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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02066623
Other study ID # GABI-R
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 8, 2013
Est. completion date July 6, 2021

Study information

Verified date July 2021
Source IHF GmbH - Institut für Herzinfarktforschung
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 3330
Est. completion date July 6, 2021
Est. primary completion date January 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - ABSORB implant scheduled - Age 18+ - Patients giving consent to keep scheduled follow-ups - Signed informed consent Exclusion Criteria: - None

Study Design


Intervention

Device:
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

Locations

Country Name City State
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 Medizinische Universität Wien Vienna Wien
Austria LKH Villach Villach
Germany 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 Bad Segeberg
Germany Segeberger Kliniken GmbH 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 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
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 Hannover
Germany SLK-Kliniken Heilbronn Heilbronn
Germany Oberhavel Kliniken-Klinik Hennigsdorf Hennigsdorf
Germany Krankenhaus Herford Herford
Germany Herz- und Gefäßzentrum Oberallgäu-Kempten Immenstadt
Germany Klinikum Itzehoe Itzehoe
Germany Herz- und Gefäßzentrum Oberallgäu/Kempten Kempten
Germany Stiftungsklinikum Mittelrhein Koblenz
Germany Herzzentrum Universitätsklinikum Köln Köln
Germany Universitätsklinikum Leipzig Leipzig
Germany Universitätsklinikum Schleswig Holstein Lübeck
Germany Klinikum Lüdenscheid Lüdenscheid
Germany Klinikum Ludwigshafen Ludwigshafen am Rhein
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 Evangelisches Krankenhaus Mülheim Mülheim
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 Universitätsmedizin Rostock Rostock
Germany GPR Klinikum Rüsselsheim Rüsselsheim
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

Sponsors (2)

Lead Sponsor Collaborator
IHF GmbH - Institut für Herzinfarktforschung Abbott Medical Devices

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (7)

Gori T, Achenbach S, Riemer T, Mehilli J, Nef HM, Naber C, Richardt G, Wöhrle J, Zahn R, Neumann T, Kastner J, Schmermund A, Hamm C, Münzel T. Hybrid Coronary Percutaneous Treatment with Metallic Stents and Everolimus-Eluting Bioresorbable Vascular Scaffo — View Citation

Hemetsberger R, Abdelghani M, Mankerious N, Allali A, Toelg R, Gori T, Achenbach S, Riemer T, Mehilli J, Nef HM, Naber C, Wöhrle J, Zahn R, Kastner J, Schmermund A, Hamm C, Münzel T, Richardt G; GABI-R Study Group. Impact of coronary calcification on outc — View Citation

Huseynov A, Baumann S, Nef H, Riemer T, Schneider S, Pfannenbecker T, Achenbach S, Mehilli J, Münzel T, Gori T, Wöhrle J, Zahn R, Kastner J, Schmermund A, Richardt G, Hamm CW, Akin I. Comparison between treatment of "established" versus complex "off-label — View Citation

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 vascula — View Citation

Nef H, Wiebe J, Achenbach S, Münzel T, Naber C, Richardt G, Mehilli J, Wöhrle 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. — View Citation

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 — View Citation

Wöhrle J, Nef HM, Naber C, Achenbach S, Riemer T, Mehilli J, Münzel 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 thrombosi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Effectiveness of ABSORB implantation Effectiveness of ABSORB implantation will be assessed based on the following parameters:
Target vessel failure (TVF): This includes cardiac death, target vessel myocardial infarction (Q-wave or non-Q-wave MI) or clinically motivated target vessel revascularization (TVR), percutaneous or surgical.
Target lesion failure (TLF): This includes cardiac death, target vessel myocardial infarction (Q-wave or non-Q-wave MI) or clinically motivated target lesion revascularization (TLR), percutaneous or surgical.
5 years follow-up period
Other Change in quality of life Changes in quality of life will be assessed by measuring
Angina pectoris scores (incl. CCS score, Canadian Cardiovascular Society score) and heart failure scores (NYHA, New York Heart Association score)
Standardized questionnaire for quality of life (EQ-5D)
Standardized questionnaire for health-related quality of life of patients with coronary artery disease (Seattle Angina Questionnaire, SAQ)
5 years follow-up period
Other Health-economical effects of ABSORB scaffold implantation Health-economical effects will be assessed by measuring
Direct costs: medication, visits to general practitioners and specialists, hospitalizations, inpatient and outpatient rehab, patient care services
Indirect costs: disability, reduced earning capacity
5 years follow-up period
Primary 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 Success of ABSORB implantation The following parameters will be evaluated to assess procedural outcome:
Technical success: If the residual stenosis is less than 30% in the ABSORB covered lesion segment at the end of the procedure based on visual estimation
Therapy success: Technical success and no periprocedural complications
Clinical success: Therapy success and no serious adverse cardiac (and cerebrovascular) events (MACE, MACCE)
TIMI (thrombolysis in myocardial infarction) flow pre and post implant
Sudden occlusion of side branch in the case of bifurcation stenosis
Optional: Quantitative coronary angiography (QCA) with index treatment: final in-scaffold and in-segment percentage diameter stenosis (%DS), reference vessel diameter
during implantation of ABSORB scaffold
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