Clinical trial NCT02066623: Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold
Official title: German-Austrian Register to Evaluate the Short and Long-term Safety and Therapy Outcomes of the ABSORB Everolimus-eluting Bioresorbable Vascular Scaffold System in Patients With Coronary Artery Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Stenosis
Keywords: coronary artery stenosis, vascular scaffold, ABSORB
Lead sponsor: IHF GmbH - Institut für Herzinfarktforschung
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2014-02-19
Enrollment: 3330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients in Germany and Austria having been implanted with ABSORB scaffold system

Brief summary: The German-Austrian ABSORB Register shall provide an analysis of acute and long-term safety as well as therapy outcomes of the ABSORB (trade mark) bioresorbable vascular scaffold system in patients suffering from coronary artery disease.

Detailed description: The register collects prospective data regarding the quality of care of this therapy concept including specifically the following objectives:

* 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

Eligibility criteria: Inclusion Criteria:

* ABSORB implant scheduled
* Age 18+
* Patients giving consent to keep scheduled follow-ups
* Signed informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of serious adverse cardiac events
timeFrame: 5 years after index procedure
Secondary outcomes:
measure: Success of ABSORB implantation
timeFrame: during implantation of ABSORB scaffold
Other outcomes:
measure: Effectiveness of ABSORB implantation
timeFrame: 5 years follow-up period
measure: Change in quality of life
timeFrame: 5 years follow-up period
measure: Health-economical effects of ABSORB scaffold implantation
timeFrame: 5 years follow-up period
Locations:
city: Vienna
country: Austria
facility: Medizinische Universität Wien
state: Wien
city: Graz
country: Austria
facility: Landeskrankenhaus-Univ.Klinikum Graz
city: Graz
country: Austria
facility: LKH Graz-West
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Linz
country: Austria
facility: A.ö. Krankenhaus der Stadt Linz
city: Villach
country: Austria
facility: LKH Villach
city: Arnstadt
country: Germany
facility: Ilm-Kreis-Kliniken, Arnstadt-Ilmenau
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Bad Friedrichshall
country: Germany
facility: SLK-Kliniken, Klinikum am Plattenwald
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Bad Langensalza
country: Germany
facility: Hufeland Klinikum
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken
city: Berlin
country: Germany
facility: Caritas-Klinik Pankow
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin - Campus Virchow-Klinikum
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin-Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandau
city: Berlin
country: Germany
facility: Vivantes-Klinikum Am Urban
city: Berlin
country: Germany
facility: Vivantesklinik im Friedrichshain
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau
city: Bitterfeld-Wolfen
country: Germany
facility: Gesundheitszentrum Bitterfeld-Wolfen
city: Bochum
country: Germany
facility: St. Josef- und Elisabeth- Hospital
city: Bremen
country: Germany
facility: Klinikum Links der Weser
city: Buchholz
country: Germany
facility: Krankenhaus Buchholz
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Cottbus
country: Germany
facility: Sana-Herzzentrum Cottbus
city: Darmstadt
country: Germany
facility: Kardiovaskuläres Zentrum Darmstadt
city: Dresden
country: Germany
facility: Praxisklinik Herz und Gefässe Dresden
city: Eberswalde
country: Germany
facility: Werner-Forßmann-Krankenhaus
city: Eichstätt
country: Germany
facility: Kliniken Im Naturpark Altmühltal, Klinik Eichstätt
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Alfried Krupp v. Bohlen Krankenhaus
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Fulda
country: Germany
facility: Klinikum Fulda
city: Gelnhausen
country: Germany
facility: Main-Kinzig-Kliniken
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald
city: Göttingen
country: Germany
facility: Universitätsklinikum Göttingen
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Eppendorf
city: Hannover
country: Germany
facility: Med. Hochschule Hannover
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn
city: Hennigsdorf
country: Germany
facility: Oberhavel Kliniken-Klinik Hennigsdorf
city: Herford
country: Germany
facility: Krankenhaus Herford
city: Immenstadt
country: Germany
facility: Herz- und Gefäßzentrum Oberallgäu-Kempten
city: Itzehoe
country: Germany
facility: Klinikum Itzehoe
city: Kempten
country: Germany
facility: Herz- und Gefäßzentrum Oberallgäu/Kempten
city: Koblenz
country: Germany
facility: Stiftungsklinikum Mittelrhein
city: Köln
country: Germany
facility: Herzzentrum Universitätsklinikum Köln
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Ludwigshafen am Rhein
country: Germany
facility: Klinikum Ludwigshafen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig Holstein
city: Lüdenscheid
country: Germany
facility: Klinikum Lüdenscheid
city: Lünen
country: Germany
facility: St. Marien-Hospital
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Mainz
country: Germany
facility: Universitätsklinikum Mainz
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Marburg
country: Germany
facility: Universitätsklinikum Marburg
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
city: Munich
country: Germany
facility: Isar Herz Zentrum München
city: Munich
country: Germany
facility: Klinikum der Universität München , Campus Großhadern
city: Munich
country: Germany
facility: Klinikum München-Bogenhausen
city: Munich
country: Germany
facility: Städtisches Klinikum München - Neuperlach
city: Mönchengladbach
country: Germany
facility: Krankenhaus St. Franziskus Mönchengladbach
city: Mülheim
country: Germany
facility: Evangelisches Krankenhaus Mülheim
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
city: Rüsselsheim
country: Germany
facility: GPR Klinikum Rüsselsheim
city: Siegen
country: Germany
facility: St. Marien-Krankenhaus
city: Stade
country: Germany
facility: Elbe Klinikum Stade
city: Suhl
country: Germany
facility: SRH Zentralklinikum Suhl
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Vechta
country: Germany
facility: St. Marienhospital
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum
city: Winnenden
country: Germany
facility: Rems-Murr-Klinik Winnenden
city: Zwickau
country: Germany
facility: Heinrich-Braun-Krankenhaus
Study officials:
affiliation: University Clinic Giessen and Kerckhoff-Clinic Bad Nauheim
name: Christian Hamm, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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