Efficacy and Safety of Coronary Amphilimus-ELuting Stent in diAbeTic patiEnts

Coronary Artery Disease Clinical Trial

— ESCALATE  

Official title:

Efficacy and Safety of Coronary Amphilimus-ELuting Stent in diAbeTic patiEnts: a Cross-sectional Multicentre Consecutive Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03651180
• Other study ID #: 14942
• Status: Active, not recruiting
• Start date: August 1, 2018
• Est. completion date: October 1, 2023

Study information

• Verified date: August 2018
• Source: Ospedale S. Giovanni Bosco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

More recently a polymer-free drug eluting stent (Amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. However, to date there are no direct comparisons of these two type of drug eluting stents.

Description:

Drug eluting stent is the cornerstone of treatment in diabetic patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, there are a considerable number of patients who continue to have major adverse event despite this treatment. More recently a polymer-free drug eluting stent (Amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. These more favorable effects translate into reduced event rates, but to date there are no existing data comparing directly the mid-long term effect of this new polymer-free drug eluting stent with the other drug eluting stents in a larger cohort of patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3400
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• diagnosis of insulin or non-insulin dependent diabetes mellitus treated from at least 1 month

• if basal blood sugar at the admission is above 200 mg / dl or hemoglobin levels glycated> 6.5% (> 48 mmol / mol)

Exclusion Criteria:

• inability to provide informed consent or unable to guarantee the possibility of be contacted in the following 12 months;

• age under 18 years or over 80 years

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Locations

Country	Name	City	State
Italy	San Giovanni Bosco Hospital - ASL Città di Torino	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale S. Giovanni Bosco

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of the composite endpoint of cardiac death, definite and probable stent thrombosis, re-PCI, Target Vessel Revascularization and bleeding in the two groups of study	Evaluation and comparison of the composite endpont of cardiac death, definite and probable stent thrombosis according with Academic Research Consortium criteria, Re-PCI, Target Vessel Revascularization, Type III and V bleeding complications according with Bleeding Academic Research Consortium criteria in the two groups of study	1 year
Secondary	Incidence of every single adverse event (cardiac death, definite and probable stent thrombosis, re-PCI, Target Vessel Revascularization and bleeding) in the two groups of study	Measurements and comparison of the incidence of any single adverse event of the composite endpoint (cardiac death, definite and probable stent thrombosis according with Academic Research Consortium criteria, Re-PCI, Target Vessel Revascularization, Type III and V bleeding complications according with Bleeding Academic Research Consortium criteria) in the two groups of study	1 year