Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold
- Conditions
- Coronary Artery Stenosis
- Interventions
- Device: ABSORB Scaffold
- Registration Number
- NCT02066623
- Lead Sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3330
- ABSORB implant scheduled
- Age 18+
- Patients giving consent to keep scheduled follow-ups
- Signed informed consent
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Implantation of ABSORB Scaffold ABSORB Scaffold Patients suffering from coronary artery stenosis with an indication for implantation of ABSORB scaffold
- Primary Outcome Measures
Name Time Method Number of serious adverse cardiac events 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 Outcome Measures
Name Time Method Success of ABSORB implantation 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
Trial Locations
- Locations (81)
LKH Graz-West
🇦🇹Graz, 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
Hufeland Klinikum
🇩🇪Bad Langensalza, Germany
Kerckhoff-Klinik
🇩🇪Bad Nauheim, Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen
🇩🇪Bad Oeynhausen, Germany
Segeberger Kliniken GmbH
🇩🇪Bad Segeberg, Germany
Caritas-Klinik Pankow
🇩🇪Berlin, Germany
Segeberger Kliniken
🇩🇪Bad Segeberg, Germany
Charité - Universitätsmedizin Berlin-Campus Benjamin Franklin
🇩🇪Berlin, Germany
Charité - Universitätsmedizin Berlin - Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Vivantes Klinikum Spandau
🇩🇪Berlin, Germany
Vivantes-Klinikum Am Urban
🇩🇪Berlin, Germany
Vivantes Klinikum Neukölln
🇩🇪Berlin, Germany
Vivantesklinik im Friedrichshain
🇩🇪Berlin, Germany
Gesundheitszentrum Bitterfeld-Wolfen
🇩🇪Bitterfeld-Wolfen, Germany
Immanuel Klinikum Bernau
🇩🇪Bernau, Germany
St. Josef- und Elisabeth- Hospital
🇩🇪Bochum, Germany
Klinikum Links der Weser
🇩🇪Bremen, Germany
Krankenhaus Buchholz
🇩🇪Buchholz, Germany
Klinikum Coburg
🇩🇪Coburg, Germany
Kardiovaskuläres Zentrum Darmstadt
🇩🇪Darmstadt, Germany
Sana-Herzzentrum Cottbus
🇩🇪Cottbus, Germany
Praxisklinik Herz und Gefässe Dresden
🇩🇪Dresden, Germany
Werner-Forßmann-Krankenhaus
🇩🇪Eberswalde, Germany
Kliniken Im Naturpark Altmühltal, Klinik Eichstätt
🇩🇪Eichstätt, Germany
Alfried Krupp v. Bohlen Krankenhaus
🇩🇪Essen, Germany
Klinikum Fulda
🇩🇪Fulda, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Main-Kinzig-Kliniken
🇩🇪Gelnhausen, Germany
Elisabeth Krankenhaus Essen
🇩🇪Essen, Germany
Universitätsklinikum Gießen
🇩🇪Gießen, Germany
Universitätsklinikum Greifswald
🇩🇪Greifswald, Germany
Universitätsklinikum Göttingen
🇩🇪Göttingen, Germany
Asklepios Klinik Harburg
🇩🇪Hamburg, Germany
Med. Hochschule Hannover
🇩🇪Hannover, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Universitäres Herzzentrum Eppendorf
🇩🇪Hamburg, Germany
SLK-Kliniken Heilbronn
🇩🇪Heilbronn, Germany
Oberhavel Kliniken-Klinik Hennigsdorf
🇩🇪Hennigsdorf, Germany
Krankenhaus Herford
🇩🇪Herford, Germany
Klinikum Itzehoe
🇩🇪Itzehoe, Germany
Herz- und Gefäßzentrum Oberallgäu-Kempten
🇩🇪Immenstadt, Germany
Herzzentrum Universitätsklinikum Köln
🇩🇪Köln, Germany
Stiftungsklinikum Mittelrhein
🇩🇪Koblenz, Germany
Herz- und Gefäßzentrum Oberallgäu/Kempten
🇩🇪Kempten, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitätsklinikum Schleswig Holstein
🇩🇪Lübeck, Germany
Klinikum Ludwigshafen
🇩🇪Ludwigshafen am Rhein, Germany
Klinikum Lüdenscheid
🇩🇪Lüdenscheid, Germany
St. Marien-Hospital
🇩🇪Lünen, Germany
Universitätsklinikum Mainz
🇩🇪Mainz, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Universitätsklinikum Magdeburg
🇩🇪Magdeburg, Germany
Universitätsklinikum Marburg
🇩🇪Marburg, Germany
Deutsches Herzzentrum München
🇩🇪Munich, Germany
Isar Herz Zentrum München
🇩🇪Munich, Germany
Klinikum der Universität München , Campus Großhadern
🇩🇪Munich, Germany
Evangelisches Krankenhaus Mülheim
🇩🇪Mülheim, Germany
Städtisches Klinikum München - Neuperlach
🇩🇪Munich, Germany
Klinikum München-Bogenhausen
🇩🇪Munich, Germany
Krankenhaus St. Franziskus Mönchengladbach
🇩🇪Mönchengladbach, Germany
Universitätsmedizin Rostock
🇩🇪Rostock, Germany
GPR Klinikum Rüsselsheim
🇩🇪Rüsselsheim, Germany
Elbe Klinikum Stade
🇩🇪Stade, Germany
St. Marien-Krankenhaus
🇩🇪Siegen, 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, Germany
LKH Villach
🇦🇹Villach, Austria
Landeskrankenhaus-Univ.Klinikum Graz
🇦🇹Graz, Austria
A.ö. Krankenhaus der Stadt Linz
🇦🇹Linz, Austria
Medizinische Universität Wien
🇦🇹Vienna, Wien, Austria
Medizinische Universität Innsbruck
🇦🇹Innsbruck, Austria