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

Completed

• Conditions: Coronary Artery Disease; Ischemic Heart Disease

• Registration Number: NCT04475536
• Lead Sponsor: Fundación EPIC

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 .

Study Timeline

• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-17
• Study Start: 2020-08-21
• Primary Completion: 2023-05-01
• Study Completion: 2024-02-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy.The incidence of clinically driven target lesion revascularization.	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).	12 months	The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).

Secondary Outcome Measures

Name	Time	Method
Rate of patients with DAPT	From 6 to 12 months	Rate of patients with DAPT
Stroke.	12 months	Stroke.
Target Vessel revascularization.	12 months	Target Vessel revascularization.
Cardiac death.	12 months	Cardiac death.
All death.	12 months	All death.
Target lesion revascularization.	12 months	Target lesion revascularization.
Stent thrombosis (ARC definite/probable).	12 months	Stent thrombosis (ARC definite/probable).
Major bleeding event (BARC type 2-5).	12 months	Major bleeding event (BARC type 2-5).
Procedural success.	12 months	Procedural success ( Residual stenosis \<30% after implantation at the narrowest point of the treated vascular segment).

Trial Locations

Locations (17)

Hospital Clinico Universitario de Santiago de Compostela; 🇪🇸 Santiago De Compostela, LA Coruña, Spain

Hospital General Universitario; 🇪🇸 Albacete, Spain

Hospital Del Mar; 🇪🇸 Barcelona, Spain

Hospital Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain

Hospital General Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Universitario de A Coruña; 🇪🇸 Coruña, Spain

Hospital Universitario Reina Sofia; 🇪🇸 Córdoba, Spain

Hospital Universitario de Cabueñes; 🇪🇸 Gijón, Spain

Hospital General Juan Ramon Jimenez; 🇪🇸 Huelva, Spain

Hospital Universitario de Gran Canaria Dr. Negrin; 🇪🇸 Las Palmas De Gran Canaria, Spain

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