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

Coronary Artery Disease Clinical Trial

— insProvisional  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03780192
• Other study ID #: SC-INS-001-2019
• Status: Recruiting
• Start date: February 28, 2019
• Est. completion date: February 15, 2022

Study information

• Verified date: March 2020
• Source: Scitech Produtos Medicos Ltda
• Contact: Marco Wainstein, MD
• Phone: +555133143537
• Email: marco.wainstein[@]hmv.org.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bifurcation Lesion
• Coronary Artery Disease

Intervention

Device:
• Inspiron Sirolimus Eluting Stent
Bifurcation treatment using provisional stent technique

Locations

Country	Name	City	State
Brazil	Hospital Moinhos de Vento	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Scitech Produtos Medicos Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Stenosis	% of stenosis on side branch after stent placement on main vessel	day 0