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

NCT ID: NCT03780192

Last Updated: 2020-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2022-02-15

Brief Summary

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.

Conditions

Bifurcation Lesion; Coronary Artery Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment

Bifurcation lesion treatment using provisional stent technique

Inspiron Sirolimus Eluting Stent

Intervention Type: DEVICE

Bifurcation treatment using provisional stent technique

Interventions

Inspiron Sirolimus Eluting Stent

Bifurcation treatment using provisional stent technique

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scitech Produtos Medicos Ltda

INDUSTRY

Sponsor Role: lead

Responsible Party

Marco Vugman Wainstein

Principal Investigator Hospital Moinhos de Vento

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Marco Wainstein, MD

Role: CONTACT

marco.wainstein@hmv.org.br

+555133143537

Facility Contacts

Marco Wainstein, MD

Role: primary

marco.wainstein@hmv.org.br

Other Identifiers

SC-INS-001-2019

Identifier Type: -

Identifier Source: org_study_id