Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold
GABI-R
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
1 other identifier
observational
3,330
2 countries
81
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Longer than P75 for all trials
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2013
CompletedFirst Submitted
Initial submission to the registry
January 20, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2021
CompletedApril 1, 2022
July 1, 2021
2.2 years
January 20, 2014
March 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of serious adverse cardiac events
The following events will be evaluated: * Death * Myocardial infarction * Clinically motivated target vessel revascularization * Clinically motivated target lesion revascularization * Composite target parameter of the aforementioned events (MACE, major adverse cardiac event) as the primary target parameter * Stroke * Composite target parameter of the aforementioned events including stroke as the primary target parameter (MACCE, major adverse cardiac and cerebrovascular event) * Stent thrombosis
5 years after index procedure
Secondary Outcomes (1)
Success of ABSORB implantation
during implantation of ABSORB scaffold
Other Outcomes (3)
Effectiveness of ABSORB implantation
5 years follow-up period
Change in quality of life
5 years follow-up period
Health-economical effects of ABSORB scaffold implantation
5 years follow-up period
Study Arms (1)
Implantation of ABSORB Scaffold
Patients suffering from coronary artery stenosis with an indication for implantation of ABSORB scaffold
Interventions
Implantation of a drug-eluting vascular scaffold, which is completely resorbable to improve the blood flow in coronary arteries in the presence of stenosis
Eligibility Criteria
All patients in Germany and Austria having been implanted with ABSORB scaffold system
You may qualify if:
- ABSORB implant scheduled
- Age 18+
- Patients giving consent to keep scheduled follow-ups
- Signed informed consent
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Medizinische Universität Wien
Vienna, Vienna, A-1090, 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, 23795, 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, 35392, 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, 87439, Germany
Stiftungsklinikum Mittelrhein
Koblenz, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Klinikum Ludwigshafen
Ludwigshafen am Rhein, 67063, 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
Related Publications (11)
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.
PMID: 26431767BACKGROUNDMehilli 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.
PMID: 28649953RESULTNef 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.
PMID: 28829745RESULTWohrle 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.
PMID: 29649071RESULTHuseynov 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.
PMID: 31256259RESULTHemetsberger 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.
PMID: 32271247RESULTGori 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.
PMID: 31151213RESULTPahmeier 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.
PMID: 35987601DERIVEDWein 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.
PMID: 34844868DERIVEDBoeder 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.
PMID: 34143547DERIVEDZaczkiewicz 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.
PMID: 32258361DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Hamm, Prof. Dr.
University Clinic Giessen and Kerckhoff-Clinic Bad Nauheim
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2014
First Posted
February 19, 2014
Study Start
November 8, 2013
Primary Completion
January 31, 2016
Study Completion
July 6, 2021
Last Updated
April 1, 2022
Record last verified: 2021-07