Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold
NCT ID: NCT02066623
Last Updated: 2022-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3330 participants
OBSERVATIONAL
2013-11-08
2021-07-06
Brief Summary
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Detailed Description
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* Documentation of all consecutive patients having been treated with the ABSORB biore-sorbable vascular scaffold system under clinical real-world conditions
* Documentation of indications, procedural results, and short and long-term outcomes
* Documentation of the technical performance of ABSORB implant procedures
* Collection of safety data, in particular documentation of hospital mortality, major non-fatal complications (especially myocardial infarction, Re-PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting), stroke, thrombosis)
* Documentation of long-term patient safety marked by mortality and major non-fatal complications (especially myocardial infarction, Re-PCI or CABG, stroke, thrombosis) at 30 days, 6 months, 2 years and 5 years
* Gathering of health economics data (capture of direct costs, especially with view to change of medication and outpatient/inpatient hospital services, and indirect costs) pre and post ABSORB implant
* Gathering data on the quality of life pre and post ABSORB implant to document individual QoL dimensions as well as QALY (quality adjusted life year) data
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Implantation of ABSORB Scaffold
Patients suffering from coronary artery stenosis with an indication for implantation of ABSORB scaffold
ABSORB Scaffold
Implantation of a drug-eluting vascular scaffold, which is completely resorbable to improve the blood flow in coronary arteries in the presence of stenosis
Interventions
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ABSORB Scaffold
Implantation of a drug-eluting vascular scaffold, which is completely resorbable to improve the blood flow in coronary arteries in the presence of stenosis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18+
* Patients giving consent to keep scheduled follow-ups
* Signed informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
IHF GmbH - Institut für Herzinfarktforschung
OTHER
Responsible Party
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Principal Investigators
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Christian Hamm, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Clinic Giessen and Kerckhoff-Clinic Bad Nauheim
Locations
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Medizinische Universität Wien
Vienna, Vienna, Austria
Landeskrankenhaus-Univ.Klinikum Graz
Graz, , Austria
LKH Graz-West
Graz, , Austria
Medizinische Universität Innsbruck
Innsbruck, , Austria
A.ö. Krankenhaus der Stadt Linz
Linz, , Austria
LKH Villach
Villach, , Austria
Ilm-Kreis-Kliniken, Arnstadt-Ilmenau
Arnstadt, , Germany
Zentralklinik Bad Berka
Bad Berka, , Germany
SLK-Kliniken, Klinikum am Plattenwald
Bad Friedrichshall, , Germany
Herzzentrum Bad Krozingen
Bad Krozingen, , Germany
Hufeland Klinikum
Bad Langensalza, , Germany
Kerckhoff-Klinik
Bad Nauheim, , Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, , Germany
Segeberger Kliniken GmbH
Bad Segeberg, , Germany
Segeberger Kliniken
Bad Segeberg, , Germany
Caritas-Klinik Pankow
Berlin, , Germany
Charité - Universitätsmedizin Berlin - Campus Virchow-Klinikum
Berlin, , Germany
Charité - Universitätsmedizin Berlin-Campus Benjamin Franklin
Berlin, , Germany
Vivantes Klinikum Neukölln
Berlin, , Germany
Vivantes Klinikum Spandau
Berlin, , Germany
Vivantes-Klinikum Am Urban
Berlin, , Germany
Vivantesklinik im Friedrichshain
Berlin, , Germany
Immanuel Klinikum Bernau
Bernau, , Germany
Gesundheitszentrum Bitterfeld-Wolfen
Bitterfeld-Wolfen, , Germany
St. Josef- und Elisabeth- Hospital
Bochum, , Germany
Klinikum Links der Weser
Bremen, , Germany
Krankenhaus Buchholz
Buchholz, , Germany
Klinikum Coburg
Coburg, , Germany
Herzzentrum Universitätsklinikum Köln
Cologne, , Germany
Sana-Herzzentrum Cottbus
Cottbus, , Germany
Kardiovaskuläres Zentrum Darmstadt
Darmstadt, , Germany
Praxisklinik Herz und Gefässe Dresden
Dresden, , Germany
Werner-Forßmann-Krankenhaus
Eberswalde, , Germany
Kliniken Im Naturpark Altmühltal, Klinik Eichstätt
Eichstätt, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Alfried Krupp v. Bohlen Krankenhaus
Essen, , Germany
Elisabeth Krankenhaus Essen
Essen, , Germany
Universitätsklinikum Essen
Essen, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Klinikum Fulda
Fulda, , Germany
Main-Kinzig-Kliniken
Gelnhausen, , Germany
Universitätsklinikum Gießen
Giessen, , Germany
Universitätsklinikum Göttingen
Göttingen, , Germany
Universitätsklinikum Greifswald
Greifswald, , Germany
Asklepios Klinik Harburg
Hamburg, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Universitäres Herzzentrum Eppendorf
Hamburg, , Germany
Med. Hochschule Hannover
Hanover, , Germany
SLK-Kliniken Heilbronn
Heilbronn, , Germany
Oberhavel Kliniken-Klinik Hennigsdorf
Hennigsdorf, , Germany
Krankenhaus Herford
Herford, , Germany
Herz- und Gefäßzentrum Oberallgäu-Kempten
Immenstadt im Allgäu, , Germany
Klinikum Itzehoe
Itzehoe, , Germany
Herz- und Gefäßzentrum Oberallgäu/Kempten
Kempten, , Germany
Stiftungsklinikum Mittelrhein
Koblenz, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Klinikum Ludwigshafen
Ludwigshafen am Rhein, , Germany
Universitätsklinikum Schleswig Holstein
Lübeck, , Germany
Klinikum Lüdenscheid
Lüdenscheid, , Germany
St. Marien-Hospital
Lünen, , Germany
Universitätsklinikum Magdeburg
Magdeburg, , Germany
Universitätsklinikum Mainz
Mainz, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
Universitätsklinikum Marburg
Marburg, , Germany
Krankenhaus St. Franziskus Mönchengladbach
Mönchengladbach, , Germany
Deutsches Herzzentrum München
Munich, , Germany
Isar Herz Zentrum München
Munich, , Germany
Klinikum der Universität München , Campus Großhadern
Munich, , Germany
Klinikum München-Bogenhausen
Munich, , Germany
Städtisches Klinikum München - Neuperlach
Munich, , Germany
Evangelisches Krankenhaus Mülheim
Mülheim, , Germany
Universitätsmedizin Rostock
Rostock, , Germany
GPR Klinikum Rüsselsheim
Rüsselsheim am Main, , Germany
St. Marien-Krankenhaus
Siegen, , Germany
Elbe Klinikum Stade
Stade, , Germany
SRH Zentralklinikum Suhl
Suhl, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
St. Marienhospital
Vechta, , Germany
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, , Germany
Rems-Murr-Klinik Winnenden
Winnenden, , Germany
Heinrich-Braun-Krankenhaus
Zwickau, , Germany
Countries
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References
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Nef H, Wiebe J, Achenbach S, Munzel T, Naber C, Richardt G, Mehilli J, Wohrle J, Neumann T, Biermann J, Zahn R, Kastner J, Schmermund A, Pfannebecker T, Schneider S, Limbourg T, Hamm CW. Evaluation of the short- and long-term safety and therapy outcomes of the everolimus-eluting bioresorbable vascular scaffold system in patients with coronary artery stenosis: Rationale and design of the German-Austrian ABSORB RegIstRy (GABI-R). Cardiovasc Revasc Med. 2016 Jan-Feb;17(1):34-7. doi: 10.1016/j.carrev.2015.09.002. Epub 2015 Sep 10.
Mehilli J, Achenbach S, Woehrle J, Baquet M, Riemer T, Muenzel T, Nef H, Naber C, Richardt G, Zahn R, Gori T, Neumann T, Kastner J, Schmermund A, Hamm C. Clinical restenosis and its predictors after implantation of everolimus-eluting bioresorbable vascular scaffolds: results from GABI-R. EuroIntervention. 2017 Dec 20;13(11):1319-1326. doi: 10.4244/EIJ-D-17-00291.
Nef HM, Wiebe J, Kastner J, Mehilli J, Muenzel T, Naber C, Neumann T, Richardt G, Schmermund A, Woehrle J, Zahn R, Riemer T, Achenbach S, Hamm CW. Everolimus-eluting bioresorbable scaffolds in patients with coronary artery disease: results from the German-Austrian ABSORB RegIstRy (GABI-R). EuroIntervention. 2017 Dec 20;13(11):1311-1318. doi: 10.4244/EIJ-D-17-00330.
Wohrle J, Nef HM, Naber C, Achenbach S, Riemer T, Mehilli J, Munzel T, Schneider S, Markovic S, Seeger J, Rottbauer W, Pfannebecker T, Richardt G, Zahn R, Gori T, Kastner J, Schmermund A, Hamm CW; GABI-R Study Group. Predictors of early scaffold thrombosis: results from the multicenter prospective German-Austrian ABSORB RegIstRy. Coron Artery Dis. 2018 Aug;29(5):389-396. doi: 10.1097/MCA.0000000000000618.
Huseynov A, Baumann S, Nef H, Riemer T, Schneider S, Pfannenbecker T, Achenbach S, Mehilli J, Munzel T, Gori T, Wohrle J, Zahn R, Kastner J, Schmermund A, Richardt G, Hamm CW, Akin I. Comparison between treatment of "established" versus complex "off-label" coronary lesions with Absorb(R) bioresorbable scaffold implantation: results from the GABI-R(R) registry. Clin Res Cardiol. 2020 Mar;109(3):374-384. doi: 10.1007/s00392-019-01517-8. Epub 2019 Jun 29.
Hemetsberger R, Abdelghani M, Mankerious N, Allali A, Toelg R, Gori T, Achenbach S, Riemer T, Mehilli J, Nef HM, Naber C, Wohrle J, Zahn R, Kastner J, Schmermund A, Hamm C, Munzel T, Richardt G; GABI-R Study Group. Impact of coronary calcification on outcomes after ABSORB scaffold implantation: insights from the GABI-R registry. Coron Artery Dis. 2020 Nov;31(7):578-585. doi: 10.1097/MCA.0000000000000870.
Gori T, Achenbach S, Riemer T, Mehilli J, Nef HM, Naber C, Richardt G, Wohrle J, Zahn R, Neumann T, Kastner J, Schmermund A, Hamm C, Munzel T. Hybrid Coronary Percutaneous Treatment with Metallic Stents and Everolimus-Eluting Bioresorbable Vascular Scaffolds: 2-years Results from the GABI-R Registry. J Clin Med. 2019 May 30;8(6):767. doi: 10.3390/jcm8060767.
Pahmeier K, Neusser S, Hamm C, Kastner J, Wohrle J, Zahn R, Achenbach S, Mehilli J, Gori T, Naber C, Nef H, Neumann T, Richardt G, Schmermund A, Claas C, Riemer T, Biermann-Stallwitz J; GABI-R Study Group. Quality of life of patients with coronary heart disease treated with the bioresorbable vascular scaffold (ABSORB): 2-year results from the GABI-R-registry. BMC Cardiovasc Disord. 2022 Aug 20;22(1):379. doi: 10.1186/s12872-022-02815-2.
Wein B, Zaczkiewicz M, Graf M, Zimmermann O, Gori T, Nef HM, Kastner J, Mehilli J, Richardt G, Wohrle J, Achenbach S, Riemer T, Hamm C, Torzewski J. No Difference in 30-Day Outcome and Quality of Life in Transradial Versus Transfemoral Access - Results From the German Austrian ABSORB Registry (GABI-R). Cardiovasc Revasc Med. 2022 Jul;40:144-149. doi: 10.1016/j.carrev.2021.11.022. Epub 2021 Nov 24.
Boeder NF, Kastner J, Mehilli J, Munzel T, Naber C, Neumann T, Richardt G, Schmermund A, Wohrle J, Zahn R, Riemer T, Achenbach S, Hamm CW, Nef HM; GABI-R Study Group. Predictors of scaffold failure and impact of optimized scaffold implantation technique on outcome: Results from the German-Austrian ABSORB RegIstRy. Catheter Cardiovasc Interv. 2021 Oct;98(4):E555-E563. doi: 10.1002/ccd.29829. Epub 2021 Jun 18.
Zaczkiewicz M, Wein B, Graf M, Zimmermann O, Kastner J, Wohrle J, Thomas R, Hamm C, Torzewski J; GABI-R Study Group. Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of </=18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R). Int J Cardiol Heart Vasc. 2020 Mar 20;27:100501. doi: 10.1016/j.ijcha.2020.100501. eCollection 2020 Apr.
Other Identifiers
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GABI-R
Identifier Type: -
Identifier Source: org_study_id
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