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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03269461
Recruitment Status : Completed
First Posted : August 31, 2017
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Scitech Produtos Medicos Ltda

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Angiography and Optical Coherence Tomography evaluations Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation
Actual Study Start Date : October 2, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : August 30, 2020
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Tissue Coverage [ Time Frame: 3 months ]
    Change in the tissue coverage percentage measured by OCT


Secondary Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269461


Locations
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Brazil
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, SP, Brazil
Sponsors and Collaborators
Scitech Produtos Medicos Ltda
More Information
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Responsible Party: Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier: NCT03269461    
Other Study ID Numbers: REPAIR
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scitech Produtos Medicos Ltda:
stent, DES, INSPIRON, OCT, tissue repair
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases