Observational Study to Evaluate Short and Long-term Safet... | NCT02066623

Status Module

Name	Class
Abbott Medical Devices	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Implantation of ABSORB Scaffold		Patients suffering from coronary artery stenosis with an indication for implantation of ABSORB scaffold	Device: ABSORB Scaffold

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABSORB Scaffold	Device	Implantation of a drug-eluting vascular scaffold, which is completely resorbable to improve the blood flow in coronary arteries in the presence of stenosis

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Effectiveness of ABSORB implantation	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.

Eligibility Module

Name	Affiliation	Role
Christian Hamm, Prof. Dr.	University Clinic Giessen and Kerckhoff-Clinic Bad Nauheim	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Universität Wien		Vienna	State of Vienna	A-1090	Austria
Landeskrankenhaus-Univ.Klinikum Graz

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26431767	Background	Nef H, Wiebe J, Achenbach S, Munzel T, Naber C, Richardt G, Mehilli J, Wohrle J, Neumann T, Biermann J, Zahn R, Kastner J, Schmermund A, Pfannebecker T, Schneider S, Limbourg T, Hamm CW. Evaluation of the short- and long-term safety and therapy outcomes of the everolimus-eluting bioresorbable vascular scaffold system in patients with coronary artery stenosis: Rationale and design of the German-Austrian ABSORB RegIstRy (GABI-R). Cardiovasc Revasc Med. 2016 Jan-Feb;17(1):34-7. doi: 10.1016/j.carrev.2015.09.002. Epub 2015 Sep 10.
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