Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Angiography and Optical Coherence Tomography evaluations

• Registration Number: NCT03269461
• Lead Sponsor: Scitech Produtos Medicos Ltda

Brief Summary

Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.

Detailed Description

The first 20 patients enrolled will be evaluated by angiography and Optical Coherence Tomography 3 months after stent implantation. The following 20 patients will be evaluated by the same methods 2 months after the implantation and the last 20 patients after 30 days.

All patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index procedure.

Study Timeline

• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-08-31
• Study Start: 2017-10-02
• Primary Completion: 2018-12-30
• Study Completion: 2020-08-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age ≥18 and ≤ 80years;
• Symptomatic CAD or documented myocardial ischemic disease;
• Up to 2 de novo lesions on native coronary arteries;
• Lesion length ≤ 29mm;
• Reference vessel diameter between ≥2.5 and ≤ 3.5 mm;
• Stenose at target lesion ≥ 70% and ≤ 99%.

Exclusion Criteria

• STEMI within the last 72 hours pre-procedure;
• renal insufficiency;
• Left Main stenosis > 50%;
• Ostial lesions;
• Bifurcation lesions with side branch ≥2mm;
• More than one lesion > 50% at the target vessel;
• Left Ejection Fraction less than 30%;
• Previous (less than 6 months) PCI at the target vessel.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
30 days evaluation	Angiography and Optical Coherence Tomography evaluations	Angiography and Optical Coherence Tomography evaluations
2 months evaluation	Angiography and Optical Coherence Tomography evaluations	Angiography and Optical Coherence Tomography evaluations
3 months evaluation	Angiography and Optical Coherence Tomography evaluations	Angiography and Optical Coherence Tomography evaluations

Primary Outcome Measures

Name	Time	Method
Tissue Coverage	3 months	Change in the tissue coverage percentage measured by OCT

Secondary Outcome Measures

Name	Time	Method
in-stent late lumen loss	3 months	in-stent late lumen loss
Target Vessel Failure	2 years	Target Vessel Failure (Death, MI and new revascularization)
Stent Thrombosis	2 years	Stent Thrombosis Rates

Trial Locations

Locations (5)

Instituto de Cardiologia do Rio Grande do Sul; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital do Coração Anis Rassi; 🇧🇷 Goiânia, Goiás, Brazil

Paraná Medical Research Center; 🇧🇷 Maringá, Paraná, Brazil

Hospital Evangélico do Espírito Santo; 🇧🇷 Vila Velha, Espírito Santo, Brazil

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 São Paulo, SP, Brazil