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Completed

NCT Number: NCT02066623

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

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.

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Key information

Conditions

Coronary Artery Stenosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Wien, Vienna, State of Vienna, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

ABSORB Scaffold

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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.

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

IHF GmbH - Institut für Herzinfarktforschung

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study 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

Acronym: GABI-R

Important dates

Study start
2013
Primary completion
2016
Study completion
2021
First posted
Feb 19, 2014
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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