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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Diabetes Mellitus

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 3400

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10154
    • San Giovanni Bosco Hospital - ASL Città di Torino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All diabetic patients undergone percutaneous coronary intervention with insertion of drug eluting stents

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Amphilimus eluting stent; Diabetic patients treated with Cre8 Amphilimus eluting stent
Non Amphilimus eluting stent; Diabetic patients treated with any other drug eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ospedale S. Giovanni Bosco
• Investigators: Principal Investigator: Salvatore Colangelo, MD, San Giovanni Bosco Hospital - ASL Città di Torino

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: May 10, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Polymer free drug eluting stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 14942

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No