the feasibility, the effectiveness and the safety of the implantation of self-apposing, drug-eluting Stentys stents for percutaneous coronary intervention.\n\nConsecutive patients undergoing percutaneous coronary intervention with implantation of a self-apposing Stentys stent were enrolled in this multi center registry. Inclusion criteria were age ≥ 18 years and ability to provide informed consent. No exclusion criteria were defined.\n\nPrimary end-point of the study is the occurrence of MACE (death, myocardial infarction, stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization). Secondary end-points include individual components of MACE, procedural complications (periprocedural MI, bleedings, access site complication, failure to cross stent struts with guidewire in the treatment of bifurcation, failure to delivery the stent, contrast-induced nephropathy), bleedings at follow up.', 'detailedDescription': 'Rationale: Choice of the appropriate size of stents in the treatment of coronary artery stenosis can often be challenging. Marked tapering of vessels\' diameter in their proximal-distal development may lead to sub-optimal results. Distal under-expansion of the drug-eluting stent (DES) or vessel perforation may occur if a larger DES, best suited for the proximal diameter, is chosen. Proximal DES under-sizing with struts malapposition may happen if a smaller DES, fitting the distal diameter, is implanted. Moreover, ectasic vessels present irregular and varying diameter, which may lead as well to segmental malapposition or under-expansion of DES. Self-apposing stents can overcome these limitations thanks to their ability to self-expand also after their release in the vessel and to adapt to a wide range of vessel diameters. Multiple generation of self-apposing, drug-eluting stents have been developed, with progressive amendments pertaining the stent-deployment technique (from deployment by covering-sheath retraction to balloon-delivery) and the drug released (from paclitaxel to sirolimus). The last generation of the self-apposing stents is represented by the sirolimus-eluting, balloon-delivered Xposition S stents. Studies assessing performance of this stent are however limited in sample size and length of follow up, and are mainly controlled trials. Few data are available regarding the clinical outcomes of the self-apposing Stentys stents in a "real-life" setting.\n\nAim of this study is to assess the feasibility, the effectiveness and the safety of the implantation of self-apposing, drug-eluting Stentys stents for percutaneous coronary intervention.\n\nStudy population: Patients undergoing percutaneous coronary intervention with implantation of a self-apposing Stentys stent.\n\nPrimary analysis: Longitudinal cohort follow up\n\nStudy end-points:\n\nPrimary efficacy end-point:\n\n* Major adverse cardiovascular events (MACE) (a composite end point including death, myocardial infarction (MI, excluding periprocedural MI), stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization (TLR))\n\nSecondary efficacy end-points:\n\n* Individual components of MACE (death, MI, stent thrombosis, unplanned hospitalization, TLR)\n\nSecondary safety end-points:\n\n* Procedural complications:\n\n * Periprocedural MI\n * Bleedings\n * Access site complication\n * Failure to cross stent struts with guidewire in the treatment of bifurcation\n * Failure to delivery the stent\n * Contrast-induced nephropathy\n* Bleedings at follow up'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients undergoing percutaneous treatment of coronary artery disease with implantation of a self-apposing, drug-eluting, Stentys stent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years old\n* ability to provide informed consent\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02784405', 'acronym': 'SPARTA', 'briefTitle': 'Self-apposing Stentys Stents Registry', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': 'Safety and Effectiveness of the Self-aPposing, bAlloon-delivered, dRug-eluting Stent for the Treatment of the Coronary Artery Disease: A multiCenter Registry', 'orgStudyIdInfo': {'id': 'sparta2016'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ascoli Piceno', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luciano Moretti, MD', 'role': 'CONTACT'}, {'name': 'Simona Silenzi, MD', 'role': 'CONTACT'}, {'name': 'Pierfrancesco Grossi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Division of Cardiology, Mazzoni Hospital', 'geoPoint': {'lat': 42.85351, 'lon': 13.57395}}, {'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessio La Manna, MD', 'role': 'CONTACT'}], 'facility': 'Ferrarotto Hospital, University of Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Cirié', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pietro Gaetano, MD', 'role': 'CONTACT'}], 'facility': 'Division of Cardiology, ASL TO4', 'geoPoint': {'lat': 45.23486, 'lon': 7.60125}}, {'city': 'Conegliano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Pavei, MD', 'role': 'CONTACT'}], 'facility': 'Division of Cardiology, Santa Maria dei Battuti Hospital', 'geoPoint': {'lat': 45.88805, 'lon': 12.30201}}, {'city': 'Legnano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Arnaldo Poli, MD', 'role': 'CONTACT'}], 'facility': 'Division of Cardiology, Ospedale Civile di Legnano - ASST Ovest Mi', 'geoPoint': {'lat': 45.59788, 'lon': 8.91506}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Bernardo Cortese, MD', 'role': 'CONTACT'}, {'name': 'Bernardo Cortese, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Interventional Cardiology, Azienda Ospedaliera Fatebenefratelli', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Esposito, MD, Prof', 'role': 'CONTACT'}, {'name': 'Plinio Cirillo, MD, Prof', 'role': 'CONTACT'}], 'facility': 'Division of Cardiology, Federico II University', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Pietra Ligure', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Maria Nicolino, MD', 'role': 'CONTACT'}], 'facility': 'Division of Cardiology, Santa Corona Hospital', 'geoPoint': {'lat': 44.1492, 'lon': 8.28206}}, {'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luigi Emilio Pastormerlo, MD', 'role': 'CONTACT'}, {'name': 'Cataldo Palmieri, MD', 'role': 'CONTACT'}], 'facility': 'Division of Cardiology, Fondazione Toscana G Monasterio', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gennaro Sardella, MD', 'role': 'CONTACT'}, {'name': 'Massimo Mancone, MD', 'role': 'CONTACT'}, {'name': 'Gennaro Sardella, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Massimo Mancone, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Simone Calcagno, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Division of Cardiology, Policlinico Umberto I, La Sapienza University', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Treviglio', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Sganzerla, MD', 'role': 'CONTACT'}], 'facility': 'Division of Cardiology, ASST Bergamo Ovest', 'geoPoint': {'lat': 45.52081, 'lon': 9.59102}}, {'zip': '10126', 'city': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sebastiano Gili, MD', 'role': 'CONTACT', 'email': 'sebastiano.gili@gmail.com'}, {'name': 'Antonio Montefusco, MD', 'role': 'CONTACT', 'email': 'anto.montefusco@gmail.com'}, {'name': 'Claudio Moretti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antonio Montefusco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sebastiano Gili, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'AO Città della Salute e della Scienza', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'city': 'Kuala Selangor', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Kuan Leong Yew, MD, Prof', 'role': 'CONTACT'}], 'facility': 'Cardiology Department, Manipal Klang Hospital', 'geoPoint': {'lat': 3.35, 'lon': 101.25}}, {'city': 'Katowice', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Grzegorz Smolka, MD, Prof', 'role': 'CONTACT'}], 'facility': 'Division of Cardiology, Medical University of Silesia', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}], 'centralContacts': [{'name': 'Sebastiano Gili, MD', 'role': 'CONTACT', 'email': 'sebastiano.gili@gmail.com', 'phone': '+393338354923'}, {'name': 'Antonio Montefusco, MD', 'role': 'CONTACT', 'email': 'anto.montefusco@gmail.com'}], 'overallOfficials': [{'name': 'Claudio Moretti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology, Department of Medical Sciences, AO Città della Salute e della Scienza, University of Turin, Turin, Italy'}, {'name': 'Antonio Montefusco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology, Department of Medical Sciences, AO Città della Salute e della Scienza, University of Turin, Turin, Italy'}, {'name': 'Bernardo Cortese, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Interventional Cardiology, A.O. Fatebenefratelli Milano, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Claudio Moretti', 'investigatorAffiliation': 'A.O.U. Città della Salute e della Scienza'}}}}