Overview

This trial is active, not recruiting.

Condition coronary artery stenosis
Treatment absorb scaffold
Sponsor IHF GmbH - Institut für Herzinfarktforschung
Collaborator Abbott Vascular
Start date November 2013
End date March 2021
Trial size 3329 participants
Trial identifier NCT02066623, GABI-R

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients suffering from coronary artery stenosis with an indication for implantation of ABSORB scaffold
absorb scaffold ABSORBTM Everolimus-eluting Bioresorbable Vascular 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

Primary Outcomes

Measure
Number of serious adverse cardiac events
time frame: 5 years after index procedure

Secondary Outcomes

Measure
Success of ABSORB implantation
time frame: during implantation of ABSORB scaffold

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - ABSORB implant scheduled - Age 18+ - Patients giving consent to keep scheduled follow-ups - Signed informed consent Exclusion Criteria:

Additional Information

Official title 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
Principal investigator Christian Hamm, Prof. Dr.
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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by IHF GmbH - Institut für Herzinfarktforschung.