Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold

Coronary Artery Stenosis Clinical Trial

— GABI-R  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066623
• Other study ID #: GABI-R
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Stenosis
• Coronary Stenosis

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