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

NCT ID: NCT03269461

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2020-08-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

30 days evaluation

Angiography and Optical Coherence Tomography evaluations

Group Type: EXPERIMENTAL

Angiography and Optical Coherence Tomography evaluations

Intervention Type: DEVICE

coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations

2 months evaluation

Angiography and Optical Coherence Tomography evaluations

Group Type: EXPERIMENTAL

Angiography and Optical Coherence Tomography evaluations

Intervention Type: DEVICE

coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations

3 months evaluation

Angiography and Optical Coherence Tomography evaluations

Group Type: EXPERIMENTAL

Angiography and Optical Coherence Tomography evaluations

Intervention Type: DEVICE

coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations

Interventions

Angiography and Optical Coherence Tomography evaluations

coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scitech Produtos Medicos Ltda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Evangélico do Espírito Santo

Vila Velha, Espírito Santo, Brazil

Hospital do Coração Anis Rassi

Goiânia, Goiás, Brazil

Paraná Medical Research Center

Maringá, Paraná, Brazil

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

REPAIR

Identifier Type: -

Identifier Source: org_study_id