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Coronary Artery StenosisGABI-RNCT02066623

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

An observational study of Coronary Artery Stenosis, run by IHF GmbH - Institut für Herzinfarktforschung at 81 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Stenosis
What is being tested?
ABSORB Scaffold
Type of treatment
Medical device
How many people
3,330 participants
Where
81 sitesin 2 countries
Study dates
8 Nov 2013to 6 Jul 2021
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients in Germany and Austria having been implanted with ABSORB scaffold system

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

81 sites in 2 countries.

81 sites in 2 countries

Germany75 sites

  • Ilm-Kreis-Kliniken, Arnstadt-Ilmenau

    Arnstadt

  • Zentralklinik Bad Berka

    Bad Berka

  • SLK-Kliniken, Klinikum am Plattenwald

    Bad Friedrichshall

  • Herzzentrum Bad Krozingen

    Bad Krozingen

  • Hufeland Klinikum

    Bad Langensalza

  • Kerckhoff-Klinik

    Bad Nauheim

  • Herz- und Diabeteszentrum Nordrhein-Westfalen

    Bad Oeynhausen

  • Segeberger Kliniken GmbH

    Bad Segeberg, 23795

  • Segeberger Kliniken

    Bad Segeberg

  • Caritas-Klinik Pankow

    Berlin

  • Charité - Universitätsmedizin Berlin - Campus Virchow-Klinikum

    Berlin

  • Charité - Universitätsmedizin Berlin-Campus Benjamin Franklin

    Berlin

  • Vivantes Klinikum Neukölln

    Berlin

  • Vivantes Klinikum Spandau

    Berlin

  • Vivantes-Klinikum Am Urban

    Berlin

  • Vivantesklinik im Friedrichshain

    Berlin

  • Immanuel Klinikum Bernau

    Bernau

  • Gesundheitszentrum Bitterfeld-Wolfen

    Bitterfeld-Wolfen

  • St. Josef- und Elisabeth- Hospital

    Bochum

  • Klinikum Links der Weser

    Bremen

  • Krankenhaus Buchholz

    Buchholz

  • Klinikum Coburg

    Coburg

  • Herzzentrum Universitätsklinikum Köln

    Cologne

  • Sana-Herzzentrum Cottbus

    Cottbus

  • Kardiovaskuläres Zentrum Darmstadt

    Darmstadt

  • Praxisklinik Herz und Gefässe Dresden

    Dresden

  • Werner-Forßmann-Krankenhaus

    Eberswalde

  • Kliniken Im Naturpark Altmühltal, Klinik Eichstätt

    Eichstätt

  • Universitätsklinikum Erlangen

    Erlangen

  • Alfried Krupp v. Bohlen Krankenhaus

    Essen

  • Elisabeth Krankenhaus Essen

    Essen

  • Universitätsklinikum Essen

    Essen

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

  • Klinikum Fulda

    Fulda

  • Main-Kinzig-Kliniken

    Gelnhausen

  • Universitätsklinikum Gießen

    Giessen, 35392

  • Universitätsklinikum Göttingen

    Göttingen

  • Universitätsklinikum Greifswald

    Greifswald

  • Asklepios Klinik Harburg

    Hamburg

  • Asklepios Klinik St. Georg

    Hamburg

  • Universitäres Herzzentrum Eppendorf

    Hamburg

  • Med. Hochschule Hannover

    Hanover

  • SLK-Kliniken Heilbronn

    Heilbronn

  • Oberhavel Kliniken-Klinik Hennigsdorf

    Hennigsdorf

  • Krankenhaus Herford

    Herford

  • Herz- und Gefäßzentrum Oberallgäu-Kempten

    Immenstadt im Allgäu

  • Klinikum Itzehoe

    Itzehoe

  • Herz- und Gefäßzentrum Oberallgäu/Kempten

    Kempten, 87439

  • Stiftungsklinikum Mittelrhein

    Koblenz

  • Universitätsklinikum Leipzig

    Leipzig

  • Universitätsklinikum Schleswig Holstein

    Lübeck

  • Klinikum Lüdenscheid

    Lüdenscheid

  • Klinikum Ludwigshafen

    Ludwigshafen am Rhein, 67063

  • St. Marien-Hospital

    Lünen

  • Universitätsklinikum Magdeburg

    Magdeburg

  • Universitätsklinikum Mainz

    Mainz

  • Universitätsklinikum Mannheim

    Mannheim

  • Universitätsklinikum Marburg

    Marburg

  • Krankenhaus St. Franziskus Mönchengladbach

    Mönchengladbach

  • Evangelisches Krankenhaus Mülheim

    Mülheim

  • Deutsches Herzzentrum München

    Munich

  • Isar Herz Zentrum München

    Munich

  • Klinikum der Universität München , Campus Großhadern

    Munich

  • Klinikum München-Bogenhausen

    Munich

  • Städtisches Klinikum München - Neuperlach

    Munich

  • Universitätsmedizin Rostock

    Rostock

  • GPR Klinikum Rüsselsheim

    Rüsselsheim am Main

  • St. Marien-Krankenhaus

    Siegen

  • Elbe Klinikum Stade

    Stade

  • SRH Zentralklinikum Suhl

    Suhl

  • Universitätsklinikum Ulm

    Ulm

  • St. Marienhospital

    Vechta

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen

  • Rems-Murr-Klinik Winnenden

    Winnenden

  • Heinrich-Braun-Krankenhaus

    Zwickau

Other trials in Germany

Austria6 sites

  • Landeskrankenhaus-Univ.Klinikum Graz

    Graz

  • LKH Graz-West

    Graz

  • Medizinische Universität Innsbruck

    Innsbruck

  • A.ö. Krankenhaus der Stadt Linz

    Linz

  • Medizinische Universität Wien

    Vienna, State of Vienna, A-1090

  • LKH Villach

    Villach

Other trials in Austria

About this study

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

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.

Read the 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
Being tested
ABSORB Scaffold
Keywords
coronary artery stenosis, vascular scaffold, ABSORB
Medical subject headings
Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABSORB ScaffoldDevice

    Also called ABSORBTM Everolimus-eluting Bioresorbable Vascular 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

Study groups in NCT02066623
Study groupRoleWhat they receive
Implantation of ABSORB ScaffoldPatients suffering from coronary artery stenosis with an indication for implantation of ABSORB scaffold
Receives: Device: ABSORB Scaffold

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 5 years after index procedure

Secondary outcomes (1)

  1. 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

    Measured: during implantation of ABSORB scaffold

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2014 (estimated)
  2. Study start8 Nov 2013
  3. Primary completion31 Jan 2016
  4. Study completion6 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
3,330 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02066623
Sponsor's protocol ID
GABI-R
Acronym
GABI-R
Status last verified
Jul 2021
First submitted
20 Jan 2014
Last updated
1 Apr 2022
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26431767

  • 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.

    PubMed 28649953

  • 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.

    PubMed 28829745

  • 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.

    PubMed 29649071

  • 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.

    PubMed 31256259

  • 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.

    PubMed 32271247

  • 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.

    PubMed 31151213

  • 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.

    PubMed 35987601

  • 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.

    PubMed 34844868

  • 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.

    PubMed 34143547

  • 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.

    PubMed 32258361

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Stenosis, run by IHF GmbH - Institut für Herzinfarktforschung at 81 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of serious adverse cardiac events (time frame: 5 years after index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02066623, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.

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