Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion (BIO-RESORT)

Coronary Artery Disease Clinical Trial

— BIO-RESORT  

Official title:

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion: Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674803
• Other study ID #: BIO-RESORT
• Status: Completed
• Phase: N/A
• Start date: December 21, 2012
• Est. completion date: August 25, 2020

Study information

• Verified date: July 2022
• Source: Foundation of Cardiovascular Research and Education Enschede
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with biodegradable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such biodegradable polymer DES are increasingly used in clinical practice, there is no data available from head-to-head comparisons between biodegradable and contemporary third generation durable polymer DES.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3514
• Est. completion date: August 25, 2020
• Est. primary completion date: August 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Minimum age of 18 years.

• Significant coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement.

• Capable of providing informed consent.

• Patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location, or length of lesions to be treated.

Exclusion Criteria:

• Known intolerance to components of one of the stents that will be investigated or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to dual antiplatelet therapy.

• Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization.

• Participation in another randomized drug or device trial before reaching primary endpoint.

• Adherence to scheduled follow-up is unlikely or life expectancy assumed to be less than 1 year.

• Known pregnancy

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Coronary Stenosis
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• Orsiro
biodegradable polymer sirolimus eluting stent
• Synergy
biodegradable polymer everolimus eluting stent
• Resolute Integrity
durable polymer zotarolimus-eluting stent

Locations

Country	Name	City	State
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht

Sponsors (1)

Lead Sponsor	Collaborator
Foundation of Cardiovascular Research and Education Enschede

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target vessel failure (TVF)	Target vessel failure is a combined endpoint of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization.	1 year
Secondary	Target lesion failure (TLF)	Target lesion failure is a combined endpoint of cardiac death, target vessel related myocardial infarction, and clinically driven target lesion revascularization	1 year