Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents

Coronary Artery Disease Clinical Trial

— EVERBIOII  

Official title:

Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711931
• Other study ID #: 043/12-CER-FR
• Status: Completed
• Phase: Phase 4
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: University of Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of everolimus- and biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.

The null hypothesis to be rejected is that there is no significant difference with regard to lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting bioresorbable vascular scaffold stents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• elective PCI

• ability and willingness to provide written informed consent

Exclusion Criteria:

• ST-elevation myocardial infarction in the previous 48 hours

• moderate to severe renal failure (defined as creatinine clearance of 30-60 ml/min and <30ml/min respectively)

• known or presumed hypersensitivity to heparin, antiplatelet drugs and hypersensitivity to contrast dye incontrollable with premedication

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Implantation of everolimus-eluting bioresorbable vascular scaffold stent

• Implantation of everolimus-eluting stents

• Implantation of biolimus-eluting stents

Locations

Country	Name	City	State
Switzerland	Fribourg Cantonal Hospital	Fribourg

Sponsors (1)

Lead Sponsor	Collaborator
University of Freiburg

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Arroyo D, Togni M, Puricel S, Gerard B, Sonja L, Corpataux N, Villeneuve H, Boute E, Stauffer JC, Goy JJ, Cook S. Comparison of everolimus-eluting and biolimus-eluting coronary stents with everolimus-eluting bioresorbable scaffold: study protocol of the r — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stent thrombosis	possible, probable and definite stent thrombosis	up to 5 years
Other	Periprocedural Complications (occurring <48 hours after the Intervention)	Type 4A MI Dissection Perforation	Periprocedural
Primary	Lumen Late Loss	as assessed by quantitative coronary angiogram	9 months
Secondary	Device-oriented major adverse cardiac events	The composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel) and target lesion revascularization	6 months, 1, 2, 5 years
Secondary	Patient-oriented major adverse cardiac events	The composite of all-cause mortality, any myocardial infarction and any revascularization	6 months, 1, 2, 5 years