NCT02066623

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,330 (actual)
• Sponsor: IHF GmbH - Institut für Herzinfarktforschung · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Coronary Artery Stenosis

Interventions

Type	Name	Description
DEVICE	ABSORB 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

Timeline

• Start date: 2013-11-08
• Primary completion: 2016-01-31
• Completion: 2021-07-06
• First posted: 2014-02-19
• Last updated: 2022-04-01

Locations

81 sites across 2 countries: Austria, Germany