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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Angiography and Optical Coherence Tomography evaluations

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Espírito Santo
    • Vila Velha, Espírito Santo, Brazil
      • Hospital Evangélico do Espírito Santo
  • Goiás
    • Goiânia, Goiás, Brazil
      • Hospital do Coração Anis Rassi
  • Paraná
    • Maringá, Paraná, Brazil
      • Parana Medical Research Center
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Instituto de Cardiologia do Rio Grande do Sul
  • SP
    • São Paulo, SP, Brazil
      • Instituto Dante Pazzanese de Cardiologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 30 days evaluation; Angiography and Optical Coherence Tomography evaluations	Device: Angiography and Optical Coherence Tomography evaluations; coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations
Experimental: 2 months evaluation; Angiography and Optical Coherence Tomography evaluations	Device: Angiography and Optical Coherence Tomography evaluations; coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations
Experimental: 3 months evaluation; Angiography and Optical Coherence Tomography evaluations	Device: Angiography and Optical Coherence Tomography evaluations; coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Scitech Produtos Medicos Ltda

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: stent, DES, INSPIRON, OCT, tissue repair
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: REPAIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No