Coronary Artery Stenosis
Conditions
Keywords
coronary artery stenosis, vascular scaffold, ABSORB
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
Interventions
DEVICEABSORB 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
Sponsors
Abbott Medical Devices
IHF GmbH - Institut für Herzinfarktforschung
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ABSORB implant scheduled * Age 18+ * Patients giving consent to keep scheduled follow-ups * Signed informed consent
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of ABSORB implantation | 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. |
| Change in quality of life | 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) |
| Health-economical effects of ABSORB scaffold implantation | 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 |
Countries
Austria, Germany
Outcome results
None listed