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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Coronary Artery Stenosis

Intervention / Treatment
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* Device: ABSORB Scaffold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ABSORB implant scheduled Age 18+ Patients giving consent to keep scheduled follow-ups Signed informed consent Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Implantation of ABSORB Scaffold<br>Patients suffering from coronary artery stenosis with an indication for implantation of ABSORB scaffold | Device: ABSORB Scaffold<br>* Implantation of a drug-eluting vascular scaffold, which is completely resorbable to improve the blood flow in coronary arteries in the presence of stenosis<br>* Other names: ABSORBTM Everolimus-eluting Bioresorbable Vascular Scaffold;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 years after index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | during implantation of ABSORB scaffold | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery stenosis, vascular scaffold, ABSORB