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

Scitech Produtos Medicos

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Angiography and Optical Coherence Tomography evaluations

Study type: Interventional

Funder types: Industry

Identifiers

NCT03269461

REPAIR

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

30 days evaluation

Experimental group

Description:

Angiography and Optical Coherence Tomography evaluations

Treatment:

Device: Angiography and Optical Coherence Tomography evaluations

2 months evaluation

Experimental group

Description:

Angiography and Optical Coherence Tomography evaluations

Treatment:

Device: Angiography and Optical Coherence Tomography evaluations

3 months evaluation

Experimental group

Description:

Angiography and Optical Coherence Tomography evaluations

Treatment:

Device: Angiography and Optical Coherence Tomography evaluations