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

• Conditions: Coronary Artery Disease; Bifurcation Lesion
• Interventions: Device: Inspiron Sirolimus Eluting Stent

• Registration Number: NCT03780192
• Lead Sponsor: Scitech Produtos Medicos Ltda

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-02-28
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-17
• Primary Completion: 2021-02-15
• Study Completion: 2022-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	Inspiron Sirolimus Eluting Stent	Bifurcation lesion treatment using provisional stent technique

Primary Outcome Measures

Name	Time	Method
Percentage of Stenosis	day 0	% of stenosis on side branch after stent placement on main vessel

Trial Locations

Locations (1)

Hospital Moinhos de Vento; 🇧🇷 Porto Alegre, RS, Brazil