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

NCT ID: NCT03651180

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2023-10-01

Brief 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.

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.

Conditions

Coronary Artery Disease; Diabetes Mellitus

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Amphilimus eluting stent

Diabetic patients treated with Cre8 Amphilimus eluting stent

No interventions assigned to this group

Non Amphilimus eluting stent

Diabetic patients treated with any other drug eluting stent

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale S. Giovanni Bosco

OTHER

Sponsor Role: lead

Responsible Party

Salvatore Colangelo MD

Interventional Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salvatore Colangelo, MD

Role: PRINCIPAL_INVESTIGATOR

San Giovanni Bosco Hospital - ASL Città di Torino

Locations

San Giovanni Bosco Hospital - ASL Città di Torino

Turin, , Italy

Countries

Italy

Other Identifiers

14942

Identifier Type: -

Identifier Source: org_study_id