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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03269461

Acronym

REPAIR

Enrollment

Registered

2017-08-31

Start date

2017-10-02

Completion date

2020-08-30

Last updated

2020-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

stent, DES, INSPIRON, OCT, tissue repair

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.

Interventions

DEVICEAngiography and Optical Coherence Tomography evaluations

coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Tissue Coverage	3 months	Change in the tissue coverage percentage measured by OCT

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026