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

NCT03651180 | Unknown DMC

• 1 other identifier: 14942
• Study Type: observational
• Target: 3,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Diabetes Mellitus

Keywords

Polymer free drug eluting stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  1 year

Study Arms (2)

Amphilimus eluting stent

Diabetic patients treated with Cre8 Amphilimus eluting stent

Non Amphilimus eluting stent

Diabetic patients treated with any other drug eluting stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale S. Giovanni Bosco: lead

Study Sites (1)

San Giovanni Bosco Hospital - ASL Città di Torino

Turin, 10154, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Salvatore Colangelo, MD

  San Giovanni Bosco Hospital - ASL Città di Torino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: August 29, 2018
• Study Start: August 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2023
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

IT (1)