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

Fundación EPIC

Status: Completed

Conditions: Coronary Artery Disease; Ischemic Heart Disease

Treatments: Device: TANSEI stent

Study type: Observational

Funder types: Other

Identifiers

NCT04475536

EPIC08-TANSEI

Details and patient eligibility

About

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

Full description

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

Enrollment: 501 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

501 participants in 1 patient group

Coronary Artery Disease (CAD)

Treatment:

Device: TANSEI stent