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.
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
3,330
Implantation of a drug-eluting vascular scaffold, which is completely resorbable to improve the blood flow in coronary arteries in the presence of stenosis
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
Time frame: 5 years after index procedure
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
Time frame: during implantation of ABSORB scaffold
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Medizinische Universität Wien
Vienna, State of Vienna, 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
LKH Villach
Villach, Austria
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
...and 71 more locations