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Completed

NCT Number: NCT03269461

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

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

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Key information

Conditions

Coronary Artery Disease Amino Acid Metabolism, Inborn Errors Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cardiovascular Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary Disease Dysequilibrium syndrome Genetic Diseases, Inborn Genetic Diseases, X-Linked Heart Diseases Metabolic Diseases Metabolism, Inborn Errors Myocardial Ischemia Nervous System Diseases Nutritional and Metabolic Diseases Ornithine Carbamoyltransferase Deficiency Disease Urea Cycle Disorders, Inborn Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Evangélico do Espírito Santo, Vila Velha, Espírito Santo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Angiography and Optical Coherence Tomography evaluations

Device

coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations

Primary outcomes

  1. Tissue Coverage

    Time frame: 3 months

    Change in the tissue coverage percentage measured by OCT

Secondary outcomes

  1. in-stent late lumen loss

    Time frame: 3 months

    in-stent late lumen loss

  2. Stent Thrombosis

    Time frame: 2 years

    Stent Thrombosis Rates

  3. Target Vessel Failure

    Time frame: 2 years

    Target Vessel Failure (Death, MI and new revascularization)

Sponsors and collaborators

Lead sponsor

Scitech Produtos Medicos SA

Industry

Registry information

Acronym: REPAIR

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Aug 31, 2017
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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