INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique (insProvisional)

Scitech Produtos Medicos

Status: Unknown

Conditions: Coronary Artery Disease; Bifurcation Lesion

Treatments: Device: Inspiron Sirolimus Eluting Stent

Study type: Observational

Funder types: Industry

Identifiers

NCT03780192

SC-INS-001-2019

Details and patient eligibility

About

Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with coronary artery disease on bifurcation anatomy with indication of drug eluting stent implantation , on which the side branch is ≥ 2.5 mm diameter and ostial stenosis ≤50% (Medina 1-1-0, 1-0-0, 0-1-0).

Exclusion criteria

• Acute Myocardial Infarction (STMI);
• Chronic occlusion;
• Cardiogenic shock;
• Ejection fraction ≤ 20%;
• Thrombocytopenia (≤ 50 mil);
• DAPT contraindication;
• Life expectancy of less than 12 months.

Trial design

80 participants in 1 patient group

Treatment

Description:

Bifurcation lesion treatment using provisional stent technique

Treatment:

Device: Inspiron Sirolimus Eluting Stent