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Clinical Trials/NCT04475536
NCT04475536
Completed
Not Applicable

A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.

Fundación EPIC17 sites in 1 country501 target enrollmentAugust 21, 2020
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ConditionsIschemic Heart DiseaseCoronary Artery Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Heart Disease
Sponsor
Fundación EPIC
Enrollment
501
Locations
17
Primary Endpoint
Efficacy.The incidence of clinically driven target lesion revascularization.
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.

Detailed Description

This prospective registry is intended to analyze clinical outcomes in patients treated with TANSEI stent in patients with complex coronary lesions .

Registry
clinicaltrials.gov
Start Date
August 21, 2020
End Date
February 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Fundación EPIC
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Age\> 18 years.
  • •With indication of percutaneous revascularization.
  • •Complex coronary lesion defined as:
  • •Left main lesion AND/OR
  • •Lesion located at a major bifurcation (side branch \>2mm) AND/OR
  • •Lesion located in a small vessel (\<2.5 mm reference diameter by visual estimation) AND/OR
  • •Lesion length \> 35 mm
  • •Informed consent signed.

Exclusion Criteria

  • •Cardiogenic shock at the time of the PCI(Percutaneous Coronary Intervention).
  • •Life expectancy of the patient under 1 year.
  • •Patients included in other studies or clinical trials.
  • •Clinical decision that excludes the use of drug-eluting stents.
  • •Confirmed allergy to aspirin and / or thienopyridines.

Outcomes

Primary Outcomes

Efficacy.The incidence of clinically driven target lesion revascularization.

Time Frame: 12 months

The incidence of clinically driven target lesion revascularization (TLR).

Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).

Time Frame: 12 months

The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).

Secondary Outcomes

  • Target Vessel revascularization.(12 months)
  • Cardiac death.(12 months)
  • All death.(12 months)
  • Target lesion revascularization.(12 months)
  • Rate of patients with DAPT(From 6 to 12 months)
  • Stent thrombosis (ARC definite/probable).(12 months)
  • Major bleeding event (BARC type 2-5).(12 months)
  • Stroke.(12 months)
  • Procedural success.(12 months)

Study Sites (17)

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