Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold (GABI-R)

March 31, 2022 updated by: IHF GmbH - Institut für Herzinfarktforschung

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

3330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Landeskrankenhaus-Univ.Klinikum Graz
      • Graz, Austria
        • LKH Graz-West
      • Innsbruck, Austria
        • Medizinische Universität Innsbruck
      • Linz, Austria
        • A.ö. Krankenhaus der Stadt Linz
      • Villach, Austria
        • LKH Villach
    • Wien
      • Vienna, Wien, Austria, A-1090
        • Medizinische Universität Wien
  • Germany
      • Arnstadt, Germany
        • Ilm-Kreis-Kliniken, Arnstadt-Ilmenau
      • Bad Berka, Germany
        • Zentralklinik Bad Berka
      • Bad Friedrichshall, Germany
        • SLK-Kliniken, Klinikum am Plattenwald
      • Bad Krozingen, Germany
        • Herzzentrum Bad Krozingen
      • Bad Langensalza, Germany
        • Hufeland Klinikum
      • Bad Nauheim, Germany
        • Kerckhoff-Klinik
      • Bad Oeynhausen, Germany
        • Herz- und Diabeteszentrum Nordrhein-Westfalen
      • Bad Segeberg, Germany, 23795
        • Segeberger Kliniken GmbH
      • Bad Segeberg, Germany
        • Segeberger Kliniken
      • Berlin, Germany
        • Vivantes Klinikum Neukölln
      • Berlin, Germany
        • Vivantes Klinikum Spandau
      • Berlin, Germany
        • Vivantes-Klinikum am Urban
      • Berlin, Germany
        • Caritas-Klinik Pankow
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin - Campus Virchow-Klinikum
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin-Campus Benjamin Franklin
      • Berlin, Germany
        • Vivantesklinik im Friedrichshain
      • Bernau, Germany
        • Immanuel Klinikum Bernau
      • Bitterfeld-Wolfen, Germany
        • Gesundheitszentrum Bitterfeld-Wolfen
      • Bochum, Germany
        • St. Josef- und Elisabeth- Hospital
      • Bremen, Germany
        • Klinikum Links der Weser
      • Buchholz, Germany
        • Krankenhaus Buchholz
      • Coburg, Germany
        • Klinikum Coburg
      • Cottbus, Germany
        • Sana-Herzzentrum Cottbus
      • Darmstadt, Germany
        • Kardiovaskuläres Zentrum Darmstadt
      • Dresden, Germany
        • Praxisklinik Herz und Gefässe Dresden
      • Eberswalde, Germany
        • Werner-Forßmann-Krankenhaus
      • Eichstätt, Germany
        • Kliniken Im Naturpark Altmühltal, Klinik Eichstätt
      • Erlangen, Germany
        • Universitätsklinikum Erlangen
      • Essen, Germany
        • Universitätsklinikum Essen
      • Essen, Germany
        • Elisabeth Krankenhaus Essen
      • Essen, Germany
        • Alfried Krupp v. Bohlen Krankenhaus
      • Freiburg, Germany
        • Universitätsklinikum Freiburg
      • Fulda, Germany
        • Klinikum Fulda
      • Gelnhausen, Germany
        • Main-Kinzig-Kliniken
      • Gießen, Germany, 35392
        • Universitätsklinikum Giessen
      • Greifswald, Germany
        • Universitätsklinikum Greifswald
      • Göttingen, Germany
        • Universitätsklinikum Göttingen
      • Hamburg, Germany
        • Asklepios Klinik St. Georg
      • Hamburg, Germany
        • Asklepios Klinik Harburg
      • Hamburg, Germany
        • Universitäres Herzzentrum Eppendorf
      • Hannover, Germany
        • Med. Hochschule Hannover
      • Heilbronn, Germany
        • SLK-Kliniken Heilbronn
      • Hennigsdorf, Germany
        • Oberhavel Kliniken-Klinik Hennigsdorf
      • Herford, Germany
        • Krankenhaus Herford
      • Immenstadt, Germany
        • Herz- und Gefäßzentrum Oberallgäu-Kempten
      • Itzehoe, Germany
        • Klinikum Itzehoe
      • Kempten, Germany, 87439
        • Herz- und Gefäßzentrum Oberallgäu/Kempten
      • Koblenz, Germany
        • Stiftungsklinikum Mittelrhein
      • Köln, Germany
        • Herzzentrum Universitätsklinikum Koln
      • Leipzig, Germany
        • Universitatsklinikum Leipzig
      • Ludwigshafen am Rhein, Germany, 67063
        • Klinikum Ludwigshafen
      • Lübeck, Germany
        • Universitätsklinikum Schleswig Holstein
      • Lüdenscheid, Germany
        • Klinikum Lüdenscheid
      • Lünen, Germany
        • St. Marien-Hospital
      • Magdeburg, Germany
        • Universitätsklinikum Magdeburg
      • Mainz, Germany
        • Universitätsklinikum Mainz
      • Mannheim, Germany
        • Universitätsklinikum Mannheim
      • Marburg, Germany
        • Universitätsklinikum Marburg
      • Munich, Germany
        • Deutsches Herzzentrum München
      • Munich, Germany
        • Klinikum München-Bogenhausen
      • Munich, Germany
        • Isar Herz Zentrum München
      • Munich, Germany
        • Klinikum der Universität München , Campus Großhadern
      • Munich, Germany
        • Städtisches Klinikum München - Neuperlach
      • Mönchengladbach, Germany
        • Krankenhaus St. Franziskus Mönchengladbach
      • Mülheim, Germany
        • Evangelisches Krankenhaus Mülheim
      • Rostock, Germany
        • Universitätsmedizin Rostock
      • Rüsselsheim, Germany
        • GPR Klinikum Rüsselsheim
      • Siegen, Germany
        • St. Marien-Krankenhaus
      • Stade, Germany
        • Elbe Klinikum Stade
      • Suhl, Germany
        • SRH Zentralklinikum Suhl
      • Ulm, Germany
        • Universitätsklinikum Ulm
      • Vechta, Germany
        • St. Marienhospital
      • Villingen-Schwenningen, Germany
        • Schwarzwald-Baar Klinikum
      • Winnenden, Germany
        • Rems-Murr-Klinik Winnenden
      • Zwickau, Germany
        • Heinrich-Braun-Krankenhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Implantation of ABSORB Scaffold
Patients suffering from coronary artery stenosis with an indication for implantation of ABSORB scaffold
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
Other Names:
  • ABSORBTM Everolimus-eluting Bioresorbable Vascular Scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of serious adverse cardiac events
Time Frame: 5 years after index procedure

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of ABSORB implantation
Time Frame: during implantation of ABSORB scaffold

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of ABSORB implantation
Time Frame: 5 years follow-up period

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
Change in quality of life
Time Frame: 5 years follow-up period

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
Health-economical effects of ABSORB scaffold implantation
Time Frame: 5 years follow-up period

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IHF GmbH - Institut für Herzinfarktforschung

Collaborators

Abbott Medical Devices

Investigators

  • Principal Investigator: Christian Hamm, Prof. Dr., University Clinic Giessen and Kerckhoff-Clinic Bad Nauheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2013

Primary Completion (Actual)

January 31, 2016

Study Completion (Actual)

July 6, 2021

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

February 17, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GABI-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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