Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold (GABI-R)

IHF GmbH - Institut für Herzinfarktforschung

Status

Completed

Conditions

Coronary Artery Stenosis

Treatments

Device: ABSORB Scaffold

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02066623

GABI-R

Details and patient eligibility

About

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.

Full 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

Enrollment

3,330 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria